3rd Patient-Focused Drug Development Guidance

FDA has published the third of a planned four-guidance series on patient-focused drug development. The latest document, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, covers approaches to selecting, developing, modifying, and evaluating clinical outcome assessments (COAs) to measure outcomes of importance to patients in clinical trials.

It says FDA encourages stakeholders to interact early with the agency and obtain feedback from the relevant review division when considering collecting patient experience data related to the burden of disease and the potential benefits, burdens, and harms of treatment.

The guidance has an Introduction, Overview of COAs in Clinical Trials, A Roadmap to Patient-Focused Outcome Measurement in Clinical Trials, Developing the Evidence to Support the Conclusion That a COA is Appropriate in a Particular Context of Use, References, and five Appendices.