Trends and geographic variation in women's representation as principal investigators (PI) in phase 3 gynecologic oncology clinical trials

Jou, Jessica; Brodsky, Allison; Charo, Lindsey; Binder, Pratibha; Saenz, Cheryl C.; Eskander, Ramez N.; McHale, Michael; Plaxe, Steve

doi:10.1016/j.ygyno.2021.05.037

Cited by 8 publications

(13 citation statements)

References 19 publications

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“…There was a higher percentage (still less than 50%) for breast and gynecological cancers ( 39 , 40 ). Jou et al reported a 3% rise annually in female PIs within phase 3 gynecological clinical trials from 2010 to 2020 internationally and as in our study, women were more likely to be leading trials with multiple co-PIs than with one PI ( 41 ).…”

Section: Discussionsupporting

confidence: 68%

Gender profile of principal investigators in a large academic clinical trials group

Luong

Aedo-Lopez

et al. 2022

Front. Surg.

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IntroductionGender equity in medicine has become a significant topic of discussion due to consistently low female representation in academia and leadership roles. Gender imbalance directly affects patient care. This study examined the gender and craft group of the Principal Investigators (PI) of clinical trials run by the Australasian Gastro-Intestinal Trials Group (AGITG)MethodsPublicly available data was obtained from the AGITG website. Trials were divided into upper, lower gastrointestinal cancer, miscellaneous (neuroendocrine and gastrointestinal stromal tumours). Where multiple PIs were listed, all were counted. Craft group was assigned as surgical, medical, radiation oncology or other.ResultsThere were 69 trials with 89 PI, where 52 trials were represented exclusively by male PIs. Of all PIs, 18 were women (20.2%); all were medical oncologists. Prior to 2005, all PIs were male. The craft group distribution of PIs was: 79% medical oncologists, 12% surgical oncologists, 8% radiation oncologist, 1% nuclear medicine physicians. Regarding trials with multiple PI's, there were 19 in total. Of these, 11 had only male PIs, which included 5 surgeons. Females were more likely to be a co-PI (42%) as opposed to sole PI (18%). There was no gender policy publicly available on the AGITG website.ConclusionsThere is a low percentage of female PIs in academic oncology trials in the portfolio of this large international trials group. No trial was led by a female surgical or radiation oncologist. There is a need to understand the reasons driving the disparity so that specific strategies can be put in place.

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Section: Discussionsupporting

confidence: 68%

Gender profile of principal investigators in a large academic clinical trials group

Luong

Aedo-Lopez

et al. 2022

Front. Surg.

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“…One study evaluating oncology clinical trials from 1999 to 2019 found a similar distribution with the proportion of women principal investigators higher in North America (31%) and Europe (24%) than in Asia (15%) [34]. Similarly, a study evaluating Phase III gynecological oncology trials from 2010 to 2020 found that women were approximately two times more likely to lead clinical trials outside of Asia [16]. Our analysis also found no substantial difference in the proportion of women principal investigators in clinical trials stratified by US Census region.…”

Section: Discussionmentioning

confidence: 94%

“…We conducted Fisher exact tests to evaluate differences in gender proportions based on the included clinical trial characteristics. Similar to previous analyses, we applied univariate linear regression to analyze trends in the annual proportion of women principal investigators over time [1, 16, 19]. We chose this statistical analysis based on the expectation of linear trends in increased gender diversity as efforts to raise awareness and address the lack of gender diversity continue.…”

Section: Methodsmentioning

confidence: 99%

“…Additionally, trials that selected not applicable for the study phases were included to capture trials of orthopaedic devices or behavioral interventions. Per previous methods [8,16], trials without a designated phase or those that listed organizations (such as, Pfizer) as the principal investigator or provided empty or ambiguous principal investigator names (that is, names with low probability of gender prediction (detailed in Determination of PI Gender) were excluded. A total of 3246 orthopaedic clinical trials remained after the selection process (Fig.…”

Section: Clinical Trial Selectionmentioning

confidence: 99%

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What Are the Trends in Women’s Representation Among Lead Investigators of Orthopaedic Clinical Trials?

