Drugs

Clinical Trial Diversity Bill Introduced

Reps. Anna Eshoo (D-CA), Brian Fitzpatrick (R-PA), and Robin Kelly (D-IL) have introduced the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act. They say (includes a link to the bill text) the measure is intended to boost diversity in clinical trials by requiring enhanced data reporting on clinical trial demographics and providing resources to improve access to clinical trials.

The bill would:

require IND and IDE applicants to

o report clinical trial enrollment targets by demographic subgroup, and

o provide a diversity action plan detailing steps the sponsor will take to reach the enrollment targets;

provide FDA with the authority to mandate post-market studies when sponsors fail to meet diversity enrollment targets and do not provide sufficient justification;
require FDA to publish an annual report aggregating and analyzing the data provided by sponsors on their progress toward and strategies for improving diversity in clinical trials;
require FDA to hold a workshop to assess how sponsors used the clinical trial flexibilities during the Covid-19 public health emergency and their effect on improving access to clinical trials in underserved populations;
provide funding to the National Institutes of Health for community engagement and outreach efforts to increase inclusion of underrepresented minorities in clinical trials and research; and
provide grant funding to community health centers to increase their capacity to participate in clinical trials and research.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome