3 Ways eConsent Tackles the Challenges of Modern Clinical Trials

September 28th, 2021 by

Although eConsent struggled to gain momentum and wider acceptance pre-pandemic, it is actually powered by technology that is regularly used in daily life and is more approachable than one might think. Regardless, some researchers are still hesitant to embrace remote technology. In this article, we’ll explore three areas that researchers cite as obstacles when implementing eConsent: data safety; regulatory compliance; and identity verification. Read on to learn how these issues can be resolved safely and efficiently.

Playing it safe with data

Data integrity, safety, and privacy are of critical importance these days. And with good reason—never before has so much personal data been processed through online services. Since medical data is among the most private there is, clinical trials must adhere to the highest standards of data protection while offering their participants data privacy. Fortunately, there are several ways to accomplish this via  eConsent.

In order to keep data safe and secure, opt for an eConsent solution with:

When employing eConsent, investigators should use embedded HIPAA-compliant authorization forms to ensure FDA compliance. In the EU, the GDPR’s most recent guidance requires “an effective audit trail of how and when consent was given, so you can provide evidence if challenged” and “an appropriate cryptographic hash function to support data integrity.” 

Any video conferencing used as part of eConsent must be secure, traceable, and fully compliant. For example, it should be encrypted and US 21 CFR Part 11 compliant. 

Navigating the regulatory jungle

The regulatory jungle is complex enough to discourage researchers from changing established methods they know are fully compliant (or that they believe are fully compliant). . It doesn’t help that different countries and regions have their own regulations around the use of eConsent and acceptance of eSignatures. At the time of writing, the FDA’s most recent guidance was published in December 2016 and no EU regulation or guidance about eConsent in clinical trials exists.

Ensuring regulatory compliance is not hopeless, however. In general, Institutional Review Boards (IRBs) and ethics committee have consistent requirements for paper and electronic consent, such as:

Researchers need to familiarize themselves with their applicable IRB guidelines. (Find a handy overview of eConsent guidelines in twelve different countries here.) When making a submission for an eConsent-based study, it’s important to also address:

Checking IDs at the door

Clinical investigators need to confirm the identity of all participants in a trial according to regulatory requirements. But that doesn’t mean every participant needs to present themselves at the study site—video conferencing to the rescue!

An appropriate, secure video conferencing solution provides investigators with real-time, visual interaction with participants. This allows the study team to verify the identity and, if using a hybrid wet-signature with eConsent, witness the signature of each participant. But the benefits don’t end there—video conferencing allows a clinical researcher to answer questions directly, cementing trust with a participant and increasing retention. Importantly, investigators are able to observe the participant’s behavior and determine if they are capable of offering informed consent and are consenting of their own free will.

Castor eConsent is a flexible, user-friendly, and secure solution for your next trial. If you’re interested in learning more about putting eConsent to work in your next trial, reach out to one of our friendly Castorians here.

Comments closed

EQ-5D in European Trials: When Generic QoL Measures Actually Matter

August 26th, 2025 by

Many European biotechs discover that FDA-focused PRO strategies overlook valuable reimbursement opportunities across European markets. Companies repositioning EQ-5D from “regulatory necessity” to “HTA advantage” often secure faster reimbursement approvals, while acknowledging that the same data contributes minimal value to FDA label claims.

This reality reflects the fundamental misalignment between vendor marketing and regulatory practice: EQ-5D’s value lies in European health technology assessment, not US regulatory acceptance.

The Regulatory Reality Check

Analysis of 735 FDA drug approvals found 0% included EQ-5D data in product labeling, while only 5% mentioned it in supporting documentation [Shaw et al. 2024]. Meanwhile, European Medicines Agency acceptance reached 5% for labeling support which is limited but measurably better than FDA’s complete resistance.

FDA‘s opposition to generic quality of life measures stems from fundamental concerns: generic instruments lack sensitivity to detect small therapeutic benefits and cannot distinguish treatment-specific adverse effects. Their preference for disease-specific PRO measures reflects regulatory pragmatism, not methodological bias.

Where EQ-5D Actually Succeeds

EQ-5D’s strength lies in European health technology assessment, not clinical outcome measurement:

German HTA Bodies: Analysis shows strong EQ-5D acceptance in German HTA processes, with IQWiG and G-BA demonstrating systematic usage when quality of life assessment is included [Shaw et al. 2024]. German bodies show notable acceptance for clinical outcome assessment among European regulators.

NICE Guidelines: NICE continues to recommend EQ-5D for cost-utility analysis while maintaining the 2019 position on EQ-5D-5L value sets, requiring mapping to 3L values for consistency [NICE 2019].

French HAS: Recognizes EQ-5D within their health economic evaluation methodology, though specific usage varies by therapeutic area and assessment context [HAS 2020].

Understanding EQ-5D’s Actual Structure

EQ-5D is a simple, 5-question static questionnaire. The instrument covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, plus the EQ-VAS rating overall health from 0-100.

No special site training or certification is required for standard administration. The 2-3 minute completion time reflects genuine simplicity, not algorithmic optimization. This simplicity explains both EQ-5D’s broad adoption and its regulatory limitations.

When EQ-5D Doesn’t Work

Avoid EQ-5D as primary strategy when:

  • FDA labeling claims are your primary objective (0% success rate)
  • Disease-specific outcome measurement is regulatory requirement
  • Ceiling effects are expected in your patient population
  • Sensitivity to small therapeutic benefits is crucial for approval

Implementation limitations to acknowledge:

  • Generic nature misses condition-specific improvements
  • Statistical analysis challenges affect many studies due to missing data and ceiling effects [Pickard et al. 2007]
  • No special training requirements means limited differentiation from competitor implementations

The Economic Reality

EQ-5D’s true value lies in quality-adjusted life year (QALY) calculations essential for European health technology assessment. The instrument provides standardized utility values across therapeutic areas, enabling cost-effectiveness analysis required by most European reimbursement bodies.

However, this economic value shouldn’t be confused with regulatory acceptance. Analysis shows clinical outcome assessment represents approximately 18% of EQ-5D usage in technology appraisals, with the majority focused on economic evaluation [Shaw et al. 2024].

Your Practical Implementation Plan

Immediate Assessment (This Week)

  1. Clarify regulatory objectives: Determine whether your primary need is FDA labeling, European regulatory support, or HTA economic modeling
  2. Review current PRO strategy: Assess whether disease-specific measures are already planned for regulatory endpoints
  3. Evaluate HTA requirements: Identify which European markets require QALY data for reimbursement decisions

Strategic Planning (Next 2-4 Weeks)

  1. HTA body consultation: Engage with NICE, G-BA, or relevant bodies on EQ-5D requirements for your therapeutic area
  2. Platform assessment: Ensure your clinical trial solutions support both EQ-5D data collection and economic analysis
  3. Budget allocation: Plan implementation costs focusing on health economic value rather than regulatory claims
  4. Timeline integration: Coordinate EQ-5D deployment with broader European market access strategy

Implementation Excellence (Following 12-22 Weeks)

  1. HTA-focused deployment: Prioritize data quality for economic modeling over regulatory claim support
  2. Country-specific optimization: Apply appropriate value sets and preference weights by market
  3. Economic analysis preparation: Generate QALY calculations supporting reimbursement submissions
  4. Realistic outcome measurement: Track HTA acceptance rates rather than regulatory approval metrics

Frequently Asked Questions

Why do vendors position EQ-5D as “regulatory accepted” if FDA acceptance is 0%?

Vendor marketing often conflates HTA acceptance with regulatory approval. While EQ-5D has established HTA positioning, particularly with NICE’s continued preference, this differs significantly from regulatory labeling acceptance. The distinction matters for setting realistic expectations and budget allocation.

Should I avoid EQ-5D entirely for US trials?

Not necessarily. EQ-5D can provide valuable health economic modeling data for US payers and HTA bodies like ICER. However, expect zero contribution to FDA labeling claims and plan disease-specific measures for regulatory endpoints.

How do I maximize EQ-5D’s value in European trials?

Focus on health economic evaluation rather than clinical outcome assessment. Ensure your platform supports QALY calculations with country-specific preference weights, and coordinate with HTA bodies early in protocol development.

What’s the most efficient EQ-5D implementation approach?

HTA-optimized implementation (12-16 weeks) provides the highest return on investment by focusing on EQ-5D’s established strengths rather than attempting to overcome its regulatory limitations.

References

[1] Shaw, J.W., et al. (2024). A Review of the Use of EQ-5D for Clinical Outcome Assessment in Health Technology Assessment, Regulatory Claims, and Published Literature. The Patient. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11039499/

[2] Pickard, A.S., et al. (2007). Psychometric comparison of the standard EQ-5D to a 5 level version in cancer patients. Medical Care, 45(3), 259-263. Available at: https://pubmed.ncbi.nlm.nih.gov/17304084/

[3] Sampson, C. (2022). NICE and the EQ-5D-5L: Ten Years Trouble. PharmacoEconomics – Open, 6, 5-8. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC8807740/

[4] Ciani O, et al. (2023). The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022. Pharmacoeconomics, 41(11), 1411-1426. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC10627987/

[5] NICE. (2019). Position Statement on Use of the EQ-5D-5L Value Set for England (updated October 2019). Available at: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/technology-appraisal-guidance/eq-5d-5l

[6] Haute Autorité de Santé (HAS). (2020). Choices in Methods for Economic Evaluation. Available at: https://www.has-sante.fr/jcms/r_1499422/en/methodological-guide-for-health-economic-evaluation

[7] Devlin, N., et al. (2018). Valuing health-related quality of life: An EQ-5D-5L value set for England. Health Economics, 27(1), 7-22. Available at: https://pubmed.ncbi.nlm.nih.gov/28833869/

[8] Janssen, M.F., et al. (2013). Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups. Quality of Life Research, 22(7), 1717-1727. Available at: https://pubmed.ncbi.nlm.nih.gov/23184421/

[9] EuroQol Research Foundation. (2023). EQ-5D-5L User Guide. Available at: https://euroqol.org/information-and-support/euroqol-instruments/eq-5d-5l/

[10] FDA. (2024). Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Available at: https://www.fda.gov/media/77832/download

Comments closed

ePRO, eCOA 101: Everything You Need to Know About ePRO and eCOA

July 31st, 2025 by

What is eCOA?

Electronic Clinical Outcome Assessment (eCOA) represents the digital transformation of patient outcome measurement in clinical trials. Rather than relying on traditional paper forms, eCOA technology encompasses all electronically captured clinical outcomes data, fundamentally changing how trials collect and manage patient-reported information.

The shift from paper to digital has revolutionized clinical trial data collection, creating new opportunities for real-time monitoring and improved data quality. Modern electronic data capture systems integrate with eCOA platforms to create comprehensive clinical data ecosystems supporting both regulatory submissions and real-world evidence generation.

