When designing studies, clinical researchers have never had more options at their fingertips. As technology leaps forward, companies are sending more notifications, collecting more data, and adding more apps, wearables, and ePROs to research. But researchers need to take into account the fact that many potential players face burnout and uncertainty after more than two years of the pandemic.
During the epidemic, approximately four out of ten More adults in the U.S. report symptoms of anxiety or depression than one tenth Adults who reported these symptoms between January 2019 and June 2019. For patients with new health problems or battling existing conditions, the pandemic has led to delayed diagnoses, delayed surgeries and more uncertainty.
All in all, many potential participants were tired and stressed. Some may even be wary of adding another commitment by joining a clinical trial. Therefore, research needs to prioritize simplicity, authenticity, and utility to earn patient trust for better enrollment and retention.
People-Centered Admissions Admissions
Informed consent should not be read like a Ph.D. paper. It should be simple, likely in the form of electronic consent using a mobile phone, tablet or computer. This remote approach lowers barriers to registration by reducing travel costs, eliminating possible Covid-19 risks, and allowing participants more flexibility in their schedules. It increases comprehension and retention of information as complex procedures or research processing can be visualized and explained out loud. It allows study participants to choose their preferred learning method and can include features to help disadvantaged groups (eg, visually impaired, pediatrics).
eConsent also simplifies recruitment by reaching and interacting with patients on the platform they use. Social media platforms like TikTok, Snapchat, and Instagram have user-friendly advertising interfaces that put recruiting materials in front of a larger percentage of qualified participants. Clinical researchers can streamline their search efforts to expedite identification of suitable participants.
Decentralized recruitment approaches can reach underserved minority groups that are underrepresented in clinical research. This supports the hiring of remote researchers representing patient populations or with culturally competent expertise to communicate scientific concepts to populations who have experienced autonomy deprivation. Using video chat, staff can guide participants through the informed consent process. eConsent provides more opportunities to participate in the consent process and can provide participants with empowerment, ownership, and autonomy—often an important step in overcoming hesitancy to join a study.
Improve technology integration of patient data
Another key to simplifying, patient-centered trials is automation. In particular, APIs can overcome the need for patients to use multiple applications simultaneously. Researchers should explore intuitive software that provides a great user experience and useful features. This has been a challenge before, as regulatory and developmental contexts have created a very commoditized environment with more similarities than differences in research tools. But now, innovative companies are offering new solutions—researchers should choose the best research platform that provides the best patient experience, while supporting high-quality clinical research.
Another way to use technology to improve the participant experience is with direct-to-patient devices. It’s an idea to send participants a medical device with a Bluetooth connection pre-installed with the appropriate telemedicine products for easy access. This approach also helps reduce workload at research sites, as sending participants preconfigured devices (rather than a BYOD model) reduces service desk staffing needs. Ideally, participants should use the accompanying device or phone to complete various tasks in the study, such as reporting results and communicating with researchers.
Harness the power of RWD
In the near future, real-world data will play an even bigger role in clinical trials — for the benefit of all involved. If researchers can show that measurements, such as heart rate, can infer the same results as more complex measurements, such as electrocardiograms, this could pave the way for further simplification of study designs. For example, if a study involves a chronic condition that participants must visit a doctor to manage, such as blood pressure, then real data from the doctor’s office could be used in the study, rather than taking the same measurement twice. In other cases, participants can use wearable devices to collect data in real time and transmit it to the study site. This efficiency can increase study registration and retention rates and allow for the continued acquisition of more data.
Let’s promote simple, authentic and practical learning – give participants a break! Let’s meet people where they are and put their needs first. By doing this, we will recruit more participants and hopefully keep them engaged and retain them throughout the study. Let’s work together to develop new treatments for a better tomorrow.
Photo: Undefined Undefined, Getty Images
