Are you planning the clinical phase for your new therapy and wondering what measures of clinical outcomes have been used successfully for other drugs or biologics? One place to start your research could be the FDA’s Clinical Outcomes Assessments Compendium, which received an update in August. The compendium tables show how certain clinical outcomes assessments (COAs) have been used in clinical trials for reporting patient experience and/or to support labeling claims. The shaded rows mark COAs that have been qualified under the Drug Development Tool Qualification Programs (read more about those programs here). Don’t be put off by the impressive disclaimer on the compendium web page and the FAQ page. These basically point out that the compendium is not the only source of COAs; it is not and doesn’t replace guidance, not all of the necessary information for use is listed, and some of the included COAs may be proprietary and require a license for use. This last point suggests entrepreneurs may find the compendium useful in prompting ideas for new COAs or better tools to administer existing COAs.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2019 Katrina Rogers