Patient recruitment and retention tactics vary as much as the protocols they support. While the primary focus is on the recruitment of individuals into clinical trials, sometimes it’s difficult to keep people in a clinical research study after they have signed up. Understanding why people drop out, when they typically drop out and uncovering the root cause is the basis for many retention strategies.
One of the main reasons people discontinue participating in clinical trials is simply “because they can.” According to the language in the informed consent form (ICF)—the comprehensive legal and regulatory document that spells out the contractual rights of the study participant—patients can stop participation at any time for any reason. The execution of the ICF is required documentation to initiate screening or participation in any clinical trial. Because of the clarity of the message, many patients actually do.
How many study participants act on that fundamental right varies from study to study, but according to The Prevention and Treatment of Missing Data in Clinical Trials, patient dropout rates in phase III clinical trials “can often be very substantial,” sometimes more than 30%. This percentage can be more in some studies, especially studies with long durations, multiple blood draws, fasting requirements and invasive procedures. Other reasons people drop are not necessarily study specific. A participant’s motivation may diminish because of inconvenience factors like parking, appointment times and waiting room time. Complex studies with multiple endpoints and inconvenience factors create additional burdens that negatively affect both the study site and study participants.
Basic retention strategies that historically have been implemented include study-branded appreciation items. Examples range from tote bags and branded water bottles to more sophisticated objects or devices. Unfortunately, many of these items intended to show appreciation to the volunteering patient miss the mark. Objects themselves don’t show value to a participant—it is how they are treated that matters. Imagine extended time in a waiting room, not having a parking spot, encountering busy staff who have little time to engage and then being given an object of minimal value. In this example, the objects may do little to enhance the appreciation felt by the study participant.
The study site staff’s treatment of the patients themselves may be the most important factor in retaining patients. Sites can create value among participants by proactively cultivating relationships and remaining in close contact with patients through regular, medically-oriented calls to patients and mailing study appointment reminder/thank you cards. Provide sites with a set of subject-focused materials that will recognize the subjects’ efforts and commitment toward the study and make them feel part of a special community helping to advance research for themselves and others like them. Retention items should be carefully selected and focused on building loyalty to the study and will reinforce messages such as the importance of compliance, the value of the subject’s participation to science and the support available at the clinical site.
CISCRIP’s Medical Heroes is a retention program that puts volunteering for a clinical trial into perspective. This entire concept is based on the premise that those participating in clinical trials are heros and deserve to be recognized for their contribution to medical research. The Medical Heroes Campaign shines a light on the importance of the “gift of participation.” Retention programs should remember that most people participate in clinical trials for altruistic reasons. The top two reasons people volunteer for clinical trials, according to CISCRIP, are to advance medicine and to improve the lives of others. Keeping the patients motivation in mind is the first step in developing a retention program that truly values the patient commitment.
Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Currently, she provides recruitment expertise, strategy and leadership as Principal Consultant of Accelerate Clinical Enrollment. Email comments and suggestions to email@example.com.
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