Understanding ePRO Within the eCOA Framework

Electronic Patient Reported Outcomes (ePRO) represents the patient-centric component within the broader eCOA framework. While these terms are often used interchangeably, ePRO is actually one of four distinct assessment types within the eCOA ecosystem:

  • ePRO (electronic Patient Reported Outcomes): Patient-reported symptoms, quality of life measures, and treatment experiences
  • eClinRO (electronic Clinician Reported Outcomes): Healthcare provider assessments and clinical observations
  • eObsRO (electronic Observer Reported Outcomes): Caregiver or family member observations, particularly important in pediatric or cognitive studies
  • ePerfO (electronic Performance Outcomes): Objective measurements captured through digital tools and devices

ePRO has gained particular prominence in patient journey optimization due to its direct connection to patient experiences and regulatory emphasis on patient-centered drug development. Decentralized clinical trials increasingly rely on ePRO data to capture patient experiences outside traditional clinic settings.

The Implementation Reality: Beyond Technology

eCOA implementation involves significantly more complexity than deploying a simple electronic survey. The process requires careful coordination of regulatory compliance, intellectual property management, and operational planning across multiple stakeholders.

Regulatory Framework: Regulatory agencies continue emphasizing electronic data collection approaches in clinical trials, with updated guidance supporting eCOA implementation. The FDA defines Clinical Outcome Assessments as measures that describe or reflect “how a patient feels, functions, or survives,” encompassing the four eCOA categories [FDA 2024][1]. The industry has responded with remarkable growth – the global eCOA solutions market reached $1.94 billion in 2024 and is projected to grow at 16.1% annually to $4.78 billion by 2030 [MarketsandMarkets 2024][2].

Intellectual Property Management: Many clinical trials utilize copyrighted assessment instruments that require specific licensing agreements. These instruments often carry usage restrictions and approval processes that can significantly impact implementation timelines and platform selection decisions.

System Integration Requirements: eCOA platforms must integrate with existing clinical trial infrastructure including EDC systems, clinical trial management systems, and regulatory submission processes. This integration requires sophisticated technical architectures and security protocols that meet clinical research standards.

Data Integrity and Compliance: Clinical trials require comprehensive audit trails, electronic signatures, and data lineage capabilities that support regulatory inspections. Organizations must ensure their eCOA platforms integrate with electronic consent processes and maintain data integrity throughout the study lifecycle.

BYOD vs. Provisioned Devices: Strategic Considerations

The choice between Bring Your Own Device (BYOD) and sponsor-provisioned device strategies represents a critical implementation decision with implications for patient experience, data quality, and operational complexity.

Provisioned Device Approach

Sponsor-supplied devices offer controlled environments with standardized hardware, operating systems, and security configurations. This approach provides consistency across all participants but introduces logistical challenges including device distribution, technical support, and patient training requirements.

BYOD Strategy Considerations

BYOD approaches leverage patients’ existing smartphones and tablets, potentially improving engagement through familiar interfaces and integration into daily routines. However, BYOD implementation requires careful attention to device variability, security protocols, and data equivalency validation across different platforms and operating systems.

BYOD adoption is accelerating rapidly, driven by cost-effectiveness and patient familiarity with personal devices. Research demonstrates the importance of patient-centered design and user experience for successful eCOA implementation, with electronic methods showing superior compliance compared to traditional paper-based approaches [Clinical Leader 2024][3]. Organizations considering BYOD strategies should evaluate current regulatory expectations and validation requirements for their specific study contexts.

Licensing and Validation Considerations

Copyright and licensing management represents one of the most complex aspects of commercial eCOA implementations, particularly for studies utilizing established clinical assessment instruments.

Licensing Requirements: Many clinical outcome assessments are copyrighted materials requiring study-specific licenses for electronic deployment. These licensing processes often involve multiple stakeholders and can require technical documentation, translation reviews, and approval workflows that extend implementation timelines.

Validation Processes: Electronic implementations of established instruments may require validation studies to demonstrate equivalence with paper-based versions. These studies ensure that electronic formats maintain the measurement properties and clinical validity of the original instruments.

Multi-Language Considerations: Global clinical trials require linguistic validation processes that extend beyond simple translation. These processes involve cultural adaptation, cognitive testing, and formal validation studies to ensure conceptual equivalence across different populations and languages.

Implementation Planning and Timeline Management

Successful eCOA implementation requires realistic planning that accounts for the various regulatory, technical, and operational requirements involved in electronic data collection deployment.

Timeline Variables: Implementation schedules depend on multiple factors including study complexity, regulatory requirements, licensing needs, translation requirements, and organizational readiness. Early identification of these variables helps establish realistic project timelines and resource allocation.

Change Management: Modifications to electronic systems after initial deployment often require coordination across multiple study components including visit schedules, data transfer processes, site training materials, and regulatory documentation. Planning for potential changes during the implementation process helps minimize disruption to ongoing studies.

Optimization Opportunities: Organizations with established eCOA capabilities may achieve implementation efficiencies through standardized processes, pre-validated instrument libraries, and streamlined approval workflows. These approaches can provide time savings when appropriate for specific study requirements.

Patient Engagement and Data Quality Benefits

The transformation from paper-based assessments to electronic systems addresses fundamental challenges in clinical data collection, particularly patient compliance and data accuracy.

Compliance and Completion Rates: Research has demonstrated that patients are significantly less compliant with paper diaries than previously assumed, with studies showing higher completion rates and more accurate data capture with electronic methods [Stone et al. 2002][4]. Electronic systems provide real-time data validation, immediate feedback to patients, and automated reminders that improve protocol adherence.

Patient-Centered Design: Modern eCOA platforms prioritize intuitive user interfaces and patient-facing technology improvements that accommodate diverse patient populations, including considerations for age, technical literacy, and accessibility requirements. This patient-centric approach recognizes that patients are experts in their own experience and should be empowered to provide accurate, meaningful data.

Real-Time Data Quality: Electronic capture enables immediate data validation, range checks, and consistency monitoring that identifies potential issues before they impact study integrity. This real-time capability supports both patient safety monitoring and regulatory submission requirements.

Implementation Best Practices and Workflow

Successful eCOA implementation requires systematic planning that addresses both technical and operational considerations throughout the study lifecycle.

Pre-Implementation Planning: Effective eCOA deployment begins with comprehensive assessment of patient populations, study requirements, and operational capabilities. This includes evaluating patient technology access, site infrastructure, and regulatory requirements across all study regions.

User Experience Validation: Testing eCOA interfaces with representative patient populations ensures usability across diverse demographics and technology comfort levels. This validation process should include cognitive interviews and usability testing to identify potential barriers to completion.

Training and Support Infrastructure: Comprehensive training programs for both sites and patients, supported by accessible technical support, are critical for successful adoption. This includes developing multilingual support materials and establishing clear escalation procedures for technical issues.

Data Integration and Monitoring: eCOA platforms must integrate seamlessly with electronic data capture systems and provide real-time monitoring capabilities that support both operational oversight and patient safety monitoring.

Technology Evolution and Future Considerations

Emerging Technologies: The eCOA field continues evolving with advances in mobile technology, wearable devices, and digital therapeutics integration. Organizations are increasingly exploring how these technologies can enhance patient engagement while maintaining regulatory compliance and data integrity.

Regulatory Adaptation: As regulatory agencies gain experience with electronic data collection approaches, guidance continues evolving to address new technologies and implementation approaches. Staying current with regulatory expectations remains essential for successful eCOA deployment.

Industry Standardization: Professional organizations and industry consortiums continue developing best practices and standardized approaches that can improve implementation efficiency and reduce regulatory review timelines across the industry.

 

Looking to implement eCOA solutions for your clinical trials? Discover how Castor’s integrated eCOA platform combines regulatory compliance with patient-centered design to accelerate your clinical research objectives.

Frequently Asked Questions

What is the difference between eCOA and ePRO?

eCOA (Electronic Clinical Outcome Assessment) serves as the umbrella term for all electronically captured clinical outcomes data. ePRO (Electronic Patient Reported Outcomes) represents the patient-reported component within the eCOA framework, alongside eClinRO (clinician-reported), eObsRO (observer-reported), and ePerfO (performance-based) outcomes.

How long does eCOA implementation typically take?

Implementation timelines vary significantly based on study complexity, regulatory requirements, licensing needs, translation requirements, and organizational capabilities. Early identification of these factors and realistic project planning help establish appropriate timelines for specific study contexts.

What are the key considerations for BYOD vs. provisioned devices?

The choice depends on study requirements, patient populations, regulatory considerations, and operational capabilities. BYOD approaches may improve patient engagement through familiar interfaces, while provisioned devices offer controlled environments. Both strategies require careful attention to data quality, security, and regulatory compliance.

How do licensing requirements affect eCOA implementation?

Many clinical assessment instruments are copyrighted materials requiring study-specific licenses for electronic deployment. These licensing processes can involve multiple stakeholders and approval workflows, making early planning and stakeholder engagement important for realistic timeline management.

 

References

  1. U.S. Food and Drug Administration. (2024). Clinical Outcome Assessment (COA) Frequently Asked Questions. Available at: https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions
  2. MarketsandMarkets. (2024). Electronic Clinical Outcome Assessment Solutions Market Growth, Drivers, and Opportunities. Available at: https://www.marketsandmarkets.com/Market-Reports/ecoa-solutions-market-87857774.html
  3. Clinical Leader. (2024). The Rise of Electronic Clinical Outcome Assessments (eCOAs) in the Age of Patient Centricity. Available at: https://www.clinicalleader.com/doc/the-rise-of-electronic-clinical-outcome-assessments-ecoas-in-the-age-of-patient-centricity-0001
  4. Stone, A.A., et al. (2002). Patient non-compliance with paper diaries. BMJ, 324(7347), 1193-1194. Available at: https://www.bmj.com/content/324/7347/1193

Comments closed

Why eCOA Still Fails in Clinical Trials: Practical Strategies to Fix Baseline Data Problems

July 18th, 2025 by

Electronic COAs were meant to protect data quality and capture the patient voice. But missing baseline data, poor site preparation, and unrealistic timelines continue to break studies. In a frank discussion hosted by Castor, Derk Arts (Castor), Katja Rudell (Kielo Research), and Ari Gnanasakthy (RTI Health Solutions) unpacked where the breakdowns really happen — and how to address them practically.

“When you have 40% missing at baseline, you pretty much lost the study.” Ari Gnanasakthy

What Goes Wrong, Repeatedly in eCOA Clinical Trials

For over 20 years, eCOA has been positioned as a fix for data quality in clinical trials. But under pressure to launch quickly, the fundamentals still fail. Platforms aren’t validated in time. Sites are unprepared to train patients. Devices get stuck in customs. Sponsors overload studies with endpoints without checking whether sites can realistically execute them.

