SIR 2024
General IR
Nicole Keefe, MD (she/her/hers)
Assistant Professor, Program Director
University of North Carolina at Chapel Hill
Financial relationships: Full list of relationships is listed on the CME information page.
Marlee Croissy, MD
Independent Resident
University of North Carolina at Chapel Hill
Disclosure information not submitted.
Gloria Salazar, MD (she/her/hers)
Vice Chair Diversity and Health Equity
UNC
Financial relationships: Full list of relationships is listed on the CME information page.
Many clinical studies do not reflect the true patient population of the disease pathology making studies less applicable and generalizable than desired. The ELEGANCE patient registry seeks to improve diverse patient enrollment in the peripheral artery disease (PAD) population. PAD is not the only disease affected by this enrollment disparity. Several methods have been proposed for improving diverse patient enrollment. This study focuses on evaluating the gender of the primary and secondary investigators (PI, sub-I) in a clinical trial and the ability to enroll a gender diverse population more reflective of the background population.
Materials and Methods:
Seven consecutive completed trials performed from 2018 to current by a single device company were evaluated for percent female PI and sub-PI and female enrolled. No trials were excluded. Trial topics included acute coronary syndrome, pulmonary embolism, ischemic stroke, acute limb ischemia (ALI) and cerebral aneurysm. This was compared to the average percent female patients enrolled in clinical trials documented as completed with more than 10 enrolled sites and more than 50 patients in the United States. This was further compared against the background population gender proportion of the disease pathology quoted in the existing literature.
Results:
As the number of female PI and sub-I’s increased, the percent female enrolled also increased in relation to trials of the same disease pathology (r=0.71, p=0.071). In particular, there exists a large gap in the females enrolled for ALI trials, which was vastly improved by increasing female investigators in comparison to other studies. With the exception of the PAD study, there exists a trend towards an increased number of females enrolled (r=0.83, p=0.042), even above the background disease population.
Conclusion:
Gender diversity of clinical investigators can aid to improve the gender diversity of the subject population. This may allow clinical trials to become more reflective of the background population and may be applicable to racial diversity as well. Further study is needed to evaluate if this trend holds for other disease pathologies and clinical trials where PI gender information is available. As physicians, it is our responsibility to enroll a racially and gender diverse study population that is reflective of the background population. Investigator diversity may be the key to improving trial diversity.