The health care technology market is growing, and fast. Experts calculate a compounded yearly growth of almost 20% and predict the value of the connected medical devices industry may increase from $30 billion (in 2021) to $100 billion by 2030 (1).
Let that last figure sink in. In less than ten years, the industry for devices that collect, track, manage and analyze data may more than triple in value.
Unfortunately, the technology researchers use to manage data collection for clinical trials has not kept pace with the industry’s rapid growth. Innovative software solutions and interoperability breakthroughs are out there, but the clinical research world has been slow to adapt (2).
Out with the old, in with the new
It is time to break away from traditional data management tools & guidelines to embrace new tech. The clinical trial industry is facing a dramatic shift from siloed, cumbersome processes to a fully connected, interoperable clinical trial platform for collecting and analyzing data.
Let’s explore where we are now and how we can bridge the gap between old, inefficient processes and a new, comprehensive way of approaching modern clinical trials (Figure 1).
What are eCRFs within the old paradigm?
The old paradigm for clinical data management has iterative steps.
For example, researchers may have to upload paper sources and enter the same data into electronic forms. Source data verification and manual edit checks ensure data is correct but take time and personnel. Double data entry and cumbersome validation procedures burden clinical trial administrative staff and physicians.
Today, clinical trials use isolated technology tools like Electronic Case Report Forms (eCRFs) to collect, manage, and analyze data. These eCRF forms are built into electronic data capture (EDC) systems that let researchers and clinical staff enter data directly into the system. Researchers can tailor eCRFs to fit each study, saving time and money.
When we consider the advantages of eCRFs, it seems crazy to think of them as outdated and put them in the same category as paper CRFs. However, that is the danger of holding on to the old ways in the ever-evolving world of clinical research tech. eCRFs are not going away, but they represent a siloed system where data is entered and processed separately. They are a holdover on the way to a seamless, single platform.
Introducing a cohesive data management solution
The clinical trial tech community is moving toward a new way of running clinical trials: pairing a clinical data management system (CDMS) with a fully decentralized clinical trial (DCT) platform. This innovative paradigm puts all data management components into a single system where automation and interoperability reign.
The CDMS/DCT combination incorporates all clinical trial data components, from electronic consent (eConsent) forms to scheduling, televisits, and data from medical devices and patient apps. CDMS/DCT has the potential to import real-world data (RWD), label electronic source (eSource) data and conduct automated edit checks to ensure the quality of the data. A single system collects, stores, and processes all clinical trial data.
Unfortunately, we’re not there yet. Clinical trial technology hasn’t progressed to the point where this combo is possible, and the research world hasn’t fully embraced new tools.
Bridging the gap
Clinical trial tech companies are moving toward the CDMS/DCT model by making the most of current tech and looking to the future. Here are four ways the community is linking old and new:
Link #1: Automated data capture
One step to a comprehensive data management solution is adopting application programming interfaces (APIs) to interact with EDCs. APIs help software systems (like electronic health record (EHR) databases at hospitals) communicate directly with EDCs. APIs may eliminate double data entry, paper uploads, and even source data verification.
APIs can also connect sensors, wearables, and medical devices to an EDC system, helping researchers collect biometric data and other digital endpoints from patients in real-time, and in a real-life setting. Wearable integration provides a better window into a patient’s health – instead of pulling a patient into an unfamiliar clinical setting to collect data, an automated data capture solution can communicate directly with technology that patients are already using in their daily lives, enabling researchers to collect more accurate data more often.
Link #2: Electronic surveys
Electronic clinical outcome assessments (eCOAs), like electronic patient-reported outcomes (ePROs), offer a streamlined solution for cumbersome and time-consuming paper uploads. Clinicians design surveys to send to patients who complete them on familiar devices. Survey results move automatically into EDCs, where clinicians can analyze them.
Link #3: Transparency
Reworking simple items such as the labeling system for software versions can ensure everyone uses the most current product. In this example, a clinical trial software company included year and month in addition to patch numbers on their labels to make it easy for customers to identify the age of their version. Transparency in details, like software versioning, is a forward-thinking step towards a more efficient way of doing things.
Link #4: Real-time reporting
Real-time reporting gives added visibility to how trials are performing as they are happening, allowing researchers to identify gaps and issues with endpoints and adapt accordingly. Currently, select clinical trial tech companies use simple real-time reporting. In the future, real-time reporting will be readily available in every aspect of a clinical trial.
How you can start creating a more cohesive clinical trial ecosystem
API and ePRO integrations, automated data capture, and software versioning help bridge the gap between old, inefficient ways of conducting clinical research and a more connected, interoperable way of collecting and analyzing clinical trial data.
Even though incorporating these virtual elements and taking the leap into digitization can feel intimidating, Castor’s solution is easy-to-use, and can act as the first building block to a more cohesive clinical trial platform for executing your studies. All you need to start a decentralized trial is technology to support consenting participants and reporting their trial data.
We can also provide eCRF design & training within this new framework, on a limited basis, from our team of experts.
Get started by scheduling a demo of Castor today, seeing how a modular EDC solution can act as your launchpad for digitization success.
Resources
- Datavagyanik Research and Analytics Firm. Electronic clinical outcome assessment (eCOA) solutions market—A disruptive technology. Digital Journal. https://www.digitaljournal.com/pr/electronic-clinical-outcome-assessment-ecoa-solutions-market-a-disruptive-technology. Published February 16, 2022. Accessed April 28, 2022.
- Kellar E, Bronstein S, Caban A, et al. Optimizing the use of electronic data sources in clinical trials: The technology landscape. Ther Innov Regul Sci. 2017;51(5):551-567.