Ari gave a stark example: nearly half of baseline data lost because provisioned devices didn’t arrive on time. That kind of problem can destroy confidence in the entire trial, yet it keeps happening because sponsors focus on checklists rather than operational readiness.

“Defaulting to ePRO is fine. But when execution fails, confidence collapses.”

eCOA Organizational Friction and Clinical Operations

Many of these issues have little to do with the technology itself. They are organizational. Procurement departments pick eCOA vendors without involving scientific leadership. Clinical teams don’t leave enough time between protocol sign-off and first-patient-in. Multiple business units push conflicting priorities: commercial, HTA, regulatory, patient engagement — all pulling studies in different directions.

Katja noted even well-designed eCOA systems collapse when no one is coordinating translations, site training, device shipments, and ongoing data monitoring. When those hand-offs fail, secondary endpoints suffer, leaving massive data gaps no statistician can fix after the fact.

“Different teams chase different goals. That’s how data gets lost.” Katja Rudell

Practical Steps to Simplify eCOA Implementation

Derk challenged the group to question the myth of unavoidable complexity. In industries like aviation, change and surprises are planned for systematically. Clinical trials tolerate known failure points again and again — customs delays, missing devices, untrained staff — and act surprised every time.

The panelists pointed to several actionable ways forward:

Sponsors should also push vendors for true contingency planning. There is no excuse for having no Plan B in a study with critical endpoints.

“We act surprised every time these issues happen. That’s on us.” Derk Arts

A Path to Consistency and Patient-Reported Outcomes Success

No one suggested eCOA is fundamentally flawed. Quite the opposite: when done well, it supports high-quality patient-reported outcomes that add enormous value to a study. Ari reminded the audience that many trials do succeed — but those that fail, fail for predictable, preventable reasons.

Sponsors, CROs, and vendors should share lessons across studies, build repeatable playbooks, and train site staff continuously. Patients will only deliver quality data if their participation is practical and realistic — no matter what the protocol says on paper.

“If you expose patients to a product, you owe it to them to ask how they feel about it.” Katja Rudell

Key Takeaways

Watch the full webinar on-demand here for unfiltered, practical insights you can apply to your next clinical trial.

Comments closed

Building Biotech: From Science to Scale – Strategic Lessons from the Frontline

May 28th, 2025 by

Biotech isn’t for the faint-hearted. As Derk Arts, CEO of Castor, and Professor Thomas Wurdinger discussed in their recent LinkedIn Live session, building a successful biotech company demands more than just groundbreaking science. Their conversation, titled “Building Biotech: From Science to Scale,” peeled back the layers on what truly drives success in early-stage biotechs. Spoiler: it’s less about having the best data and more about narrative, execution, and alignment.

Biotech, they argue, is the survival of the funded. It’s a terrain where the loudest story often drowns out the best science. Wurdinger’s own journey underscores this paradox. From his days as an RNA researcher to founding ThromboDx—a diagnostics company acquired by Illumina—and watching it evolve into Grail, his career exemplifies the rare but critical blend of academic depth and commercial savvy.

“Having the best data doesn’t guarantee funding, while poor data can often get you funded fast.”— Thomas Wurdinger

One of the most telling themes from the conversation is how market sentiment frequently trumps scientific merit. The Illumina-Grail case highlights this reality. Regulatory friction, misaligned expectations, and timing can vaporize billions in value overnight. In such a volatile landscape, a great idea needs more than validation; it needs strategy.

Wurdinger’s transition from the lab bench to the boardroom reveals the critical early decisions that separate promising biotechs from perishable ones. His threefold advice? First, founders must seek strong mentors who can help navigate intellectual property (IP), licensing, and fundraising. Second, never sign licensing or investment documents without independent legal counsel—no matter how friendly the university seems. And third, founders need brutal self-awareness: not everyone is meant to be a CEO, and clinging to titles can stall progress.

The tension between data quality and funding viability also took center stage. Many startups, especially those emerging from academic labs, struggle to convince VCs because their innovation doesn’t fit into the typical biotech investment playbook. Unlike therapeutic programs with clear regulatory and clinical pathways, platform or diagnostic companies must often invent their own roadmap—and articulate that roadmap convincingly to investors.

“Pride is your worst enemy when you’re in a startup.”— Thomas Wurdinger

This is where storytelling matters. Investors aren’t just betting on data. They’re betting on a vision, a team, and a well-crafted narrative that explains why now is the time, why this team is the right one, and why this solution matters. That’s why Wurdinger’s investment fund includes a filmmaker as one of the partners—to help founders construct that narrative arc. Because in biotech, your pitch deck is more than a slide show. It’s the first act of a story that investors must want to see through to its final scene.

While robust data underpins credibility, it’s often not the first thing investors see. Especially in early-stage funding, decisions are made based on the team, the problem-solution fit, and the ability to scale. Once a startup progresses, though, clinical readiness becomes critical. This includes preclinical validation, manufacturing scalability via CDMOs or CROs, and FDA registration planning. Without these, clinical trials are non-starters—and timelines slip fast.

Explore Castor’s tools for decentralized and hybrid trials

Wurdinger also offered pragmatic insight into fundraising phases. Many companies bridge the early-stage “valley of death” with government grants (like Eurostars) and local loans. Family, friends, and early believers play a crucial role, albeit a risky one. But to attract serious venture capital, companies need credible leadership, not just science. A seasoned CEO, clear go-to-market strategy, and defensible IP position are often the deciding factors.

Team-building was another recurrent theme. Founders should avoid perfectionism when assembling their leadership team. Instead, they need people who are aligned, resilient, and pragmatic. Equity dilution is not failure; it’s the price of momentum. The value lies in execution, not in retaining 100% of a stalled startup.

“You can’t get the best people in when you’re a startup and basically a nobody in startup land.”- Thomas Wurdinger

For first-time founders, Wurdinger left a final checklist: seek out mentors who challenge you; retain your own legal counsel; build your story before your data; and hire for your blind spots. Passion fuels the journey, but structure sustains it. No matter how disruptive your science, startups don’t scale themselves. They are built, step-by-step, through smart strategy, clinical readiness, and investor trust.

Platforms like Castor play a pivotal role here. As Wurdinger and Arts both noted, accelerating clinical operations through tech-enabled solutions is one of the few defensible edges in an increasingly competitive biotech ecosystem. With modern EDC systems, decentralized trial capabilities, and scalable workflows, Castor helps bridge the gap from hypothesis to human evidence.

The path from science to scale is long, but it’s navigable. With the right story, the right data, and the right team, even the most complex ideas can become transformative companies.

Comments closed

From Hype to Health: What Sword Health Got Right About Evidence

June 26th, 2025 by

Most digital health companies struggle to prove they work. Sword Health didn’t. In this conversation, Fernando Correia (CMO, Sword) explains what they did differently—and why it mattered.

This article is based on a live webinar between Fernando and Castor CEO Derk Arts. You can watch the full conversation on-demand here: Watch the webinar.

Start with the Problem, Not the Pitch

MSK conditions affect 1 in 2 Americans. Sword saw that early and focused on building programs for large, well-defined problems—not niche use cases. They didn’t start with technology. They started with what clinical guidelines already said worked: exercise, education, and behavior change. Then they asked: how can we digitize and scale this without losing impact?

Proof Beats Hype

Back in 2015, digital care wasn’t taken seriously. Sword ran their first RCTs on paper to prove they could match in-person PT. It took three years to publish those first results. They knew they had to show outcomes before anyone would pay attention.

As they scaled, Sword invested in real-world data collection. They worked with product teams to embed validated outcomes into the user flow. They collected baseline and follow-up data at scale. Today, they have datasets with over 200,000 patients—including the largest real-world sample of low back pain patients in digital care.

Not Just a Tech Stack

Sword didn’t just build an app. They built a care delivery model—with humans, hardware, and AI. Their product includes motion capture, a CBT module, and Phoenix, an AI assistant. Clinicians manage 600+ patients with tech that flags risks and adapts plans. The goal: quality care at scale.

RCTs + RWE = Reimbursement

Sword’s trials showed they could match or outperform in-person PT—even when time and intensity were equal. Their real-world evidence showed sustained outcomes and lower healthcare utilization. That data got them contracts with payers and employers. Today, over 13 million people in the U.S. have access to Sword through their benefits.

Why Castor?

When Sword outgrew paper and spreadsheets, they needed a system their clinical team could own. Castor’s EDC let them build and run trials without code. During the pandemic, they ran two U.S.-based RCTs on Castor. The platform helped them publish faster, work more independently, and meet quality standards without bloated CRO costs.

Takeaways for Digital Health Teams

Sword didn’t just survive the hype cycle. They outlasted it. Evidence was the reason.

👉 Watch the full webinar on-demand

Comments closed

How a 3-Person Team Got to Phase 3 — Without the Overhead

June 26th, 2025 by

A Hands-On Approach to Global Trial Execution

Gameto is a 20-person biotech. Their clinical operations team? Just three people. Yet that trio has designed and run nine studies across Peru, Mexico, Australia, and the United States—on their own infrastructure, without a big-box CRO, and without hiring dedicated data managers. They’re now in Phase 3 in the U.S. and already have commercial access in several countries.

What makes this story worth your time is how little was outsourced. Gameto didn’t hand off trial setup to consultants. They trained embryologists during live egg retrievals, used existing site relationships for implementation, and configured studies directly in Castor. Fast, focused, and regulator-ready.

“You’d be surprised what you can accomplish when there’s no other choice.”

— Sabrina Piechota, Clinical Ops, Gameto

Study Build in Weeks, Not Months

One randomized trial in Peru went from protocol to go-live in three weeks—in Spanish. It covered patient demographics, hormone labs, embryology results, pregnancy data, adverse events, image uploads, and randomization. The build came from Castor’s documentation and helpdesk—no special training, no delays.

“We don’t have six months to set up a database. We have three weeks.”

— Christian Kramme, CSO, Gameto

Data That Passes FDA Review

A 38-patient dataset—30 Fertilo, 10 control—moved the product straight into FDA Phase 3. Clean audit trails and rapid CRF versioning kept regulators comfortable.

“We’re constantly learning, so the platform had to let us adjust on the fly without losing quality.”

— Christian Kramme

Localization Without the Bottleneck

Modular CRFs with multilingual support let the team reuse core forms while adding local fields. Most issues were spotted through direct CRF review and fixed in real time—no extra headcount required.

A Global Head-to-Head Study, Run Lean

Next, Gameto will compare Fertilo to conventional IVF in Europe, Australia, the Middle East, and Southeast Asia. Same three-person core team, same platform, bigger impact.

“We’re not trying to build a giant apparatus. We want to stay nimble, stay close to our data, and scale smart.”

— Christian Kramme

Long-Term Follow-Up Built In

Maternal safety and two-year infant development metrics are already embedded in the registry. Patients complete milestone questionnaires every six months, feeding directly into the Castor database.

