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
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.
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.
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. Arguably the greater risk is to create a vacuum in which patients cannot communicate as patients will almost definitely find a way to communicate. Those unexpected interactions would not be monitored to ensure the blinds are maintained.
Studies should look at key relationships in the participants’ lives to understand is their support system. In many cases, this will be a spouse or partner, sibling, son or daughter, etc. The support that participants gain from these relationships is critical to their experience in the study. So studies should engage with these key people who may be transporting the participant to the study, caring for them when they experience side effects, and reminding them about appointments. Researchers should see these key individuals as partners in the participant’s care.
Outside of the patient’s organic relationships patients may find it helpful speaking with a therapist about their experience. This can be especially important in studies for patients with serious or life changing conditions.
Another route for patient support is having community nurses who meet with patient groups on a weekly basis. This helps patients feel like they are part of a bigger picture and that they have people to talk to who understand what they are going through. Studies frequently change, and nurses can keep patients informed of changes and the reasons behind the changes.
New technologies such as augmented or virtual reality can illustrate the possible risks better than a form or explanation. For example, telling a patient that they may experience “tardive dyskinesia” in the course of the study is not nearly as helpful as showing them what that experience is like. Consider incorporating these technologies into your trial to keep patients engaged and fully informed. Virtual reality can also be used to “put the patient in the room” with a patient who has been through the study.
Like most efforts to improving health care outcomes, improving clinical trial retention is a matter of zeroing in on patient’s expectations and priorities. These ideas are a a push in the direction of patient centered clinical trials.
I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the first podcast on Soundcloud.