Patient Experience Data: FDA Drafts Guidance

Regulatory NewsRegulatory News | 20 December 2018 |  By 

Thanks to the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Thursday published new draft guidance to help stakeholders submit a proposed draft guidance on patient experience data.

The 12-page draft guidance, which provides information in a Q&A format, addresses questions relating to both guidance development and other potential pathways for contributing patient experience data.

“Today’s guidance document is 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,” FDA Commissioner Scott Gottlieb said. “This guidance document proposes a roadmap for stakeholders who are interested in developing and submitting proposed draft guidance to the FDA relating to patient experience data.”

When is it appropriate to develop a proposed draft guidance? FDA offers three specifics: If FDA has issued a clinical guidance for a given disease but the guidance does not address considerations for a specific subpopulation; if FDA has issued a methodological guidance that applies to a range of disease areas but the guidance does not provide specific examples of how the methods can be applied to a specific disease or subpopulation; and if FDA has not issued a clinical guidance in a disease area but there is a need for disease-specific guidance to address patient experience data.

Symptoms, the impact of a condition on quality of life, treatment experience, the importance of outcomes and preferences for outcomes and treatments are all discussed and considered part of what can be collected as patient experience data.

“A proposed draft guidance should be formatted so that it provides clear and concise recommendations for FDA to consider should FDA develop a guidance on the topic, and should not give the impression that it is an FDA-drafted document,” the draft says.

As far as other opportunities to share patient experience data, the draft discusses developing a patient registry, conducting natural history studies, coordinating work among patient groups, convening meetings and communicating, educating and conducting outreach.

Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data Guidance for Industry and Other Stakeholders


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