Demographic Disparities in FDA Oncology Trial Participants, 2018-2024

329 pivotal clinical trials enrolling over 164,000 participants form the basis for this analysis of representation in FDA oncology drug approvals. The dataset quantifies underrepresentation of women, racial and ethnic minorities, and older adults using Enrollment Incidence Ratios. Hao Cheng published the study on figshare in May 2026 under a CC-BY-4.0 license.

Use Cases

• Analyze trends in demographic representation over time based on the 2018-2024 study period
• Assess the impact of trial-level factors like industry sponsorship or accelerated approval on enrollment disparities
• Evaluate the effect of the COVID-19 pandemic on participant representation in oncology trials
• Benchmark enrollment figures against population-based estimates from SEER 21 data

Strengths

• Includes data from 329 trials and over 164,000 participants
• Calculates specific Enrollment Incidence Ratios (EIRs) with confidence intervals for demographic groups
• Systematically identifies trials using the FDA Hematology/Oncology Approvals database

Limitations

• Column-level documentation is absent; field semantics must be inferred after download
• Row count is unknown, which may limit suitability assessment
• The dataset is stored in a DOCX file (577.6 KB), which may require extraction of underlying data

Provenance

Source

FDA Hematology/Oncology Approvals database and SEER 21 data

Collection Method

Systematic identification and extraction of demographic data from pivotal trials supporting FDA oncology drug approvals

Time Range

January 2018 through November 2024

Freshness

Last updated 2026-05-01 04:19:02

Geography

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