Clinical studies are the key to finding safe and effective new ways to prevent, detect, treat, or manage medical conditions. Despite the indisputable value of clinical studies, the participant experience remains flawed. Often in studies, participants do not feel supported or cared for by study teams. Instead, they may feel purposeless or confused from an absence of guidance. The lack of attention towards the participant experience reveals a systematic problem in failing to recognize the most valuable resource of clinical studies: the participant.
Defining The Participant Experience
The participant experience consists of any interaction the participant has between the first time they hear about the study to completion. From screening to follow-up– every message, phone call, email, and in-person conversation the participant has is part of this experience.
You may already be familiar with the challenge of participant retention in clinical studies. Eighty-five percent of clinical studies fail to retain enough participants, and the average dropout rate is about thirty percent across all clinical studies.
If we look beyond these statistics, we can dive deeper into why participants are dropping out of studies. Our team spoke to over 100 study coordinators in different therapeutic areas to gain more in-depth insights into the root of the problem.
Sarah, a cystic fibrosis participant, saw a Facebook advertisement for a new CF clinical study. She clicked on the ad and filled out a form with her contact information, hoping she would be eligible to participate in the study and potentially test a new treatment to ease her symptoms. A week after clicking on the ad, Sarah finally heard back from the research staff with an invitation to attend a screening visit.
According to a study by CenterWatch, 69% of study volunteers do not get to this stage of the study, meaning most volunteers do not make it to the on-boarding stage at all. Sarah is excited to be one of the few who is on-boarded.
Once she joins the study, she receives a half sheet of paper containing her upcoming appointment information. This small piece of paper is easy to accidentally lose or throw away– both of which happen frequently, according to the study coordinators we spoke with.
Sarah does not receive a reminder for her appointment. If she forgets the date/time of her next session, she must call the study coordinator directly, which inconveniences both Sarah and the coordinator. Without appointment reminders, coordinators must rely on participants remembering to show up to their appointment at the designated time, which often doesn’t happen due to the busyness of participants’ lives.
Sarah begins her clinical study visits at a local hospital, where she spends a few hours each week. She and the other participants in her CF study are offering their time and energy to the research, although they do not receive any positive reinforcement to remind them that their contributions are instrumental to science and society. This makes participants like Sarah feel as though they are not valuable to the study, which may discourage them from later participation in research.
After the study is complete, Sarah is not sent the published study results. Not seeing a tangible product of her contributions makes her feel as though she did not have a stake in the research. It might also turn her away from future involvement in clinical research, despite being a valuable contributor.
To make contact between participants and researchers easier and more time-efficient, many parts of the process can be automated.
Researchers should also work toward designing protocols with participant input in mind. Participant advocacy groups (PAGs) can provide valuable input to help researchers develop increasingly participant-centered studies. PAGs work toward creating better outcomes for participants by recruiting participants for studies, helping participants make decisions about their care, and providing participant and caregiver data to healthcare networks, among other efforts. The clinical study process will benefit from taking the time to gain a better understanding of their participants’ problems before trying to offer solutions.
Root Health’s Intelligent Participant Assistant helps automate participant contact and encourages researchers to understand their participants at a deeper level. Root makes it easy to do quick surveys and focus groups with PAGs to get insights on study design. The platform takes participants’ perspectives and emotions into account to improve the quality and efficiency of clinical studies, both for researchers and participants like Sarah. We’ve accomplished this by searching for the core problem and solving it in a manner that empowers both participants and researchers.
If Root had managed Sarah’s study, we would have done our best to provide a supportive and enriching study experience. With Root, Sarah can independently self-screen and complete her onboarding process right from home. Appointments can be set up whenever Sarah has time because Root is available 24/7. Sarah will also receive text messages to remind her of her appointments from Root to make sure she doesn’t miss anything, no more tiny sheets of paper. If Sarah has any questions or needs any help, Root is there.
By changing our perspective to focus on the participant experience in clinical studies, we can work toward reducing dropout rates and improving the overall clinical study experience. Let’s make studies easy and rewarding for participants like Sarah to contribute to the future of clinical research.
Root Health is a communication platform with an AI Virtual Assistant called “Root” that uses automation to streamline and accelerate clinical research. You can watch a short video to learn more at https://roothealth.co/