FDA Seeks Feedback on Clinical Outcomes Assessment

With an eye toward patient-focused drug development, the FDA is seeking feedback on a compilation of clinical tools gathered together under a new pilot program.

The clinical outcomes assessment compendium lists diseases and outcome measures and is intended to serve as a central tool for drugmakers developing trials.

Expansive but not exhaustive, the list covers more than 40 pages of outcome examples used in a range of illnesses: from the flu to Alzheimer’s disease, cystic fibrosis and cancer to plaque psoriasis. Descriptions include relevant FDA guidelines, populations studied, context of use and examples of clinical measurements, such as disease-specific patient rating scales.

Taken from CDER’s drug development qualification program, the outcomes — drawn from 2003 to 2014 data — have been tested in clinical trials used in existing labeling.

The agency defines COA as an assessment “that may be influenced by human choices, judgment, or motivation and may support either direct or indirect evidence of treatment benefit.”

The FDA hopes drugmakers can use the compilation as a starting point when considering endpoints for clinical trials.

With its release, the FDA is looking for the industry, academia and patient advocates to discuss how helpful the list is, how best to share information online and guidance on future versions. Comments can be submitted under Docket No. FDA-2015-N-5106.

The current draft of the COA Compendium is at www.fdanews.com/01-13-16-COACompendium.pdf.