Clinical Outcome Assessments: FDA Seeks Feedback

Regulatory NewsRegulatory News | 02 August 2018 |  By 

As patient experiences provide new insights for FDA reviewers, the agency is looking for feedback on how to better coordinate clinical outcome assessments (COAs) across different disease types.

Since 2012, FDA has conducted patient-focused meetings in different disease areas to hear directly from patients about the impact of disease on their daily life and the burden of current treatments. But separate, independent efforts by different patient advocacy groups and drug sponsors within and across disease areas are resulting in a diversity of measures and proprietary COA tools, FDA explains.  

“Repeated significant start-up costs and varying levels of experience among sponsors, advocacy groups and the consultants they may engage may lead to variable quality in the resulting COA-related endpoints,” the agency said.

Now, FDA is interested in identifying the diseases and treatment impacts that matter most to the people living with the disease or condition.

“FDA is not only interested in the high-level concepts (e.g., pain, fatigue) related to those impacts but also interested in the set of specific measures and tools and exact endpoints that are proposed to be used for a given disease,” the agency said.

The agency lays out 14 different questions with specifics on developing COAs. Those interested in offering comments have until 15 October.

FDA Standard Core Clinical Outcome Assessments and Endpoints


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