Missing Data Hinders Inclusion Of Patient Experience In Drug Labeling, US FDA Says
Agency staff note hurdles in obtaining evidence outlined in FDA’s patient-focused drug development guidance to support regulatory decision-making.
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Patient-Focused Drug Development Guidance: Determining When A Clinical Outcome Assessment Is Appropriate
A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular context.
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.
Following stakeholder criticism of an earlier discussion paper, draft guidance does not automatically foreclose use of social media data as the primary source of qualitative research; however, agency says entities submitting such data for regulatory review must ensure rigor in methodology and data integrity.