December 20, 2018
“Incorporating the patient’s voice and perspective in drug development is critical. Patients can provide key information regarding how well commonly studied endpoints in clinical trials align with outcomes or aspects of disease that matter most to them. Patients living with the disease are the experts on what it’s like to live with the condition. What patients care most about may not always be factored into the endpoints considered in clinical trials or revealed in a product’s approved labeling,” said FDA Commissioner Scott Gottlieb, M.D. “Today we’re issuing draft guidance for stakeholders on how they can develop and submit their own proposed draft guidance relating to patient experience data. Today’s recommendations are part of our commitment to advance patient focused drug development and is one of several guidances that we’re developing regarding the collection of patient experience data and the use of such data and related information in drug development. This guidance document proposes a roadmap for stakeholders who are interested in developing and submitting proposed draft guidance to the FDA relating to patient experience data. It addresses common stakeholder questions and how patient experience data can enhance medical product development and decision-making. It also discusses types of patient experience data and how they may inform the decision making of different types of stakeholders. Submitting a proposed draft guidance for the FDA’s consideration is not the only option to contribute patient experience data and today’s draft guidance also discusses additional potential pathways for contributing patient experience data.”
Today, the U.S. Food and Drug Administration issued draft guidance for industry, Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data. This draft guidance proposes new recommendations for how to develop and submit a proposed draft guidance relating to patient experience data for consideration to the agency.
# # #
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.