Women widely underrepresented in stroke trial leadership
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An analysis of hundreds of stroke trials shows significantly more men than women were registered as principal investigators from 2011 to 2020, with the most striking difference observed for acute stroke trials, researchers reported.
“An area that has received less scrutiny is the presence of important gender disparities in the leadership of clinical trials,” Sandeep Kumar, MD, associate professor of neurology at Harvard Medical School and a stroke neurologist at Beth Israel Deaconess Medical Center, and colleagues wrote in the study background. “Gender makeup of principal investigators can have a significant influence on the area of investigation of a clinical trial, as well as its design, conduct and interpretation of results. To the best of our knowledge, an estimation of the gender gap in the leadership of clinical trials from North America in the field of stroke has to date not been undertaken.”
Data were derived from Rawlley B, et al. Stroke. 2023;doi:10.1161/STROKEAHA.122.039173.
Data show ‘striking’ gender gap
In a retrospective study, Kumar and colleagues analyzed gender distribution according to academic credentials and trial type for 931 stroke-related clinical trials completed in the U.S. between 2011 and 2020. The researchers also obtained information from Association of American Medical Colleges and the Accreditation Council for Graduate Medical Education data resource books on the gender composition of full-time neurology faculty, neurology residents and vascular neurology fellows. Researchers examined the trend in the annual proportion of women as principal investigators, first authors and last authors during the 10-year period; a similar analysis was conducted for men.
The findings were published in Stroke.
Researchers found gender disparity among the principal investigators, first and last authors persisted over the last decade without any significant trend toward parity (P > .05). Among 821 stroke trials listed on Clinicaltrials.gov, the mean percentage of women vs. men was 38.64% vs. 61.35%, respectively, with no trends in any directions for the annual proportion of women vs. men over 10 years. Similarly, among 110 first authors of stroke trials identified on PubMed, the mean percentage of men vs. women as first authors was 75.53% vs. 24.46%, respectively (P < .001), also with no trends of increase or decrease.
Examining gender distribution according to academic credentials and trial type, researchers found men were overrepresented in the subgroup of principal investigators with an MD degree (78.11% vs. 21.87%; P < .01) and among those leading acute stroke trials (86.04% vs. 13.89%; P < .01).
The researchers also observed a lower proportion of women in neurology residency programs pursued a vascular neurology fellowship during the study period compared with men (33.5% vs. 42.5%; P < .05).
“These findings raise several questions, the foremost being the reasons behind this striking gender gap in stroke trial leadership and its persistence over these years,” the researchers wrote. “Data from last decade show that a lower proportion of women neurology residents pursue a vascular neurology fellowship, leading to a smaller pool of potential women investigators that can subsequently emerge as trial leaders in stroke. Many reasons for this disparity, however, are not exclusive to the stroke field and represents broader, interacting, social cultural factors that have been barriers against women in science as detailed in the extensive National Academy report.”
‘Time for a call to action’
In a related editorial, Silke Walter, MD, professor of neurology at Saarland University in Homburg, Germany, and colleagues wrote the data deliver a clear message: It is “time for a call to action,” to correct an imbalance in leadership for stroke medicine.
“We have failed in attracting and supporting young female medical doctors, not only in becoming clinical trialists and future academic leads, but first and foremost in specializing in stroke medicine,” Walter and colleagues wrote. “Clearly, this cannot be caused by a shortage of young potential. Women represent the majority of medical students in a multicenter analysis conducted in four European countries and also the Association of American Medical Colleges has described similar results in their annual report. However, only little attention is paid on where these prospering young, but female academics get lost on their way to developing their careers.”
Walter and colleagues wrote that trial steering committees should be scrutinized for gender equity by trial sponsors and funding agencies.
“While giving opportunities to women who are already ready now to lead clinical trials, it is important to train the next generation of clinical trial leaders with structured programs to give them the needed competency,” Walter and colleagues wrote.
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