Never before have clinical researchers had more options at their fingertips when designing a study. As technology leaps ahead, companies are sending more notifications, collecting larger amounts of data, and adding more apps, wearables, and ePROs to studies. But researchers need to be considerate about the fact that many potential participants are dealing with burnout, and uncertainty after more than two years of pandemic life.
During the pandemic, about four in ten adults in the U.S. have reported symptoms of anxiety or depressive disorder, which is a significant rise from the one in ten adults who reported these symptoms from January to June 2019. And for patients suffering from new health issues or struggling with existing conditions, the pandemic has caused delayed diagnoses, postponed surgeries, and more uncertainty.
All said, many potential participants are tired and stressed. Some may even be wary of adding another commitment by joining a clinical trial. Therefore, research studies need to prioritize simplicity, authenticity, and practicality to earn patient trust for better enrollment and retention.
Human-centric recruitment and enrollment
Informed consent shouldn’t read like a Ph.D. thesis. It should be simple, most likely in the form of eConsent using a phone, tablet, or computer. This remote approach lowers enrollment barriers by reducing travel costs, eliminating possible exposure to Covid-19 risks, and allowing greater participant flexibility with their schedule. It increases comprehension and retention of information since complex procedures or study treatments can be shown visually and explained out loud. It allows study participants to choose their preferred method of learning and functionalities can be included to help vulnerable populations (e.g., visually impaired, pediatrics).
eConsent also simplifies recruitment efforts by reaching and engaging with patients on the platforms they use. Social media platforms such as TikTok, Snapchat, and Instagram have user-friendly advertising interfaces that position recruitment materials in front of a greater proportion of eligible participants. Clinical researchers can streamline their search efforts to accelerate efforts to identify the right participants.
A decentralized approach to recruitment can reach underserved minority populations who are underrepresented in clinical research. This supports hiring remote study staff who are representative of the patient population or who have cultural competency expertise in communicating scientific concepts to populations who have experienced deprivation of autonomy. Using video chat, staff members can guide participants through the informed consent process. eConsent offers more engagement with the consenting process and can offer participants empowerment, ownership, and autonomy—often a significant step in overcoming hesitation in joining a study.
Technology consolidation for improved patient data
Another key to streamlined, patient-centric trials is automation. In particular, APIs can overcome the need for patients to juggle multiple apps. Researchers should explore intuitive software that offers excellent UX and helpful features. This has previously been a challenge since the regulatory and development background created a very commoditized environment with research tools that were all more alike than different. But now, innovative companies are offering new solutions—and researchers should select the optimal research platform that offers the best patient experience while supporting quality clinical research.
Another way to leverage technology to improve participant experience is direct-to-patient devices. Sending participants a Bluetooth-connected medical device shipped with a phone preloaded with an appropriate telehealth product for easy visits is one idea. This approach also helps alleviate work for the study site, as sending participants pre-configured devices (rather than BYOD models) decreases help desk staffing needs. Ideally, participants should use the shipped device or phone for various tasks within the study, such as reporting outcomes and communicating with researchers.
Harnessing the power of RWD
Real-world data will play an even larger role in clinical trials in the near future— to the benefit of all participants. If a researcher can show that a measurement (e.g. heart rate) can infer the same thing as a more complicated measurement (e.g. electrocardiogram) this paves the way for further study design simplification. For example, if a study involves a chronic condition the participant must visit a physician to manage, such as blood pressure, then the real-world data from the physician’s office could be used for the study rather than taking the same measurement twice. In other cases, participants can use a wearable to collect and transmit data to the study site in real-time. This kind of efficiency can boost both enrollment and retention rates in studies and allows for more data to be acquired consistently.
Let’s push for simple, authentic, and practical studies – and give participants a break! Let’s meet people where they are and put their needs first. By doing so, we’ll recruit more participants and hopefully keep them engaged and hold on to them throughout the entire study. Let’s work together to develop new cures for a better tomorrow.
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