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Women underrepresented in leadership of oncologic randomized clinical trials
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Oncologic randomized clinical trials published between 2003 and 2018 exhibited a low rate of female corresponding authorship in relation to the overall percentage of female academic oncologists during the period, according to a research letter published in JAMA Oncology.
“With increasing representation of women in medicine, recent efforts have attempted to determine whether women are adequately represented among leaders of academic medicine and published studies,” Ethan B. Ludmir, MD, radiation oncologist at The University of Texas MD Anderson Cancer Center, and colleagues wrote. “We studied the representation of female lead authors for oncologic phase 3 randomized clinical trials (RCTs) because trial leadership affects promotion and tenure, prominence in the field, and access to subsequent funding opportunities.”
In their analysis, Ludmir and colleagues analyzed 598 phase 3 therapeutic oncologic RCTs with primary endpoint results published between 2003 and 2018 and adequate author information. Among these trials, 107 (17.9%) had female corresponding authorship (FCA).
The researchers used 2 tests to compare percentages across groups and a linear regression model to assess changes in FCA over time.
Results showed trials funded by industry (n = 465) had lower rates of FCA (14.4% vs. 30.1%; P < .001), whereas cooperative group trials (n = 185) had higher rates of FCA (25.9% vs. 14.3%; P = .001).
In terms of disease site, researchers observed high FCA rates in trials of breast (34.3%; n = 36 of 105) and head and neck cancers (39.1%; n = 9 of 23) and low FCA rates in trials of gastrointestinal (7.9%; n = 6 of 76), genitourinary (7.2%; n = 5 of 69) and hematologic cancers (9.3%; n = 11 of 118).
The researchers also noted associations between FCA and primary treatment modality, with high FCA rates in radiotherapy (31.3%, n = 5 of 16) and supportive care trials (32.7%; n = 37 of 113). Conversely, the seven surgical trials analyzed had no female lead authors.
Trials conducted in the U.S. had a higher FCA rate than those conducted elsewhere (22.5% vs. 12.3%). Based on the date of primary publication, the researchers also observed a significant increase in the rate of FCA over time (r = 0.527; P = .04), with an annual estimated 1.2% (95% CI, 0.1-2.3) increase in FCA that corresponded with an approximately 1% annual increase in female hematologist-oncologists.
“However, the absolute FCA rate for these trials is still lower than the percentage of female academic oncologists in the general study period, ranging from 27% in 2000 to 39% in 2015,” the researchers wrote.
Use of clinicaltrials.gov to identify oncologic RCTs may have resulted in underrepresentation of older trials, trials that do not use systemic therapy, and trials without enrollment or association with the United States, researchers noted. For this reason, they urged caution in interpreting the analyses by treatment modality and geographic location.
“Through identification of the factors associated with gender disparities in RCT leadership, we hope that the academic oncology community will work to better understand and address the underlying reasons for such imbalances,” the researchers wrote. – by Jennifer Byrne
Disclosures: The researchers report no relevant financial disclosures.
Perspective
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Narjust Duma, MD
Supreme Court Justice Ruth Bader Ginsburg once said, “I ask no favor for my sex. All I ask of our brethren is that they take their feet off our necks.”
With the same pledge, many women in medicine continue to reach the highest-ranking seats at universities and medical centers. Since 2017, the number of women enrolling in U.S. medical schools has surpassed the number of men. We have succeeded in getting our women into medical school, but one question remains — are academic and community medicine ready to support and empower these women entering the medical workforce?
The answer to this question is complicated and somewhat controversial.
The NIH has requested an end to panels composed of male investigators only (“manels”) and encouraged inviting more women to the table. Although this initiative is breaking barriers for many women in medicine (including oncology), we should be cautious and avoid “tokenism” — the practice of including women in panels to be compliant with diversity requests instead of giving women a real opportunity and voice at the table.
Ludmir and colleagues’ research brought two critical points to the movement of improving opportunities for women in oncology. First, things are getting better; the authors reported a 1.2% increase in the number of FCAs per year.
Second, given that disparities still exist, phase 3 clinical trials represent a career milestone for many investigators that will subsequently open doors and leadership opportunities for the leaders of the trials. If we are not allowing our women in oncology to lead significant trials, we are holding their academic advancement.
One could argue that the differences observed in this study are secondary to lead-time bias; 10 to 20 years ago, most oncology clinical investigators were men, and these are the senior leaders of the phase 3 trials included in the study. This is undoubtedly true, but how can we explain the differences across oncology subspecialties? Breast cancer trials had the highest representation of FCA compared with other oncology subspecialties, bringing up another question: Are some oncology subspecialties more welcoming to the new generation of female oncologists than others?
The study revealed that industry-funded trials had lower rates of FCA compared with cooperative group trials; the authors attributed this to well-established relationships between male investigators and industry, and potential gender bias. This finding was surprising, and many possible reasons can be hypothesized, including, for example, an age-related bias, as women investigators are younger than their male counterparts, or that a particular male investigator may have an established relationship with industry due to previous trials collaborations.
Lack of women representation in surgical specialties has been documented many times, and, in this study, the researchers observed no FCA in surgical oncology trials. However, this observation should be interpreted with caution, as only seven clinical trials were included in the analysis and may not represent all surgical oncology clinical trials.
The issues encountered by women in medicine and oncology have been documented in several studies over the past 2 decades. It is time to take action to improve the environment for women in medicine and provide them with equal opportunities. As women in medicine, we cannot do this alone; we need the support of our male colleagues —together, we can reduce gender bias in medicine.
References:
Association of American Medical Colleges. 2018 U.S. Medical School Faculty. Available at: www.aamc.org/data-reports/faculty-institutions/interactive-data/data-reports/faculty-institutions/interactive-data/2018-us-medical-school-faculty. Accessed Oct. 17, 2019.
Association of American Medical Colleges. The state of women in academic medicine: The pipeline and pathways to leadership, 2015-2016. www.aamc.org/data-reports/faculty-institutions/data/state-women-academic-medicine-pipeline-and-pathways-leadership-2015-2016. Accessed Oct. 17, 2019.
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