posted on August 07, 2019
The US COPD Coalition (USCC) has submitted comments in support of the Food & Drug Administration (FDA) draft guidance for industry entitled, “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs”.
The USCC believes that these recommendations are an important step forward in having the groups of patients studied in clinical trials more accurately reflect the diversity of patients who may benefit from the treatments being trialed. The US COPD Coalition strongly supports the adoption of the Enhanced Diversity Draft Guidance. Valerie Chang, JD, Vice-Chair of the USCC Board of Directors was the primary author of the comments that were submitted to the FDA. "This is something I feel is long overdue, in recognition of the very diverse country we have in the US--this would try to have more diverse populations representated in clinical trials", Chang noted.
American Indians/Alaska Natives, multiracial individuals, and non-Hispanic blacks have a disproportionately high rate of COPD compared to whites. Still, most COPD studies are of white and black adults, including the very large COPDGene study with over 10,000 patients. USCC believes that the Enhanced Diversity guidelines will result in greater diversity of study subjects, which will be more representative of the wider population afflicted with COPD.
Click the link below to see the letter submitted to the FDA: