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# Comments on Clinical Trial Diversity Guidance
- URL: https://www.fdaweb.com/comments-on-clinical-trial-diversity-guidance/
- Published: 2019-08-06T12:00:00.000Z
- Updated: 2026-09-15T01:42:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144705

Hoffman-LaRoche and Genentech say they appreciate that an FDA draft guidance on enhancing the diversity of clinical trial populations takes a multifaceted approach. “However,” the companies’ comment [letter](https://www.regulations.gov/document?D=FDA-2019-D-1264-0052&ref=fdaweb.com) says, “we believe that some of the recommendations provided in the draft guidance could be further expanded or clarified with regard to how to implement the recommendations to address the unique needs of each of the different patient populations.” It also says that to further promote appropriate inclusion of diverse patient populations with regard to age, sex, ethnicity, and genomic ancestry, the companies recommend that the guidance elaborate on the value of embedding inclusivity in early research through genomic ancestry analyses and epidemiological studies.

Pfizer [says](https://www.regulations.gov/document?D=FDA-2019-D-1264-0063&ref=fdaweb.com) the draft “includes helpful recommendations for approaches that sponsors of clinical trials can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their trials. Pfizer also expresses concern that a section of the draft focused on expanded access may be misleading or read to suggest that expanded access programs are not intended for that purpose.

The Biotechnology Innovation Organization (BIO) [says](https://www.regulations.gov/document?D=FDA-2019-D-1264-0056&ref=fdaweb.com) that policy development on the topic requires a more comprehensive approach. “For example,” it says, “broadening eligibility criteria, even if scientifically and technically appropriate, may have profound impact on drug development feasibility and timeliness and, ultimately, patient access to needed treatment options. When the broadening of eligibility criteria is considered, the urgency of addressing an unmet need, the perspectives of patients and caregivers, and the health of the drug development ecosystem in the therapeutic area should be thoroughly considered. BIO encourages FDA to present this drug development and challenge less simplistically in the introduction section of the draft guidance, particularly when robust and effective mechanisms, for example. Use of real-world evidence, are emerging as ways to complement or fill in gaps in knowledge achieved through clinical trials.”