Friends of Cancer Research characterized postmarketing requirements and commitments over the last decade. The perspective article, titled “An evaluation of novel oncology approvals with a PMR/C for assessing data in racial and ethnic populations underrepresented in premarket clinical trials,” provides insights into FDA’s expectations for representation of race and ethnicity in oncology clinical trials.
“This research shows that prior to 2020, no approved drugs had race or ethnicity related PMR/C, while in the last three years, more than half of novel oncology approvals have had such a PMR/C (21/40, 53%),” co-author Jeff Allen, president and CEO of Friends, said in a statement. “We hope the results from this study help demonstrate the importance for collecting these data and can inform future trial designs to better characterize use in a more representative population.”
The article was published in Clinical Cancer Research. The manuscript is the second in a series of Friends’s publications evaluating PMR/Cs issued over the last decade.
“Additionally, we observed that certain approval characteristics 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,” first author Grace Collins, regulatory policy analyst at Friends, said in a statement.
This publication provides important insights about strategies for ensuring clinical trials are more inclusive and representative of the intended patient population and general U.S. population.
Friends established a PMR/Cs dashboard using data from publicly available approval letters and review documents in FDA’s database, serving as the basis for the data analyzed in this publication. The dashboard displays data on PMR/Cs issued at the time of initial approval for novel oncology therapies between Jan, 1, 2012, and Dec. 31, 2023.
