Washington D.C., July 1, 2024- The Food and Drug Administration (FDA) unveiled a draft guidance document, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” which is open for public comment. This draft guidance points to improving participation from people who are traditionally underrepresented in clinical trials.
John Dwyer, President of the Global Alzheimer’s Platform Foundation said:
“We are encouraged by the FDA’s updated draft guidance, as improving representation in clinical research is at the core of our work at GAP. We have been and continue to be dedicated to addressing the barriers that many face when accessing clinical trials, especially people who have been traditionally underrepresented. GAP’s Inclusive Research Initiative (GAP-IRI) is making a difference, proving that intentional efforts to be inclusive result in increased participation and this needs to be the new standard. Our inaugural study, Bio-Hermes-001, had an unprecedented 24% of participants from diverse communities. We welcome the dialogue this draft guidance will spark and look forward to a brighter future for clinical research where all are represented.”