This is the third of three case studies covered in a webinar Castor held with AKRN Scientific Consulting. Watch the webinar for more insights from the AKRN team. You can also download this case study below.
Over-the-counter (OTC) drugs play an important role in accessible and affordable healthcare. According to a recent survey, 90% of European consumers believe self-care is a necessary part of managing minor ailments, chronic conditions, and diseases. This is an issue that not only affects European countries but also has the potential to create large-scale global cost savings. A study of seven European countries found that an increase in self-medication could save more than €11.5 billion for health systems annually.1 Consumers are eager to have the tools and treatments to take care of themselves, but they need OTCs to be accessible and available first.
Company Z’s device is designed to help patients with earwax blocks both prior to and after surgical removal. The substance loosens wax and makes it simpler to remove after it’s sprayed into a person’s ear, while also reducing irritation. Realizing the potential of their product as a highly-effective OTC product, Company Z teamed up with their experienced medical device CRO partners, AKRN Scientific Consulting, to do a clinical study to demonstrate the effectiveness of their solution.
The project was originally straightforward, with approximately 100 participants at a handful of locations across Europe. However, obtaining a thorough grasp of how their product affected real-world consumers and gaining regulatory clearance was an ambitious aim. AKRN had to deploy three unique patient surveys to give investigators a complete view of the product’s simplicity of use as well as what symptoms people reported before and after using the spray. Patient demographics made conducting this study even more challenging. The ear wax removal spray would be used primarily by elderly individuals. AKRN needed to find a technology solution that was easy for elderly patients to understand and navigate.
Designing a seamless workflow for electronic patient-reported outcomes (ePROs)
Experts at AKRN found the affordability, accessibility for all participants, and seamless electronic data capture (EDC) integration they needed with Castor.
Native integrations enabled data to flow seamlessly between the patient-facing mobile application, where patients enter their data, and the clinical data management system, where researchers can analyze patient data. With ePRO available natively within Castor, survey data entered by patients would populate directly within their EDC system for researchers to review, saving time testing external integrations and the budget needed to purchase them.
For this study to be successful, ePRO surveys had to be accessible to the elderly patient population enrolled. Castor’s surveys were able to be designed and distributed in a way that felt familiar and comfortable for participants. Each participant received a simple email with a link to complete the survey, on their own devices and on their own time. If a participant wasn’t comfortable filling out the form on their own, they had the option to complete the survey with a provider during an in-person visit. With Castor, providers could easily print the surveys, hand them to participants to fill out, and enter results into Castor EDC.
Collecting feedback from participants in a real-world setting
Capturing accurate feedback from patients in a real-world setting was essential for the study’s success, and Castor’s ePRO proved to be the ideal platform for engaging with patients as they lived their everyday lives.
Feedback from patient outcome assessments gave AKRN and Company Z an acute look into how patients felt about their product, how easy it was easy to use for the average layperson, and whether they noticed symptom relief. This feedback was essential to ensure that the product met the needs of consumers looking for an OTC solution that was easy to incorporate into their routine, while effectively relieving ear wax blockage and irritation.
“It was a bonus feature to give patients the opportunities to actually report outcomes to know their story in a different way, a different place, from the patient themselves.”
– Iñigo Marquet De Solís, Clinical Research Scientist & Data Manager, AKRN By Namsa
Enabling patients with a solution to manage their health
An ePRO solution that was easy for participants to use enabled AKRN and Company Z to engage with a participant population that, on their own, might struggle with a technology solution that they’ve never used before. Castor’s familiar, easy-to-use ePRO surveys made real-world data collection possible, all while helping AKRN and Company Z conserve their budget and IT resources with native EDC integration. With an effective ear wax removal solution on the market that anyone can purchase over-the- counter, AKRN and Company Z are giving ear surgery patients a qualified means to manage their health.
- “The Value of OTC Medicines – Pfizer.” https://cdn.pfizer. com/pfizercom/health/VOM_OTC.pdf. Accessed 2 Sep. 2022.