Watch the Full Conversation

This article distills key points from the fireside chat between Derk Arts (Castor CEO), Christian Kramme (Gameto CSO) and Sabrina Piechota (Gameto, Embryology Department Manager). For the complete discussion—including audience Q&A—watch the on-demand webinar here:

How Gameto’s Team Built a Phase 3 Trial Engine from the Ground Up (On-Demand)

What Larger Teams Can Learn

Speed is only half the story; precision is the other. By keeping data close to the scientists and trusting a flexible EDC, Gameto shows that lean execution can satisfy regulators and accelerate timelines. For sponsors tired of bloated vendor chains, this is proof that smaller, smarter teams can win.

Comments closed

The Catch-22 of eConsent: The Missed Opportunity for Improved Clinical Trials

March 13th, 2025 by

eConsent technology is often praised for its potential to revolutionize clinical trials, yet it remains underutilized. The promise is clear: better comprehension leads to better satisfaction, retention, and protocol adherence. But the reality is much bleaker. Many implementations fail to deliver on this promise because they treat eConsent as a digital version of paper forms rather than as a transformational tool. This article explores the barriers holding eConsent back, backed by evidence from scientific literature, and proposes actionable solutions.

Why eConsent Matters: The Evidence

Multiple studies have demonstrated that interactive eConsent tools enhance patient comprehension compared to traditional methods. Taylor et al. (2021) showed that video-based consent interventions significantly improved participants’ understanding of trial concepts compared to standard consent forms. Their randomized trial across six clinical studies found:

“Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process.” (p = 0.020).

Moreover, Glaser et al. (2020) highlight that 85% of interactive, teach-back-based digital interventions successfully improved comprehension outcomes. They concluded:

“Interactive interventions, particularly with test/feedback or teach-back components, appear superior.”

Retention is another critical metric tied to eConsent. Skea et al. (2019) emphasize that participants drop out when they don’t feel adequately informed or when trial demands are misaligned with their expectations:

“Initial decisions to participate may not have been fully informed, leading to mismatched expectations and eventual attrition.”

These findings align with broader educational research demonstrating that interactivity and multimedia boost knowledge retention. For example, multimedia learning theory shows that combining visuals, text, and interactivity engages multiple cognitive pathways, enhancing understanding.

The Catch-22: Barriers to eConsent Adoption

Despite these proven benefits, eConsent remains stuck in a vicious cycle:

“The term ‘eConsent’ is often misunderstood, with many platforms offering only weak ‘design’ functions, which do not fulfill the full promise of digital tools.”

“Current practices often fail to define adequate patient comprehension and to ensure its assessment as part of the informed consent process, leading to frustration among sites.”

Breaking the Cycle: Unlocking eConsent’s Full Potential

  1. Example 1: Incorporating Interactive Features
     Taylor et al. (2021) demonstrated that video-based eConsent significantly improved satisfaction and understanding. If we give patients a short a video explaining key trial concepts, followed by an interactive quiz, we have already made real progress. This approach not only improves comprehension but also creates an audit trail for compliance.
  2. Example 2: Leveraging Educational Theory
     Studies on digital learning suggest that chunking information into bite-sized pieces and using visual aids enhances retention. A trial sponsor could use animated videos to explain randomization or potential side effects, coupled with glossary tools to define medical terms. Such tools could reduce dropout rates and enhance patient confidence.
  3. Example 3: Quantifying ROI
     Consider a large, global trial where dropout rates are reduced by just 5% through better eConsent. This could save millions in recruitment and operational costs. To encourage adoption, sponsors should calculate and share these savings, framing the initial investment as a long-term cost-saving measure.

Finally: just doing the right thing

Beyond the financial and operational arguments, eConsent represents an ethical obligation. As Pietrzykowski and Smilowska (2021) emphasize:

“The informed consent process actually leads to patients’ full comprehension of what they are consenting to. Unless this assumption is demonstrably true, the ethical viability of current medical experimentation practice is seriously flawed.”

This is also where I feel strongly. We are submitting patients to incomprehensibly long consent forms, knowing that comprehension will be low, but at least we’ve covered our legal bases.

Using multimedia and personalized tools isn’t just about better trials—it’s about respecting participants’ autonomy. When patients fully understand what they’re agreeing to, every stakeholder reaps the rewards.

To summarize, we must:

It’s time to move beyond treating eConsent as a checkbox and realize its full potential. The technology is ready—now the industry must commit to using it to create better, more ethical, and more successful clinical trials. Let’s break the cycle.

References

  1. Taylor et al. (2021). Randomized comparison of two interventions to enhance understanding during the informed consent process for research. Clinical Trials, 18(4), 466–476. doi:10.1177/17407745211009529
  2. Glaser et al. (2020). Interventions to improve patient comprehension in informed consent for medical and surgical procedures: An updated systematic review. Medical Decision Making, 40(2), 119–143. doi:10.1177/0272989X19896348
  3. Skea et al. (2019). Exploring non-retention in clinical trials: A meta-ethnographic synthesis of studies reporting participant reasons for drop out. BMJ Open, 9(6), e021959. doi:10.1136/bmjopen-2018-021959
  4. Vanaken et al. (2024). Effective eConsent strategies for every study: Utilizing the eConsent fit-for-purpose study framework. Applied Clinical Trials. Available online.
  5. Pietrzykowski & Smilowska (2021). The reality of informed consent: Empirical studies on patient comprehension—Systematic review. Trials, 22(1), 57. doi:10.1186/s13063-020-04969-w

Comments closed

Measuring the true patient experience in Cancer Trials with eCOA / ePRO

March 22nd, 2024 by

Our recent webinar featuring PRO expert Ari Gnanasakthy, RTI Health Solutions, and Derk Arts, CEO & Founder, Castor, sheds light on the complexities and advancements in measuring PROs, drug tolerability, and quality of life in cancer trials. Here, we distill the insights shared and explore the implications for future research.

Cancer studies are not what they used to be

Derk and Ari kicked off their conversation by discussing how cancer research is getting more and more complex and with this ever-evolving landscape, a focus on patient-reported outcomes (PROs) and clinical outcome assessments (COAs) has never been more critical. With the emergence of innovative treatments such as plasma-derived therapies, CAR-T therapies, reductions in chemotherapy cycles, and a surge in novel oral medications, the shift towards more personalized and targeted therapies underscores the necessity to move beyond traditional PRO methodologies.

In this new era, a more patient-centric approach is needed, ensuring that treatment strategies not only combat the disease effectively but also offer real-time insights into treatment efficacy, patient well-being, tolerability, and quality of life (QoL).

“Let’s stop talking about patient reported outcomes, instead let’s talk about the patient experience and the ways we measure QoL within all the nuances of cancer trials.“

– Ari Gnanasakthy, RTI Health Solutions

Navigating the regulatory landscape

The webinar delved into the changing regulatory landscape for cancer trials, particularly for measuring PROs. As treatments like CAR-T cell therapy become more prevalent, capturing the authentic patient journey has become more crucial for understanding both efficacy and safety. Regulatory bodies are increasingly emphasizing the importance of real-world evidence, pushing for a more comprehensive view of treatment impacts. This shift necessitates meticulous planning in data collection, not only to meet regulatory approval requirements but also to address the downstream needs of payers. Having this dual focus ensures that the collected information serves both immediate regulatory purposes and future payer evaluations, facilitating a smoother transition from clinical approval to market access. With the rise of personalized and targeted therapies, the reliance on outdated PRO methodologies is no longer viable. Clinical trial design needs to reflect a balance between scientific rigor and patient-centricity, ensuring research outcomes are both scientifically valid and meaningful to patients’ lives.

Who says the drug is tolerable?

The Patient. A critical aspect of the discussion between Ari and Derk centered on the concept of measuring treatment tolerability and QoL within cancer research. The conversation highlighted a need to shift perspectives, with emphasis on understanding how tolerability influences patient adherence and overall treatment outcomes. Ari emphasized the importance of viewing tolerability through a comprehensive lens and throughout treatment cycles.

“Tolerability is not something that can be measured at the beginning of each cycle when patients are reasonably healthy. Tolerability is something that needs to be measured when patients are having issues and when the drug is at peak, during cycles…probably on a weekly basis.”

– Ari Gnanasakthy, RTI Health Solutions

But how do we consistently measure something so subjective in a scientific way? Tolerability is not just one measure but a number of elements that need to be considered, including safety data, treatment data and PROs (like physical and role function, side effect burden or even hair loss). It is clear we need to consider both the physical and psychological nuances of patient experiences when assessing treatment tolerability.

Elements of treatment tolerabilityWhat does the future hold for ePRO?

Finally, Derk and Ari spent time looking ahead at how the role of technology and ePRO in cancer research is expected to expand. Wearables, BYOD (Bring Your Own Device) strategies and advanced scheduling for data collection will play pivotal roles, enabling real world data collection that reflects the true impact of cancer treatment on patients’ lives.

This digital-first approach is anticipated to improve data quality and drive more patient engagement. By engaging patients through their own smartphones and leveraging technology they are familiar with, clinical trials can more accurately measure the true patient experience, thereby improving participation and adherence. Additionally, ePRO technology offers solutions to challenges around data integrity and overcoming the “parking lot effect,” where responses may be influenced by the immediate environment of data collection. This evolution marks a pivotal step towards more patient-centric research and ultimately better outcomes.

“It’s now clear that we’re dealing with three layers of data. Initially, we have the core data that has been the focus for the past two decades. Added to this are scheduled QoL and tolerability data. The final layer encompasses wearable and ad hoc data, enriching our understanding of tolerability. This stratified approach presents a significant opportunity to enhance patient outcomes.”

– Derk Arts, Castor Founder & CEO

And, from the sponsor side, it’s imperative to consider the influence of Quality of Life (QoL) and tolerability measures on the drug’s value proposition. For sponsors, overlooking this aspect could lead to a significant gap in their value proposition.

The single line item from the FACT-G questionnaire, GP5, which asks patients if they are “bothered by side effects of treatment,” has demonstrated a strong predictive value for both patient dropout and disease progression when patients report being troubled by side effects. This underscores the importance of integrating patient-centric measures into clinical trial design and evaluation to enhance patient retention and treatment outcomes.

Getting started with Castor eCOA / ePRO

To deepen the understanding of eCOA / ePRO technology for sites and sponsors, and to ensure fast study builds, Castor welcomes study teams to explore our eCOA / ePRO platform by offering early access, and allowing them to personally navigate the patient experience. Our comprehensive onboarding process and dedicated customer support play a pivotal role in this commitment. Additionally, we provide the option to work with synthetic data upfront, offering a proactive approach to risk mitigation.

At the heart of our platform is a patient-centric approach, designed to significantly improve the trial experience for participants. By prioritizing the patient perspective, we aim to enhance engagement and collect valuable real-world data. This data is crucial for gaining insights into treatment effectiveness, patient well-being, tolerability, and quality of life, in the ever changing landscape of cancer research.

