FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Issues First of Four Draft Guidances on Patient-Focused Drug Development

June 14, 2018

Sites and sponsors should have a lot of leeway in determining how to measure patient experiences during drug development but researchers should take care that they’re focusing on the right target population and whatever sampling methods they use are a fair representation of that target population, the FDA said in a new draft guidance.

“Regardless of how individuals are selected into the study, it is important to ensure that patients in the study sample represent the target population, to the greatest extent possible, particularly with respect to the attributes that are associated with the endpoints of interest,” the agency said.

The draft guidance, mandated under the 21st Century Cures Act, is meant to facilitate the advancement and use of systematic approaches to collect meaningful patient and caregiver data that can better inform medical product development. The guidance focuses on sampling methods for patient experiences.

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