Biologics

Fit-For-Purpose Clinical Outcome Assessment Guidance

FDA has published a draft guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, the third in a series of four methodological patient-focused drug development guidances that describe how stakeholders such as patients, caregivers, researchers, medical product developers, and others, can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. This document includes approaches to selecting, modifying, developing, and validating clinical outcome assessments (COAs) to measure outcomes of importance to patients in clinical trials.

The guidance says the agency encourages stakeholders to interact early with FDA and obtain feedback from the relevant agency review division when considering the collection of patient experience data related to the burden of disease and treatment. The agency also recommends that stakeholders engage with patients and other relevant subject experts when designing and implementing studies to evaluate the burden of disease and treatment, and perspectives on treatment benefits and risks.

The contents of the guidance are 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, Abbreviations, Useful References for Selecting, Modifying, and Developing Clinical Outcome Assessments, and five Appendices.

When finalized, the guidance will represent the thinking of CBER, CDER, and CDRH.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome