FDA Suggested Ways For Including Patient Perspectives in Clinical Trials
(Thursday, January 27, 2022)
The experiences and perspectives of patients and their caregivers could be invaluable in the design of clinical trials intended to evaluate a new product for them. However, the FDA expectations from the process used to involve patients in clinical trial design may create challenges for the sponsors and patients alike. In a new guidance document released this week, FDA emphasized its support for collecting patient perspectives on all aspects of clinical trial design but proposed limits which could practically hamper the patient involvement in most clinical trial protocols. Sponsors are advised to pursue “patient advisors” who are “individuals with experience living with a disease or condition who may have participated in clinical trials in the past for the same disease with a similar product, but who are themselves not study/research participants for the study they are advising on”. Patient advisors could also be caregivers of patients or representatives from a disease-specific patient organization. The patients with a given disease are the most precious group here. Even though the patient representatives or caregivers may have reasonable perspectives on the disease, the patient has the most direct experience with their disease and will be the target participants of such trials. By requiring that patients who acts as an “advisor” for sponsor prior to trial design be excluded from participating in the same trials, the FDA guidance practically penalizes patients for advising the sponsors. The trials designed with patient perspectives would be very desirable choice for participation by the patients. So long as the patients are treated as any other participants in a clinical trial, it should be permitted to advise on trial design prior to the finalization of the trial protocol. Obviously, patient perspectives are one of the several considerations for a trial design. So, the perceived conflict of interest can be addressed in ways other than excluding patients from participating in the trials. Otherwise, patients would have a tough conundrum, to help a sponsor design a trial and not participate or to not help and hope the trial is still desirable. Caregivers and patient representatives already participate in the design of many clinical trials, but the emphasis of the FDA guidance on patient perspective could be hurt by the conditions proposed. Although the Guidance Document refers specifically to medical devices, the principles described could be applied to all products. Hence this document has a larger impact than intended and should be carefully reviewed for its practical usability.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC