Clinical Trial Diversity Requires Community-Based Research Infrastructure, US FDA’s Woodcock Says
COVID-19 trials could have reached underserved populations better if research infrastructure was in place where people routinely get their health care, acting commissioner Janet Woodcock says; PhRMA is looking to establish a public-private partnership that would build a sustainable community-based infrastructure for clinical research.
You may also be interested in...
Pfizer and Genentech execs describe steps they’ve taken to increase diversity in clinical trials from moving trial sites into new neighborhoods to modifying protocols and holding others accountable for diversity.
Although differences in how sponsors have publicly disclosed demographic data for their enrolled trials make cross-study comparisons difficult, in general trial enrollment of Black and Hispanic participants has ranged from 10%-19% and 11%-45%, respectively, with one-quarter to one-third of study subjects falling into older age groups.
Industry principles for enhancing diversity in clinical trials call for use of digital data collection tools and flexible scheduling of study site visits to reduce barriers to enrollment, as well as greater involvement of under-represented communities in the trial design planning process and recruitment of investigators with diverse ethnic and racial backrounds.