Targeted site selection could improve the marked underrepresentation of minority participants in coronary stent trials, but improving female enrollment requires alternative strategies.
Observational (n=8,859)
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Do site characteristics predict enrollment of demographic minority and female participants in coronary stent PMA trials?
Targeted site selection could improve minority representation in coronary stent trials, but alternative strategies are needed to improve female enrollment.
valor p: p=<0.001
BACKGROUND: Class III cardiovascular device premarket approval (PMA) studies often fail to fully represent the intended-use population (IUP) owing to low enrollment of racial and ethnic minority subjects and women. The impact of research site selection on this is unknown. OBJECTIVES: In this study, we sought to determine if site characteristics predict enrollment of demographic minority and female participants in coronary stent PMA trials and evaluate if site selection could improve representation of the IUP. METHODS: We pooled data from 8,859 U.S. participants enrolled in 9 pivotal coronary stent PMA studies (2003-2018) across 196 sites. Site characteristics included U.S. region, surrounding county demographics, teaching status, Veterans Administration affiliation, trial volume, female principal investigator (PI) involvement, and number of acute hospital beds. Multivariable regression identified predictors of minority and female enrollment. Participant-to-prevalence ratios (PPRs) were modeled under varying site selection scenarios. RESULTS: = 0.095; P < 0.001); however there were few female PIs (<6%), limiting correlation. CONCLUSIONS: Coronary stent PMA studies do not fully reflect the IUP, owing to marked underrepresentation of minority participants and modest underrepresentation of women. Because minority enrollment is influenced by site characteristics, targeted site selection could improve representation; however, improving female enrollment requires alternative strategies. These insights have implications on the planning and design of future cardiovascular device trials.
“A site selection strategy that accounts for regional and county-level demographics may normalize minority representation without compromising that of non-Hispanic Whites. However, the effect on enrollment of women would be minimal, underscoring the need for additional targeted interventions to enhance representation of women in cardiovascular device trials.”
Batchelor et al. (Tue,) conducted a observational in Coronary artery disease (n=8,859). Targeted site selection could improve the marked underrepresentation of minority participants in coronary stent trials, but improving female enrollment requires alternative strategies.
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