Minimizing Participant Loss in Clinical Trials – Part 1

Once patients are enrolled in your clinical trial, how do you get them to stay? We will examine the factors that determine if patients will remain enrolled in your clinical trial. Education during non-study visits Creating a network of support for patients can extend beyond the study-related visits. In fact, the routine primary care visit is a good opportunity to expose patients to the possibility of a clinical trial in a no-pressure environment. It can be a space to provide some background information and let the patient decide to follow up (or not) regarding participation. Remind participants of the big picture In most cases, people do not decide to participate in a clinical trial for the money, but rather for the opportunity to help health research. Study participants might have been excited about contributing to health research when they enrolled, but after all the visits and time invested in the study, they lose sight of their impact. Remind patients why their choice to participate in the study is impactful. Spread positive awareness of clinical trials in your office, share good news about patients benefiting from health research. Participants will appreciate knowing the positive impact that their actions are having on patients. Convenience to the patient Some clinical trials require extensive in-person visits and travel, which can make patients question their commitment to participating in the study. If there are aspects of the study that could be done from the patient’s home, consider arranging for that. A nurse could visit the patient at home to draw blood take a measurement. Additionally, appointment reminders and flexible hours to work with differing schedules will help participants make and keep appointments. Fear of the unknown Patients are told what will happen in the course of the study, but it is not reasonable to expect them to remember every detail discussed during the informed consent process. Instead, it would be great to give patients a handout or takeaway folder that contains all the information presented in a format that those outside the medical professions can understand. Researchers should always make the informed consent form accessible to patients, so they can refer back to it throughout the course of the study. Engage with patient communities Patient Leaders Some people with illnesses find other people with similar conditions to lean on for support and guidance. If you are enrolling a patient population in a clinical trial, you may consider reaching out to a patient group to interview the leaders. It may also help to organize a focus group with the group leaders to find out more about patient priorities and expectations. It may surprise some health care professionals that there are patient leaders since these leaders are not usually considered among the key opinion leaders in medicine. The patient leaders are trusted by patients and have intimate knowledge of the patient experience. Contemporary Participants Past and current participants can play a significant role in easing the concerns of recruited participants by talking them through what their individual experiences. Side effects that sound scary on paper might not be that important to patients, whereas a test that seems routine to the medical professional was frightening for patients. Unblinding Concerns It is also important to proactively address concerns around unblinding. The concern that patient groups could unblind patients from their course of treatment is valid, but there are ways to ensure the blind is maintained.