Burkhart

Karimi

Hecht

et al. 2023

Clin Orthop Relat Res

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Background Serving as a principal investigator for a clinical trial can bring national visibility and recognition to physicians, and it can have a substantial impact on their promotion and tenure. In the field of orthopaedics, there is a well-known gender gap in terms of representation and leadership. Examining the representation of women in clinical trial leadership may help to inform and enable the design of targeted interventions and policies to foster a more inclusive and diverse environment in clinical trial leadership. Questions/purposes (1) What is the proportion of women principal investigators in orthopaedic clinical trials, and has this changed over time? (2) Are there trial characteristics (trial phase, status, funding source, and intervention) associated with women principal investigators? (3) What is the geographic distribution globally and regionally within the United States of clinical trials led by women principal investigators? Methods A cross-sectional survey of clinical trials using the ClinialTrials.gov registry and results database provided by the NIH was performed on August 22, 2022. Trial characteristics included principal investigator names and gender, trial phase, type, funding source, intervention, and location (defined by continent and US Census region). Our primary outcome was the overall proportion of women orthopaedic principal investigators over time. We assessed this by comparing the proportion of women principal investigators from 2007 to 2022. Our secondary outcomes were trial characteristics (trial phase, status, funding source, and intervention) and geographic distribution (globally and within the United States) associated with women principal investigators. Baseline characteristics of the clinical trials were calculated using frequencies and percentages for categorical variables. Fisher exact tests were conducted to evaluate differences in gender proportions based on the included clinical trial characteristics. Univariate linear regression was applied to analyze trends in the annual proportion of women principal investigators over time. Results The overall proportion of women principal investigators was 18% (592 of 3246), and this proportion increased over the study period. Specifically, the proportion of women leading clinical trials was 13% (16 of 121) in 2007 and 22% (53 of 242) in 2022 (r2 = 0.68; p < 0.001). This trend was also observed when evaluating only US women principal investigators (r2 = 0.47; p = 0.003) and non-US women principal investigators over the study period (r2 = 0.298; p = 0.03). There was no difference in the distribution of trial phases between men and women principal investigators. Most men and women were involved in “not applicable” or Phase IV trials. Similarly, there was no difference in trial status or funding source. However, women principal investigators had a higher proportion of studies involving behavioral interventions (11% [67 of 592]) compared with men principal investigators (3% [74 of 2654]; p = 0.03). The proportion of women principal investigators over the study period by world region revealed a higher proportion of women principal investigators in Asia (23% [88 of 391]), followed by South America (24% [12 of 49]), North America (18% [306 of 1746]), and Europe (16% [136 of 833]). Among all US trials over the study period, the proportion of women principal investigators across the US Census region was Northeast (19% [62 of 329]), South (18% [90 of 488]), West (20% [97 of 492]), and Midwest (13% [22 of 168]). Conclusion Although there has been a notable increase in the proportion of women principal investigators over time, the overall representation remains relatively low. The disparities observed in trial characteristics and geographic distribution of women principal investigators further emphasize the need for targeted interventions and policies to foster a more inclusive and diverse environment in clinical trial leadership. Clinical Relevance These results underscore the importance of adopting practices and strategies that foster gender equity in the leadership of orthopaedic clinical trials. By establishing mentorship and sponsorship programs, early-career women surgeons can be connected with experienced leaders, cultivating a supportive network and offering valuable career guidance. Additionally, addressing geographic disparities in the representation of women principal investigators can involve the implementation of mentorship and sponsorship programs in regions with lower representation.

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“…7,8 In gynecologic oncology (GO), when gender equality is concerned, it was recently shown that the number of female first authors in published manuscripts has increased markedly, 6 and that women's representation as primary investigators in clinical trials has increased in the last decade. 9 Little is known regarding the representation of women in international and national leadership positions in professional medical societies in recent years, 10 and in GO these data are under-reported.…”

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confidence: 99%

Gender leadership in gynecologic oncology professional societies worldwide

Cohen,

Alter,

Meyer

et al. 2023

Intl J Gynecology & Obste

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ObjectiveWe aim to study gender representation among the different national gynecologic oncology (GO) societies' presidents over the past decade.MethodsA cross‐sectional study examining the period 2013–2022. The leadership positions in 11 GO societies in the USA (SGO), internationally (IGCS), Europe (ESGO), Australia (ASGO), Israel (ISGO), Japan (JSGO), Asia‐Oceania (AOGIN), India (INSGO), Latin America (SLAGO), South Africa (SASGO), and Turkey (TRSGO) was studied. The proportion of leadership positions held by women was calculated and trends were evaluated.ResultsOverall, the average rate of women's representation during the study period was 26.4%, and for the different organizations was: SASGO 70.0%, SGO 50.0%, ESGO 40.0%, ASGO 30.0%, INSGO 30.0%, and IGCS, ISGO, and SLAGO 20.0% each, TRSGO 10%, and no representation of women in JSGO and AOGIN. There was a significant decrease from 2013 to 2016 (63.6% to 9.1%) (P = 0.009) in women's representation as presidents of societies. From 2017 to 2022, there was no difference in women's representation (ranging from 9.1% to 36.4%) (P = 0.13).ConclusionsThis study demonstrates that women are significantly under‐represented in leadership positions in GO professional societies; however, in South Africa and the USA their representation in the last decade was close to equality.

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Trends and geographic variation in women's representation as principal investigators (PI) in phase 3 gynecologic oncology clinical trials

Cited by 8 publications

References 19 publications

Gender profile of principal investigators in a large academic clinical trials group

Gender profile of principal investigators in a large academic clinical trials group

What Are the Trends in Women’s Representation Among Lead Investigators of Orthopaedic Clinical Trials?

Gender leadership in gynecologic oncology professional societies worldwide

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