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An Evaluation of Novel Oncology Approvals with a PMR/C for Assessing Data in Racial and Ethnic Populations
Grace Collins1, Hillary S Andrews1, Brittany McKelvey1
1Friends of Cancer Research, Washington, District of Columbia.
Abstract:
Clinical trials supporting oncology drug approvals frequently underrepresent diverse racial and ethnic populations. Recent policies have focused on ensuring premarket clinical trials are more inclusive and representative of racial and ethnic diversity in the general U.S. population or intended patient population; however, recent U.S. Food and Drug Administration (FDA) guidance on postmarketing approaches to collecting data in underrepresented populations demonstrates that, in certain circumstances, postmarketing requirements and/or commitments (PMR/Cs) may be issued to conduct more representative studies if there are remaining questions about safety or efficacy. This analysis demonstrates that prior to 2020, no drugs had PMR/Cs to further characterize use in a more representative population, and in the last 3 years, more than half of novel oncology approvals have had such a PMR/C (21/40, 53%). In addition, this analysis helps to identify characteristics, such as single-arm pivotal trial design, U.S. enrollment, and results of safety subgroup analyses based on race and ethnicity, that may contribute to decisions to issue a PMR/C to conduct a study that is more representative of the racial and ethnic diversity of the U.S. or intended patient population. These results can inform efforts to improve premarket clinical trials to ensure they are representative and able to characterize use in any patient who may need the drug.
Insights
Clinical trials for cancer drugs often lack diversity. Recent policies aim for inclusivity, but postmarketing requirements (PMR/Cs) are increasingly used by the FDA to ensure representative data for oncology drug safety and efficacy.
Area of Science:
- Oncology
- Clinical Trial Design
- Health Equity
Background:
- Premarketing clinical trials for oncology drugs often underrepresent racial and ethnic populations.
- Recent policies aim to improve diversity in premarket trials.
- U.S. Food and Drug Administration (FDA) guidance allows for postmarketing requirements and/or commitments (PMR/Cs) to address data gaps in underrepresented groups.
Purpose of the Study:
- To analyze the trend of issuing PMR/Cs for oncology drugs to ensure more representative patient populations.
- To identify factors associated with the decision to issue PMR/Cs for postmarketing studies.
Main Methods:
- Analysis of oncology drug approvals and associated PMR/Cs issued by the FDA.
- Examination of trial characteristics, including trial design, enrollment location, and safety subgroup analyses.
Main Results:
- Prior to 2020, no oncology drugs had PMR/Cs for representative populations.
- In the last three years, 53% (21/40) of novel oncology approvals received a PMR/C for more representative studies.
- Factors like single-arm pivotal trials, U.S. enrollment, and safety subgroup analyses may influence PMR/C issuance.
Conclusions:
- There has been a significant increase in the use of PMR/Cs for oncology drugs to address racial and ethnic diversity.
- These findings can guide improvements in premarket trial design to enhance representativeness.
- Ensuring diverse patient data is crucial for characterizing oncology drug use across all populations.
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