It’s widely understood that patient recruitment is one of the most critical and yet most challenging aspects to a successful clinical trial. In fact, many trials fail to reach recruitment goals, with far-ranging implications for investigators, sponsors, study participants, and the population affected by the disease or condition under study.
Fortunately, there is a significant positive impact that effective patient engagement can have on recruitment and retention. This post explores how to engage patients and ensure recruitment efforts that consistently meet or exceed expectations.
Overcoming recruitment challenges
It is well known that recruitment is a challenge for clinical trials. Currently, an astonishing 85% of all clinical trials fail to recruit enough patients, 80% are delayed due to recruitment problems, and dropout rates remain high.
One key hurdle to recruitment challenges is the burden placed on participants in traditional clinical trials, where participants are required to travel onsite for screenings, evaluations, and more. This can be incredibly inconvenient, as potential participants may not be able to secure transportation or get time off from work, or may be too ill to travel. In addition, many ideal potential participants may simply live too far from research sites to even consider being part of the trial, thereby drastically limiting the recruitment pool.
To solve for the challenges above, many sponsors have begun to shift toward the use of Decentralized Clinical Trials (DCTs), a patient-centric approach which dramatically expands access by allowing participants to be screened and to join trials from almost anywhere. This provides a critical opportunity to create a more patient-centric study.
Design the study around participants
The importance of involving patients and/or caregivers with relevant experience living with the disease or condition, and doing so early in the research design and development process, has become increasingly understood. Regulators such as the Food & Drug Administration (FDA) and the Medicines & Healthcare products Regulatory Agency (MHRA) have recommended such early involvement as a way to improve the quality and relevance of research to participants. Naturally, participants who feel their voice is heard in the trial design process will be more inclined to join and remain engaged with the trial.
How to bring patients into your clinical trial design process:
- Work closely with patient advocacy groups to find ways to incorporate the patient voice early in the protocol design process
- Utilize digital technologies like DCTs, eConsent, and TeleMedicine to allow flexibility of data capture and relieve the burden on patients and/or their caregivers to travel and/or attend lengthy study visits
- Focus on the manifestations of the disease or condition and the impact to the patient and/or caregiver to ensure the selected trial endpoints reflect aspects of health that are meaningful to the patient with respect to how they feel, function, and survive
- Provide participants with clear information they can easily digest and understand, and offer it using digital solutions (e.g.: videos) that allow presentation of complex content in a more engaging and comprehensible way. Participants who firmly grasp what’s expected of them throughout the trial will likely be more inclined to participate, and less inclined to withdraw as a screen failure or even later on.
Through Medable's Patient Caregiver Network, we bring the patient voice into the development of the clinical trial experience; Medable’s platform is designed around an inclusive trial experience that is both human and data-centered.