A Step Toward Increasing Patients’ Voices in Clinical Trials

July 8, 2020
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The Cancer Support Community (CSC) welcomes the FDA’s new pilot program, Project Patient Voice, as a thoughtful first step toward the development of a comprehensive and consistent method of sharing patient experience data (PED) collected in clinical trials with patients and providers to help inform treatment decisions. For years, the CSC has been in conversations with the FDA on the importance of collecting PED and specifically, in incentivizing manufacturers to examine PED through a pilot program. We are very encouraged to see the agency pursue this opportunity and are eager to work with interested stakeholders to make the project a success.

The patient-reported symptom data that will be collected in the pilot, specifically symptomatic adverse event data, represents just one type of data from one source of PED. CSC looks forward to continuing our discussions with the FDA and drug manufacturers to ultimately expand the Project Patient Voice to include the collection and sharing of the full scope of PED that captures not just adverse symptoms, but also patients’ experiences, perspectives, needs, and priorities. This pilot presents a unique opportunity to obtain public feedback not only on the usability of the website, but also on what additional types of information stakeholders believe can and should be collected that only patients enrolled in clinical trials can provide. 

CSC appreciates the FDA’s forward thinking on developing a new approach to sharing patient generated data not otherwise included on the drug label. We are eager to continue our collaboration with the FDA, industry, patients, and providers to fully honor Congress’ recognition of the importance of PED through its passage of the 21st Century Cures Act in 2016 and the Food and Drug Administration Reauthorization Act (FDARA) in 2017. 

The consistent collection, use, and sharing of meaningful patient experience data will allow us to better understand and address the full range of patient needs and concerns which will, in turn, improve the shared decision-making process both for the benefit of the patient and their family, as well as for future clinical trial design.