June 26, 2019
The Food and Drug Administration (FDA) recently released a new draft guidance entitled, “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry.” As with other clinical trials, inclusion and exclusion criteria in rare disease trials limit who can participate for safety, analysis, or other reasons. Sponsors and researchers struggle with the balance between increasing the chance of detecting real effects of the investigational product an limiting the generalizability of the trial findings. In this new guidance, the FDA recommends that sponsors consider removing inclusion criteria in later phase trials, using enrichment strategies, and increasing supports offered to trial participants. You can read the draft guidance here and enter your comments before August 30th.
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