For more information, watch our on-demand webinar:
eCOA / ePRO and Cancer Research – Measuring the true patient experience

Follow us on LinkedIn: Castor

Learn more about Castor eCOA / ePRO

Comments closed

The Place of COAs / PROs in the Future of Healthcare

March 9th, 2024 by

Over recent decades, we’ve witnessed a pivotal shift in the global healthcare landscape. As chronic conditions have become more prevalent, nations worldwide have been reevaluating their healthcare delivery models, moving away from traditional fee-for-service models towards a more outcomes-focused approach. Both governments and private payers are now pondering a critical question: “How can we reimburse healthcare providers based on the positive outcomes for patients, rather than just for the services they provide?”

Value-Based Care

Value-Based Care (VBC) programs represent a transformative approach in the healthcare industry, aimed at improving patient outcomes, enhancing care quality, and reducing healthcare costs. Unlike traditional fee-for-service models, which reimburse healthcare providers based on the quantity of care services delivered, VBC focuses on rewarding providers for the quality and effectiveness of care they provide to their patients. This model aligns financial incentives with patient outcomes, encouraging healthcare providers to offer care that is both efficient and tailored to the individual needs of patients.

The impact of VBC on the healthcare ecosystem is multifaceted. Firstly, it prompts a shift in the focus of healthcare delivery from treatment to prevention and patient wellness. By incentivizing positive patient outcomes, VBC encourages providers to invest more in preventive care measures, chronic disease management, and holistic approaches to patient health. This can lead to a decrease in hospital readmissions, fewer unnecessary medical procedures, and overall, a more sustainable healthcare system.

Secondly, VBC fosters collaboration among healthcare providers. Since the model rewards the improvement of patient outcomes across the continuum of care, it encourages different providers to work together more closely. Hospitals, primary care physicians, specialists, and even non-medical support services are motivated to share information and coordinate care more effectively, ensuring that patients receive the right care at the right time.

Patient-Reported Outcomes (PROs) play a crucial role in the success of VBC programs. PROs are direct reports from patients about how they feel in relation to a health condition and its therapy, without interpretation of the patient’s response by a clinician or anyone else.

This information is invaluable because it provides insights into the patient’s perspective on their health status, quality of life, and the effectiveness of treatments.

In the context of VBC, PROs help to ensure that care delivery is genuinely patient-centered, enabling healthcare providers to tailor their interventions to meet the specific needs and preferences of each patient.

PROs contribute to the measurement and assessment of healthcare outcomes, which is central to VBC. By incorporating PROs into their assessment criteria, VBC programs can use this data to evaluate the effectiveness of care from the patient’s viewpoint. This ensures that healthcare interventions not only achieve clinical objectives but also improve the quality of life for patients. Consequently, PROs are essential for the continuous improvement of healthcare services, guiding providers towards interventions that offer the greatest benefit to patients’ health and well-being.

PROs in Clinical Trials

When life sciences companies present data from clinical trials that include PROs, they provide a more comprehensive picture of a product’s benefits. This evidence is particularly persuasive to payers and healthcare providers, who are increasingly looking for treatments that offer meaningful improvements in patients’ lives, not just clinical metrics. For payers, such information supports decision-making related to coverage and reimbursement, as it aligns with the shift towards outcomes-based reimbursement models. Products that demonstrate a positive impact on patients’ quality of life are more likely to be covered and recommended within these frameworks, ensuring broader access for patients.

Similarly, healthcare providers, who are integral to the VBC ecosystem, are more likely to prescribe products that have been shown to enhance patient outcomes and satisfaction. In the context of outcomes-based care, providers are rewarded for delivering high-quality, patient-centered care, which includes prescribing treatments that patients are more likely to adhere to because of their favorable impact on quality of life. Therefore, clinical trial data enriched with PROs can significantly influence prescribing behaviors by highlighting the patient-perceived benefits of a treatment.

The inclusion of PROs in clinical trials signals to both payers and providers that a life sciences company is committed to understanding and addressing the holistic needs of patients. This can strengthen the company’s position in negotiations with payers and foster trust among healthcare providers, facilitating the successful adoption of new products.

PROs bridge the gap between clinical efficacy and patient experience, enabling life sciences companies to better meet the demands of the evolving healthcare landscape where the patient’s voice is increasingly central to care decisions.

Leveraging PROs in clinical trials is not just about enhancing the evidence base for new medical products; it’s about aligning these products with the fundamental principles of VBC and ensuring they meet the real-world needs of patients, payers, and providers. In doing so, life sciences companies can enhance the marketability of their products, ensuring they are well-positioned for successful adoption, coverage, and use in a healthcare environment that values and rewards meaningful improvements in patient health and quality of life.

For more information, follow us on LinkedIn: Castor | Kristen Harnack

Learn more about Castor’s eCOA / ePRO

References:

  1. CMS (Centers for Medicare & Medicaid Services). “Value-Based Programs.” [CMS website]
  2. Health Affairs. “Value-Based Care and Population Health: Opportunities and Challenges.”
  3. HHS (Department of Health & Human Services). “About the Affordable Care Act.” [HHS website]
  4. FDA (Food and Drug Administration). “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.” [FDA website]
  5. Journal of Managed Care & Specialty Pharmacy. “Patient-Reported Outcomes in Performance Measurement.”

Comments closed

6 Steps for Using eCOA / ePRO & Physician Surveys to Fulfill MDR PMCF

March 5th, 2020 by

To ensure ongoing regulatory compliance under the EU MDR, medical device manufacturers must demonstrate the safety and performance of marketed devices with data obtained through Post-Market Clinical Follow-up (PMCF) studies, which often include patient and physician surveys.

ePRO & Physician Surveys consulting graphic

When your PMCF plans include surveying physicians and other healthcare professionals or administering questionnaires to patients, physician survey forms or electronic Clinical Outcome Measures (eCOA) must be created to prepare for PMCF execution. The Regulatory Affairs Professionals Society (RAPS) described PMCF planning under EU MDR as a burden to manufacturers in an article dated 12 September 2019. To ease this burden, Castor’s technology can help automate PMCF execution so that the entire process can run smoothly and efficiently.

Physician Surveys

Depending on the type of device under PMCF scrutiny, electronic Physician Surveys may be the most effective route to submit relevant PMCF data on medical devices. This might be the case with devices used during certain surgical or endovascular procedures, or with devices that are implanted and require follow-up assessments with a healthcare provider (HCP). In such cases, HCPs may be invited to answer surveys focused on device clinical performance and safety outcomes in either a prospective or retrospective fashion using Castor-generated eCOA called a Clinician Reported Outcome (ClinRO) or Performance Outcome (PerfO) forms.

ePROs

Certain devices may benefit from a different approach in PMCF data collection. For example, devices intended for patient use such as insulin pumps or wearable devices may be better suited for ePRO or Observer Reported Outcome (ObsRO) forms, where patients themselves or their guardians submit PMCF data either prospectively or retrospectively. In such cases, patients/guardians can be recruited through marketing campaigns or via their providers to answer PMCF-tailored questionnaires in the form of ePROs/ObsROs.  

Just five steps can help you become compliant with PMCF requirements. Download our whitepaper to learn how.

How do you create Physician Surveys and ePROs?

With Castor, you can easily set up Physician Surveys or ePROs and send them to survey participants via email in a few, simple steps.

1. First, you will determine the structure of the survey by choosing the survey type as either a Physician Survey or an ePRO and by indicating the device type. For instance, you could identify your survey as an “Angioplasty device” as illustrated below:

PMCF_Structure

2. Second, you will type in the survey questions as in the example below: 

PMCF_Forms

Alternatively, you may be able to import existing survey samples from the Castor Form Exchange by downloading the survey structure and importing it into your PMCF study in Castor.

3. Once the survey structure and questions have been set up, a survey package should be created. You will be prompted to enter the sender’s name, the email subject, email text, and other survey properties as illustrated below:PMCF_survey_package

4. The survey package is now ready to be sent to participants. You can send your PMCF survey to a group of participants in bulk after importing their email addresses. Alternatively, you may send your PMCF survey to single participants. Surveys can be sent on a certain date or according to a specific follow-up schedule of your choice, for instance once every month for four months as illustrated below:

PMCF_survey_invitation

5. The respondent will receive an email with a unique link, which will redirect to the PMCF survey.  PMCF data collection will begin immediately as participants start responding, and their answers will be saved in real time in your Castor PMCF study. During PMCF data collection, you will be able to track the progress of your study at any time, as illustrated below.

Study Health Dashboard showing inclusions over time:PMCF_Study_Health_Dashboard

Study Health Dashboard showing record progress:PMCF_record_progress6. When the expected volume of PMCF data has been collected, you can export and analyze the data in your preferred format, for example SPSS, Excel, CSV, Restful API, HTML, or as a PDF.

Here is an example of an Excel export:

PMCF_excel_export

Here is an example of a PDF export for a single survey:PMCF_PDF

Here is an overview of survey response frequency:

In conclusion, when your PMCF plans require sending surveys to physicians or questionnaires to participants, physician survey forms or electronic Patient Reported Outcome (ePRO) forms must be created to prepare for PMCF execution. Castor helps you efficiently execute your PMCF plan through ePRO and electronic Physician Surveys. Contact our team to discuss how Castor’s technology can help you fulfill MDR and PMCF data requirements.

PMCF 5 Steps

No comments yet

ePRO: the electronic solution for patient reported outcomes – OLD

March 10th, 2017 by

Traditionally done on paper, surveys are a common way to collect data from study participants. Surveys are questionnaires that allow data to be collected from a pre-defined sample in a population [1].

Patient reported outcome measures, or PROMs, are a form of clinical outcome assessments (COAs) an easy method for measuring a patient’s health status or health-related quality of life. These capture data from moments in time through questionnaires which patients complete independently [2]. 

In the past, surveys have been administered on paper, which requires tedious administration and several logistics, and also poses a private health information security risk. However, due to digital technology, collecting ePROs (electronic Patient Reported Outcomes) securely is easier than ever. Patients can complete secure surveys sent via email, saving time, increasing engagement, and requiring less administration. At the moment, 23% of studies in Castor are using surveys through our eCOA / ePRO platform.

Benefits and Challenges of eCOA / ePRO

Online surveys are easy to distribute, however researchers should use tools designed and built for medical research, both for security and data compliance. A major benefit is a more efficient and streamlined workflow, equating to time saved for researchers and participants. Often, for example, travel time to clinic for data collection can be a barrier for participants and negatively impact the study, especially when researching rare diseases or small gene pools [3].

Surveys are cost effective, requiring minimal research power to reach people and collect data. With the correct electronic data capture (EDC) tool, researchers can send surveys directly from the system and do not need to import or copy data from paper. Well designed surveys will collect high quality relevant research data, but require careful crafting and evaluation of wording and questions [4].

