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Clinical Outcomes and Endpoints: BIO Comments on Standard Core Sets: Clinical Outcome Assessments (COAs) and Endpoints Grant Program

January 10, 2020

January 4, 2020

Re: Docket No. FDA–2019-N-5157: 2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program.

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks Food and Drug Administration (FDA or Agency) for the opportunity to submit comments following the 2019 Public Meeting on Standard Core Sets: Clinical Outcome Assessments (COAs) and Endpoints Grant Program.

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

BIO commends FDA for its work to coordinate a pilot grant program with the goal of developing publicly available standard core set(s) of COAs and their related endpoints for specific disease indications. BIO appreciates that FDA held the public meeting on December 5, 2019 and sought feedback from various stakeholders through the docket following the public meeting. 

BIO provides additional comments regarding considerations for rigorously developed, fit-for-purpose core COAs and active engagement of patients throughout core set development; development of COAs and endpoints to assess physical/functional status; transparency and communication among stakeholders; global use of COAs; evaluating exiting tools; maintenance of COAs; and selection of disease areas to develop COAs in the future.

Download Full Comments Below
BIO Comments on FDA Public Meeting Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program
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