Article

The Dearth of Representation in FDA Approved Drug Trials

2024-01-17

Abstract excerpt

The generalizability of data derived from randomized controlled trials is of paramount importance given their utility in the Food & Drug Administration (FDA) drug approval process. An essential part of this process is the inclusion of reliably reported gender, race and ethnicity data in trials that lead to FDA drug approval. Despite previous mandates by the FDA and Clinicaltrials.gov , gender and race-specific dat...

Topics

Open a Topic to create a Post that cites this publication.

Identifiers and source

Literature Corpus work: af639379-5e18-59fa-93b8-24cb7aef9792
DOI: 10.1101/2024.01.16.24301376

Open publication

Related research

Semantic proximity does not establish scientific evidence.

Click a neighbor to travelStep 1 · 12 closest

The Dearth of Representation in FDA Approved Drug TrialsDOI 10.1101/2024.01.16.24301376Read

New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA Approved Drugs and BiologicsSemantic proximity Read

Racial and Ethnic Diversity in Clinical Studies Reported to ClinicalTrials.gov, 2009-2024Semantic proximity Read

Sex Representation in U.S. Clinical Trials: A Statistical Benchmarking StudySemantic proximity Read

Culture, ethnicity, and medications.Semantic proximity Read

Characteristics and data reporting of rare disease clinical trials: Getting better but still room for improvementSemantic proximity Read

Are women underrepresented in cerebrovascular disease clinical trials? A systematic review using the FDA databaseSemantic proximity Read

23andMe and the FDA.Semantic proximity Read

Genetics. FDA races in wrong direction.Semantic proximity Read

Evaluation of potential adverse effects of gender-affirming hormonal therapy; findings from the Spanish Pharmacovigilance System DatabaseSemantic proximity Read

Comparison of Clinical Evidence Submitted to the FDA and EMA for Cell and Gene TherapiesSemantic proximity Read

Eligibility for Human Leukocyte Antigen-Based Therapeutics by Race and Ethnicity.Semantic proximity Read

Investigating Racial Disparities in Drug Prescriptions for Patients with EndometriosisSemantic proximity Read