As discussed above, questionnaires need to be well crafted to ensure they are valid and reliable. It is also important to ensure that the correct population sample is selected. As with all study designs, surveys can introduce bias as a result of poor responses or no-responses (response bias). 

Start collecting patient and clinician data in Castor ePRO today

How to create good surveys

As researchers, the challenging task lies in creating a well designed questionnaire that measures what it claims to measure ensuring that it is valid. External validity is important for the generalizability of the study, ie. are the inclusion or exclusion criteria properly defined, can the results be applied to a population [4]. And internal validity is related to the robustness of the study, ie. does it have sufficient statistical power, proper control groups, randomization and blinding [4]. And a reliable questionnaire that will produce consistent results upon repetition [1].

When generating a questionnaire, the questions can be close-ended or open-ended. With close-ended questions, researchers set the range of answers on a scale or a range of tick-boxes [1]. Open-ended questions or free text can enrich quantitative data, and researchers will want to plan in advance how this data will be analyzed [1].

Standardized questionnaires can also be used, see an example below of an EQ-5D Questionnaire from Kieran Bond of Aridhia [2]. These widely used forms ensure that a high level of validity and reliability is achieved throughout the research.

Example of an EQ-5D Questionnaire in Castor EDC

Reduce study build time and capture data from any source using Castor’s top-rated EDC system. Schedule a demo to learn how.

Using surveys for research in Castor eCOA / ePRO

Users can choose from tried and tested questionnaires shared by Castor users in the Castor Form Exchange. Standardized forms, such as the 36-Item Short Form Health Survey (SF-36) that measures quality of life, can be easily downloaded and re-used. Researchers can schedule surveys and create emailing schedules to distribute patient questionnaires on certain dates or according to a custom timeline. Data from the surveys can be in a variety of formats (SPSS, Excel, CSV).

Using encrypted email addresses, clinical data entry is combined with outbound survey invitations sent to study participants. And at the push of a button, researchers can send a questionnaire to hundreds of participants, monitor its status and see results directly in the study dashboard.

Click here to find out more about the Castor ePRO features or check out our webinar on how to build surveys in Castor.

Adding surveys in Castor EDC

Sources:

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC420179/
  2. http://www.aridhia.com/blog/building-trust-and-improving-participation-in-clinical-trials-using-innovative-electronic-data-capture-platforms/
  3. http://www.bmj.com/content/350/bmj.g7818
  4. http://www.bmj.com/about-bmj/resources-authors/bmj-right-journal-my-research-article

Demo Request

No comments yet

Evaluating “Bother” as a Component of Patient-Reported Outcomes in Clinical Studies

May 16th, 2024 by

Patient-reported outcome (PRO) instruments refer to multiple scales and questionnaires designed to collect patients’ personal feedback on their subjective experience in a clinical trial. A form of clinical outcome assessments (COAs), these validated tools are adaptable, suitable for broad application across diverse study populations or tailored to groups with particular diseases and conditions.

Depending on the research hypothesis and objectives, patient-reported outcome measures (PROMs) may serve as primary, secondary, or exploratory endpoints. PROMs have become increasingly important to clinicians, regulators, and payors for capturing patient-centered data about disease symptoms, side effects, functional outcomes, or health-related quality of life.1

Within the context of clinical trials, “bother” is intricately linked to PROMs. It encapsulates the adverse subjective experiences—ranging from mild discomfort to significant distress—that arise as a direct consequence of side effects or trial-related procedures.2

By incorporating bother questions as part of PROMs in clinical trials, researchers can better understand how patients perceive the impact of the condition or treatment on their daily lives. This information is crucial for evaluating treatment effectiveness, making informed clinical decisions, and improving patient care and quality of life.

In fact, the FACT-G questionnaire’s item GP5, which states, “I am bothered by side effects of treatment,” serves as an aggregate indicator of the cumulative burden of treatment-related toxicity. This particular item has been linked to a significant correlation with the overall quality of life, specifically the patient’s capacity to enjoy life.3 Additionally, bother as a PROM can help regulatory agencies and healthcare providers assess the overall benefit of a treatment from the patient’s perspective.3

Why Measure “Bother”?

When used as a PROM, patients are typically asked to rate the level of bother caused by specific aspects of their condition or the study procedures using standardized questionnaires or scales. These validated assessment tools cover a range of domains, such as pain, fatigue, emotional well-being, and physical functioning.

Patients may be asked to rate bother on a numerical scale (e.g., from 0 to 10) or using descriptive categories (e.g., none, mild, moderate, severe). These instruments can provide insights into the patient’s perspective, capturing data on how bothersome they find specific side effects, which might not be apparent through clinical measures alone.

Source: FACT-G (Version 4), FACIT.org.  

The wording and format of bother questions on a PROM will vary depending on the clinical trial focus and outcomes of interest3. Participants may be asked to rate the severity of specific symptoms, the frequency of certain events, or the impact of a therapeutic intervention on their daily lives. These questions can provide valuable insights into the acceptability and feasibility of the study intervention and help researchers make informed decisions about future clinical trials.

Incorporating “Bother” into Clinical Decision-Making

Patient tolerability is often assessed through measures of side effects or adverse events. However, the degree to which these side effects bother patients can vary widely. For some, mild side effects may be highly bothersome and impact their quality of life, leading to poor adherence or discontinuation of the treatment. In contrast, other patients might tolerate more severe side effects without significant bother, motivated by the drug’s benefits.2

Understanding the nuances of bother allows clinicians and researchers to make more informed decisions about treatment recommendations and drug development. It highlights the importance of a patient-centered approach in clinical trials, where patients’ subjective experiences are considered alongside traditional clinical endpoints. Understanding subjective feelings can lead to developing drugs that are effective and have tolerable side effect profiles, improving patient adherence and outcomes.

Example in a Drug Trial

In a hypothetical phase III trial of a new oncology medication, participants could be asked to complete a PROM that includes items on bother associated with side effects like nausea, fatigue, and neuropathy. By analyzing these data points, researchers can gain insights into the balance between the drug’s efficacy and the quality-of-life implications for patients. For instance, if a significant percentage of patients report high levels of bother from neuropathy, this might prompt further investigation into dose adjustments or supportive care options to mitigate this side effect.

Assessing “Bother” Across Cultures

Consideration of how the term bother is interpreted in other languages is needed when using these assessments in multi-center global clinical trials. Linguistic, cultural, psychometric, and clinical factors must be evaluated.4 Aligning instruments with the cultural context of diverse patient populations improves the validity and relevance of PROM data.4

PROMs and Payers

PROMs are often used to determine the value of an intervention. Health insurance companies and government healthcare programs use PRO data to determine the impact of treatment on a patient’s quality of life and functional status and make reimbursement decisions.

PROs are used in reimbursement decisions based on various factors: demonstrating clinical effectiveness, comparative effectiveness, determination of money for value, patient perspectives, and long-term outcomes. The increasing importance of PROs in reimbursement decisions reflects the shift toward value-based healthcare emphasizing patient-centered care. Data on the outcomes that matter most to patients are being used to allocate resources to treatments that provide the most meaning to patients.6

Conclusion

Patient-reported outcomes—such as the degree of bother—are pivotal in capturing the full spectrum of treatment impact in clinical trials. These subjective measures delve into the patient’s personal experience of discomfort or distress, which are not apparent through traditional clinical metrics such as lab results or physical assessments. By integrating these insights, we gain a deeper understanding of factors influencing patient adherence and tolerability to treatments.

Such outcomes are instrumental in shedding light on the patient’s journey—encompassing symptomatology, functional well-being, and satisfaction with the care received. Embracing a patient-centric model by incorporating bother as a metric not only aligns research with real-world experiences but also steers drug development towards therapies that resonate more closely with patient needs and lifestyle preferences.

In this endeavor, Castor’s eCOA / ePRO solution stands as a robust tool for investigators. It provides access to a suite of validated ePRO questionnaires and facilitates the creation of new ones, ensuring that patient voices are heard and valued in the quest for therapeutic innovation.

References

Comments closed

Unlocking FDA’s Vision for PRO Collection in RWE: Timing, Methods, and Insights

September 24th, 2024 by

The significance of patient-reported outcomes (PROs) in real-world evidence (RWE) studies is growing. As regulatory agencies like the FDA focus more on PROs impact on drug development and approvals, clinical trial teams must navigate the complexities of timing, methods, and data quality for these clinical outcome assessments (COAs).

Here we summarize the insights shared during a recent webinar hosted by Castor’s CEO, Derk Arts, featuring industry experts Ari Gnanasakthy (Principal Scientist, RTI Health Solutions) and Willie Muehlhausen (Co-CEO, Safira Clinical Research Ltd), where they discussed a new research paper entitled Critical Comments by Food and Drug Administration Reviewers on Patient-Reported Outcomes in Food and Drug Administration Regulatory Submissions (2018-2021).

FDA’s Expectations for PRO Data in RWE

A key takeaway is how critical the FDA’s recent guidance on PROs is for shaping both regulatory decisions and drug development. Ari Gnanasakthy emphasized how PROs reflect the patient experience, particularly in RWE settings, where traditional clinical endpoints may miss key treatment impacts.

The FDA’s guidance highlights the importance of when and how PRO data is collected, stressing that timing directly impacts data reliability.

“We’ve often seen that poor timing in PRO collection skews the real-world applicability of the data.” – Willie Muehlhausen

To ensure compliance, trial sponsors must align PRO methodologies with regulatory expectations early on, incorporating PROs in both pre- and post-marketing phases.

Timing and Methods: Getting it Right

Collecting PROs at the right time and using the right methods is crucial for maintaining data integrity. Timing isn’t just about capturing experiences at set intervals—it’s about ensuring the data mirrors real-world treatment conditions.

Ari elaborated: “If we collect PROs too early or too late, we risk either underestimating or overestimating the patient burden. FDA expects us to align with the patient’s journey.” Muehlhausen noted that digital tools like ePRO systems enable more dynamic data capture, which aligns with regulatory expectations.

The panel also stressed the importance of continually evaluating self-reported data for accuracy, requiring structured PRO methodologies, including careful frequency of assessments and question framing.

ePRO Fatigue: A Real Threat to Data Quality

ePRO fatigue is a significant challenge in PRO collection. Muehlhausen explained how the rise of digital PRO collection brings the risk of overwhelming patients with too many questionnaires, leading to lower compliance and subpar data.

To combat this, the experts recommended patient-centered design from the outset. “ePRO systems should be intuitive and designed with the patient in mind,” Muehlhausen said. Simplicity and ease of use are critical to keeping patients engaged, with automated reminders and user-friendly interfaces playing a key role in maintaining data consistency.

Tolerability Data: Differentiate Your Treatment in Competitive Markets

Beyond efficacy data, tolerability data is gaining importance. Gnanasakthy highlighted that the FDA is focusing more on how well patients endure treatment, especially for chronic conditions where long-term adherence is critical.

“The FDA’s focus on tolerability reflects a broader trend toward understanding the holistic patient experience. This isn’t just about ‘does the treatment work,’ but ‘can the patient live with it long-term?’” – Ari Gnanasakthy

Including tolerability data in RWE studies can help sponsors differentiate their products, especially in competitive markets with multiple treatment options.

Practical Solutions to Common Pitfalls in PRO Collection

The panel shared strategies to overcome common pitfalls in PRO collection. One key point was the need for agile study designs that allow for adjustments based on early PRO data trends. Gnanasakthy emphasized that “rigid study designs often fail to account for real-world variability in patient experiences.”

Other solutions included embedding PRO collection into patients’ daily routines to reduce disruption and fatigue. Muehlhausen stated, “We need to think about the patient’s lifestyle when designing PRO questionnaires. If the process fits into their day, we’re more likely to get high-quality, consistent data.”

The panel also recommended bring-your-own-device (BYOD) strategies, allowing patients to use their personal devices for PRO assessments. This increases convenience and lowers the barrier to participation.

FDA Guidance: A Blueprint for the Future

As the FDA refines its expectations for PRO collection, it’s clear that RWE will play an increasingly important role in regulatory decisions. The insights shared during the webinar provide a blueprint for aligning PRO strategies with FDA expectations while focusing on patient experience.

The experts agreed that the future of PRO data collection lies in seamlessly integrating technology with patient-centric design. Castor’s CEO, Derk Arts, closed the session by stressing the importance of ongoing collaboration between sponsors, patients, and regulators: “We must continue to innovate and adapt, keeping the patient at the heart of clinical trials.”

Conclusion: Innovate Your eCOA / ePRO Strategy with Castor

To stay ahead of the curve and ensure compliance with FDA guidelines, trial sponsors must adopt innovative PRO collection methods that prioritize patient engagement and data quality. As the industry continues to evolve, Castor offers cutting-edge eCOA / ePRO solutions that integrate seamlessly into your clinical trials, ensuring robust data collection and real-world relevance.

Comments closed

How to Incorporate Remote Technology in Your Next Medical Device Trial

November 19th, 2021 by

As decentralized clinical trials (DCTs) gain popularity and a nod of regulatory approval—the FDA just released updated guidance in January 2021—researchers are looking to incorporate remote technologies into medical device trials for a wide range of device classifications. For example, can a Class IIb device be managed entirely from home? Can at-home monitoring be used at all for a Class III device? This article explores current regulations for various classes of medical devices and how this will impact the need for participants to visit research sites throughout the trial.

The Benefits

There are numerous ways medical device trials can benefit from DCT elements:

Understanding the relevant regulations

Medical devices are highly regulated to prevent harm to the general public. Although regulations vary from country to country, the primary concerns are invariably patient safety and privacy. When sifting through the regulatory considerations, you will most likely need to consider these key rules and agencies:

Clinical Evaluation Report (CER): This report documents the conclusions of a clinical evaluation of your medical device. It demonstrates that your device achieves its intended purpose without exposing users and patients to further risk.

General Data Protection Regulation (GDPR): A regulation in EU law on data protection and privacy in the European Union (EU) and the European Economic Area (EEA) aimed at giving individuals control over their personal data.

ISO 14155: According to ISO.org, these principles address “good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.”

EU MDR:  In May 2021, The EU MDR replaced the EU’s Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC). Manufacturers selling medical devices within the EU must adhere to these new regulations to ensure their products are safe to use.

FDA: The FDA requires firms that manufacture, repackage, relabel and/or import medical devices sold in the United States to comply with their basic regulatory requirements which ensure the quality and safety of products.

Conducting medical device clinical trials in Europe can be quite challenging—with or without DCT considerations—as the MDR contains approximately 300 line items. Thankfully, many match up with the ISO 14155 regulations or standards, so there’s a harmonization effort. For example, the Annex 15 of the MDR outlines protocol for pre-market clinical investigations is very much aligned with the ISO 14155.

Understanding medical device classifications

All medical devices fall under a category of the medical device classification system. The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act established three regulatory classes for medical devices—although those classes have been broken down further since.

Classification is based on the degree of control required to assure the safety and effectiveness of the various types of devices. Typically, low-risk devices (e.g. eyeglasses) can be self-certified while high-risk devices (e.g. pacemakers) require permanent monitoring.

Class I

Class I medical devices are non-invasive devices or equipment that present minimal potential for harm to the patient or user. According to the FDA, 47% of medical devices fall under this category and 95% of these are exempted from the regulatory process. Examples include bandages, canes, or compression stockings.

  • Class Is
    Class Is is a sub-group of similarly non-invasive devices and includes sterile devices. Examples include examination gloves, oxygen masks, and stethoscopes.
  • Class Im
    Class Im devices are considered low-risk and encompass measuring devices. Examples include thermometers and non-invasive blood pressure machines.


Class II

According to the FDA, 43% of medical devices fall into this category, which includes everything from home pregnancy tests to wheelchairs.

  • Class IIa
    Class IIa devices are low-to-medium risk devices. These may be installed within the body for a short time, between an hour to 30 days. Examples include catheters and hearing aids.
  • Class IIb
    Class IIb devices are typically medium-to-high risk which may be installed within the body for 30 days or longer. Examples include equipment for intensive care monitoring and ventilators.


Class III

Class III devices are high-risk, implanted, or used to sustain or support life. According to the FDA, 10% of medical devices fall under the category of class III devices. Examples include orthopedic implants, pacemakers, deep brain stimulators, and prosthetic heart valves.

Using remote technology in a medical device trial

Almost any medical device study protocol can incorporate elements of DCT.  Although some trials may require a clinician to administer or operate the device, almost all device trials can still leverage remote technology.  Here’s how:

Televisits

Televisits can eliminate the need for on-site clinical assessments in many medical device trials through video interaction with patients and online assessments,

 

eConsent

eConsent allows participants to enroll for trials from the comfort of their homes. A trial’s protocol may include online questionnaires (via web, mobile or native app) to capture everything from eligibility criteria to screening questions to eSignature.

 

In Europe, the hurdle is quite high for a manufacturer to get direct access to a patient to collect medical device data due to the General Data Protection Regulation (GDPR). If a lay user device can be found at the local drugstore, then it may be possible to go directly to the patient as long as the legal requirements for GDPR, Health Insurance Portability and Accountability Act (HIPAA) and Good Clinical Practice (GCP) are being followed.

It also may be possible to obtain explicit consent from patients willing to be contacted by the manufacturer for further research, however, it’s important to fully understand the ethical requirements involved in that possibility. In such a case, the patient must be kept informed of changes and the manufacturer must be as transparent as possible.


Direct-to-patient

Where permissible, medical devices can be shipped directly to patients.

 

medical-device-classes-table

Connected Devices

Connected devices can be shipped to patients, and can then automatically monitor and collect data and transmit it to study sites or, ideally, push it directly to the trial database. These can be used to monitor activity levels, step count, pulse-oximetry, and more.

 

Bluetooth is changing the game for medical devices—and not just for patients. Bluetooth-enabled stethoscopes can now transmit a patient’s heartbeat into paired wireless headphones (or even hearing aids) worn by a physician. Similar remote technologies are gaining popularity as televisits become part of the new normal. Of course, all these new medical devices require extensive testing and require regulatory approval.


Home health nursing

Home health nurses can be enlisted by researchers to travel to collect specimens and provide nursing care in a patient’s home, thus reducing or even eliminating the need for participants to travel. Depending on the type of device or data to be collected, there may be several activities that require the professional oversight and skills of a home health nurse.

 

ePRO and eCOA

Electronic Patient-Reported Outcomes (ePRO) and Electronic Clinical Outcome Assessment (eCOA) offer questionnaires online or via an app instead of on paper. Importantly, with the right platform ePROs can be scheduled or triggered by advanced rules or automation workflows, eliminating the need to contact participants individually.

 

Chat and video calling

Video brings human connection into a clinical trial in many ways. For example, an investigator from a centralized site can talk a participant through the consent process via video call. Follow-ups can be done online through video conferencing. It can also be used to assess if patients are using a device correctly: Is the blood pressure cuff on properly? Are the body sensors in the right spots?

 

DCT offers a myriad of benefits, from lowered admin workloads to higher participant retention. By strategically leveraging a whole host of remote tactics—televisits, eConsent, connected devices, ePRO, direct delivery of medical devices to participants’ homes, video calling—medical device trials can streamline their study protocols. Best of all, these can be applied to a wide range of medical device studies.

No comments yet

Strategies to Minimize Participant and Healthcare Provider Burden in Clinical Trials

January 6th, 2025 by

Patient-reported outcomes (PROs) are a cornerstone of clinical trials, providing invaluable insights into treatment efficacy, patient experiences, and health-related quality of life (HRQoL). Despite their importance, the collection of PROs can place significant burdens on both trial participants and healthcare providers. These burdens often threaten data quality, increase dropout rates, and complicate clinical workflows. Addressing these challenges requires a nuanced approach that balances efficiency, equity, and data integrity.

This article explores practical strategies for reducing these burdens while enhancing the quality of data collection. Drawing on evidence-based practices, ethical considerations, and insights from recent research, it also examines how technology and global perspectives can further streamline the process.

Participant Burden: Challenges and Solutions

The Weight of PRO Collection

Participants face several challenges when completing PROs, including:

  1. Cognitive and Emotional Strain: Complex, lengthy, or redundant questionnaires can exhaust participants. For instance, oncology patients with cognitive impairments often find PROs particularly taxing (Atkinson et al., 2019).
  2. Time and Accessibility Barriers: Rigid schedules and technological hurdles can discourage participation, especially among elderly or underserved populations.
  3. Ethical Concerns: Excessive burden risks violating ethical principles of autonomy and beneficence, reducing trust in clinical research.

Aiyegbusi, Cruz Rivera, and Roydhouse et al. (2024) propose 19 recommendations to address these burdens, emphasizing the importance of clear communication, streamlined surveys, and dynamic feedback loops. Their work underscores that reducing respondent burden requires a comprehensive, participant-centered approach.

 

How to Lighten the Load for Participants

  1. Simplify Questionnaires Without Sacrificing Quality
  1. Flexible Administration Options
  1. Leverage Technology Thoughtfully
  1. Ethical and Cultural Sensitivity
  1. Dynamic PRO Designs and Feedback Loops

Provider Burden: Streamlining Workflows

The Strain on Healthcare Providers

Providers tasked with facilitating PRO collection face distinct challenges:

  1. Administrative Overload: Manual data entry and the integration of PROs into clinical workflows can overwhelm already overburdened providers (Ulrich et al., 2005).
  2. Systemic Challenges: Limited infrastructure, particularly in under-resourced settings, exacerbates these issues.

