Patient engagement is critical to the success of oncology clinical trials, many of which have endpoints that require study participants to be followed for many years to evaluate side effects and long-term survival data. And yet, sponsors often postpone careful consideration of strategies for patient engagement and retention until after the treatment phase of their studies. Consequently, patients may be lost to follow-up, or protocol amendments may be required to increase retention, adding cost, delaying timelines, or even adversely impacting data quality. Another risk frequently overlooked is the potential for patients to perceive study participation as a negative experience, which can make recruitment for future clinical trials even more challenging.

Integrating patient perspectives

Patient engagement is valuable not only for gathering protocol-specific insights, but also for informing the overall recruitment and retention strategy. Combining data with a deep understanding of the patient perspective is crucial in oncology studies, since each patient has a unique experience with their disease and their own approach to coping with their condition, both physically and psychologically. Understanding these nuances makes it easier for sponsors to design clinical trials that will be accepted by potential patients as a viable treatment option.

Sponsors should consider engaging with not just patients, but also family members, caregivers, patient advocates, and advocacy groups. Useful insight to gather include disease impact, current treatment, unmet needs, barriers to adherence, and points in the care journey where patients are most likely to consider investigative treatments.