Keeping Subjects in Clinical Trials

June 04 , 2020

When conducting clinical trials, patient recruitment is key, but patient retention may be even more important for the overall results of the trial. Maintaining participants in a study ensures that the study stays on track, saving the study site time, money, and resources. Study participation is voluntary. Let’s look at the different reasons why a subject might choose to withdraw from a study and methods to keep them on board.

According to research, seven out of 100 patients who are identified as viable for a study will fully complete it. This number is determined by the “Leaky Pipe” Analysis. From the 100 patients who enter the funnel, 31 will pass through the pre-screen and less than half will consent to the study. Then, approximately nine patients will be randomized and two will drop out, leaving seven patients to finish. The goal is to reduce the leakage shown in this analysis, thereby maximizing the number of patients who choose to remain in the study.

Many factors can cause subjects to withdraw from a clinical study. These include the inconvenience of the study site location, scheduling conflicts, and forgetting visits. Study subjects may also experience fear or anxiety, have physical instability, or feel as if their condition is not improving. It is possible that participants simply do not want to comply with the protocol, due to a lack of appreciation and misunderstood expectations. Of course, any reason a patient gives for dropping a study is valid, however, it is imperative that clinical research teams understand the motivations for doing so to prevent it from happening as frequently.

To retain the highest number of participants, study sites must emphasize good communication and comfort. For example, sending visit reminders and quick responses to study inquiries will encourage patients to continue with a trial. The research team must also stress the importance of participation and show recognition and appreciation when a patient complies. Finally, a site should provide a patient-friendly environment to make it feel a bit more comfortable than a standard medical office. Comfort also means accommodating the schedules of participants when possible.

Why patients withdraw from clinical trials might be study dependent, but investigators should do their best to understand the psychology behind patient behavior to improve the patient experience. There is certainly a need for more effective methods to hold participants, but for now, following basic guidelines and observing participant motivations is the way to go. Ultimately, clinical trials seek to proceed smoothly and in a timely manner, thus research teams are always working to find ways to reduce study delays of any kind and to obtain a complete data set.