1. Pink Sheet

US FDA's Patient Experience Data Guidance Calls More Attention To Burdens Of Surveys

 
• By Sue Sutter

Patient-focused drug development final guidance is little changed from 2019 draft but urges that quantitative data collection methods for issues important to patients need to easily usable by individuals with different abilities and cultural backgrounds.

Focus lens
An FDA PFDD final guidance puts more focus on the accessibility and burden of quantitative data collection for patients. • Source: Alamy

New language in the final version of a US Food and Drug Administration guidance on patient-focused drug development emphasizes a more patient-centric view about the burdens of collecting survey data, and ensuring such questions are accessible to those with disabilities and in a culturally appropriate language.

The guidance, “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients,” is the second in a series...

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