 

Reducing the Load for Providers

  1. Embed PROs into Existing Systems
  1. Delegate Responsibilities
  1. Training and Education

Enhancing Data Returns: Making Every Response Count

Strategies for Maximizing Data Value

  1. Real-Time Monitoring and Analytics
  1. Longitudinal Analysis for Comprehensive Insights
  1. Combining PRO Data with Clinical Metrics
  1. Transparent Reporting to Stakeholders

Ethical and Practical Considerations

Balancing Efficiency with Equity

While simplifying tools and leveraging technology can improve efficiency, researchers must ensure these strategies do not compromise inclusivity or data validity. For instance, while ePROs are highly effective in high-resource settings, they may alienate participants in low- and middle-income countries (LMICs) without adequate digital infrastructure. Employing hybrid approaches that include paper-based options can mitigate these disparities (Aiyegbusi et al., 2024).

 

Ethical Research Design

Ethical considerations must guide all burden-reduction strategies. Researchers have a responsibility to ensure:

Final Thoughts

Reducing the burdens associated with PRO collection is essential to maintaining high-quality data, improving trial retention, and fostering trust among participants and providers. Researchers can ensure that trials remain efficient and ethical by adopting participant-friendly survey designs, integrating PROs into clinical workflows, and leveraging real-time analytics.

Equally important is the commitment to inclusivity. Bridging the digital divide and addressing systemic inequities will enable clinical trials to reflect the diversity of the populations they aim to serve. Insights from recent research, particularly the 19 recommendations outlined by Aiyegbusi et al. (2024), highlight the importance of innovative, participant-centered strategies to reduce burdens while maintaining data integrity. These strategies will play a pivotal role in advancing patient-centered outcomes and driving innovation in healthcare.

Discover Castor’s eCOA / ePRO Offering

Simplifying the collection of patient-reported outcomes is a critical step toward improving clinical trial efficiency and enhancing participant engagement. Castor’s eCOA / ePRO platform offers an intuitive, flexible solution designed to reduce participant and provider burden. With features like BYOD (Bring Your Own Device) capabilities, adaptive questioning, and centralized data management, Castor ensures that data collection is streamlined without compromising quality.

 

References

  1. Aiyegbusi, O.L., Cruz Rivera, S., Roydhouse, J. et al. Recommendations to address respondent burden associated with patient-reported outcome assessment. Nat Med, 30, 650–659 (2024). DOI
  2. Atkinson TM, Schwartz CE, Goldstein L, et al. Perceptions of Response Burden Associated with Completion of Patient-Reported Outcome Assessments in Oncology. Value Health, 22(2), 225–230. (2019). DOI
  3. Briz-Redón Á. Respondent Burden Effects on Item Non-Response and Careless Response Rates. Mathematics, 9(17), 2035 (2021). DOI
  4. Einarsson H, Cernat A, Shlomo N. Reducing Respondent Burden with Efficient Survey Invitation Design. Survey Research Methods, 15(3), 207–233 (2021). DOI
  5. Hartman V, Zhang X, et al. Developing and Evaluating Large Language Model–Generated Emergency Medicine Handoff Notes. JAMA Network Open (2024). DOI
  6. Loewenstein A, et al. Global Insights on Challenges in Managing Age-Related Macular Degeneration. Ophthalmology and Therapy (2024). DOI
  7. Orozco-Levi M, et al. Pathway to Care and Disease Burden of Pulmonary Arterial Hypertension. BMJ Open (2024). DOI
  8. Ulrich CM, Wallen GR, Feister A, Grady C. Respondent Burden in Clinical Research. IRB: Ethics & Human Research, 27(4), 17–20 (2005). DOI

Comments closed

The New Standard in Participant-Centric Trials: What Castor’s 2025 Updates Reveal About the Future of Clinical Research

May 28th, 2025 by

“We’re merging consumer-grade digital expectations with the complexity of clinical trial compliance.” — Lisa Charlton, Chief Product Officer at Castor

The May 2025 Castor Product Spotlight wasn’t just a feature walkthrough—it was a directional statement. As the boundaries between real-world data (RWD), eCOA / ePRO, direct-to-patient (DTP) delivery, and digital-first engagement continue to blur, Castor has placed a strategic bet on the convergence of flexibility, compliance, and user experience.

In a 30-minute LinkedIn Live session, Lisa Charlton and Conal Nolan pulled back the curtain on the latest evolution of Castor’s platform: frictionless onboarding, end-to-end workflows, modular flexibility, and a renewed focus on reducing both site and participant burden.

Here’s what it all signals—for the future of trials, for technology buyers, and for participants themselves.

Designing With the Participant, Not Just the Protocol

Charlton opened by reframing a persistent challenge: participant-facing technology has historically lagged behind the user experiences people expect from banking, e-commerce, and health apps.

The core thesis?

“If I can bank with an OTP on my phone, I should be able to consent to a trial with the same ease.”

The Castor platform now offers just that—an OTP-first authentication experience that removes login friction without compromising on security. But more critically, it sets the tone for what follows: every subsequent step in the workflow is participant-centered and seamlessly integrated, from recruitment landing pages to eConsent and follow-up eCOA / ePRO tasks.

“You only get one chance to keep a participant engaged. We treat every first touchpoint with that in mind.” — Conal Nolan

From Static Consent to Adaptive Engagement

The traditional approach to informed consent is increasingly incompatible with remote and global studies. Castor’s eConsent experience is built with real-world comprehension in mind: embedded videos, study FAQs, and optional live scheduling links elevate participant understanding while reducing dropout due to confusion or mistrust.

The flexibility doesn’t stop at consent. Sponsors and CROs can control whether consent is self-serve or requires investigator oversight, with real-time notifications and audit trails keeping the process accountable. One-time password verification is integrated at critical steps like form signing—securing both the participant journey and regulatory compliance.

End-to-End DTP: One Platform, Modular by Design

Castor’s 2025 platform advancements reflect a strong commitment to an API-first, modular architecture, allowing study teams to build personalized workflows without starting from scratch.

This was brought to life in the live demo: a participant lands on a branded recruitment page, completes a pre-screener, and seamlessly progresses through eConsent and baseline forms—all on their own device, without app downloads or account creation.

Once enrolled, participants receive personalized SMS alerts prompting follow-up actions or reminders to open Castor Connect, the native mobile app supporting push notifications, offline use, and biometric login.

“Our aim is not to force patients into a rigid protocol workflow, but to adapt the workflow to their lives.” — Lisa Charlton

Real Results from Real Studies

The feature set isn’t theoretical—it’s validated in global real-world studies.

Case Study 1: Fully Remote, Infectious Disease RWE Trial

Case Study 2: Hybrid Model with Remote Capture

These examples demonstrate Castor’s ability to scale across therapeutic areas, geographies, and operational models—delivering both high-touch service and software under one roof.

Compliance, Resilience, and the Road Ahead

Key compliance features—like audit trails distinguishing participant-entered data, offline functionality in Castor Connect, and eConsent audit logs—reinforce the platform’s regulatory readiness. And in scenarios where internet connectivity drops mid-form, auto-saving ensures that no data is lost.

Looking ahead, Castor is developing on-site eCOA / ePRO workflows to further reduce friction in hybrid trials. The forthcoming model will enable data collection at sites with seamless handover to remote follow-up, ensuring no action or data point is missed—even in fluctuating trial environments.

“This is the direction the industry is heading—flexibility without compromise.” — Conal Nolan

Final Thoughts: From Tech-Driven to Participant-Led

Castor’s updates reflect a broader shift in clinical research: technology can no longer be an operational afterthought. It must serve the dual goals of scientific rigor and participant empathy.

The 2025 Product Spotlight makes it clear: Castor is building for a world where participants expect digital fluency, and study teams need tools that meet those expectations—while accelerating timelines, increasing retention, and improving data quality.

For RWE leaders, digital trial managers, and platform evaluators, this isn’t just a better experience. It’s a strategic imperative.

Explore how Castor’s participant-first technology can help you deliver more compliant, engaging, and efficient studies. Let’s build the next generation of trials—together.

Comments closed

Do Patients Really Understand Clinical Trials?

May 2nd, 2025 by

Why comprehension is the Achilles heel of informed consent—and what to do about it.

When a patient agrees to join a clinical trial, they’re not just giving a signature—they’re placing real trust in researchers, physicians, and the system as a whole. But here’s the uncomfortable truth: a large portion of participants don’t actually understand what they’ve signed up for. And that gap? It’s not just an ethical issue. It’s a barrier to trial success.

Let’s break this down.

1. Informed Consent ≠ A Signature

Informed consent should be about clarity and autonomy—not legalese.

The foundations are clear: Belmont Report, Declaration of Helsinki, decades of ethics frameworks (U.S. Department of Health and Human Services, 1979; World Medical Association, 2013). But in practice, we fail to deliver on the core promise—patient comprehension.

Pietrzykowski & Smilowska (2021) showed that half of participants don’t understand core concepts like randomization, placebo, and risks. That’s not a small problem. That’s structural.

2. Poor Understanding = Poor Outcomes

If participants don’t understand the trial, they leave.

That’s not conjecture. According to Fogel (2018), those with lower comprehension are twice as likely to withdraw early. The implications:

And ultimately, delayed or failed trials.

3. Traditional Consent Methods Don’t Cut It

Consent forms today are dense, jargon-filled, and often completely inaccessible.

Even without barriers like low literacy or language differences, complex trial designs are hard to grasp. Tam et al. (2015) and Glaser et al. (2020) both highlight the same issue: critical concepts are routinely misunderstood by participants across all populations.

So, why are we still defaulting to static PDFs and rushed consent conversations?

4. What Actually Works

We don’t need more documentation. We need better communication.

The good news: there are proven ways to bridge the gap.

This isn’t about ticking boxes. It’s about building real understanding.

5. Where Castor Comes In

This is exactly the kind of problem tech should be solving.

At Castor, our eCOA/ePRO platform is designed to make complex trial information simple, personalized, and always accessible. We enable:

It’s not just more readable. It’s more trustworthy.

6. The Bigger Picture

Improving informed consent is not just a compliance play—it’s a quality imperative.

When patients understand the trial, they’re more likely to stay in it. That means better adherence, higher-quality data, and faster, more reliable insights. It also means trust. And right now, the clinical trial ecosystem needs more of that.

Nusbaum et al. (2017) said it well: effective risk/benefit communication builds confidence in research itself. We need that—not just for trial success, but for the broader perception of science in society.

Final Thought:

If we want to run better trials, we need to start by asking: “Do participants really understand what’s going on?”

Right now, the answer is often no. But it doesn’t have to be.

Let’s stop viewing informed consent as a checkbox. Let’s build systems that make comprehension the starting point—not the afterthought. That’s how we improve outcomes—for patients, for researchers, and for the entire healthcare system.

Comments closed

Try Castor EDC For Yourself

Start designing your own study structure and forms today.

Try For Free
Back to top