September 26, 2019

New Guidance Seeks to Allow Patients to Shape Clinical Trials for Medical Devices

The FDA released draft guidance that recommends allowing patients to help design clinical investigations for medical devices. Patient advisors would have experience with the disease or condition that the medical device is being developed to treat. Such advisors would be prohibited from participating in clinical trials on which they advised. Rather, they could potentially participate in activities related to the trial, such as creating clearer informed consent documents, suggesting ways to ease the burden associated with follow-up visits, and ensuring that the investigators understand which outcomes are most important to the patients.

The FDA hopes that patient participation will mitigate challenges with study enrollment and ensure that the trial design takes into consideration some of the hardships that patients might face when participating in these studies.