Evaluation of Representation of Women as Authors in Pivotal Trials Supporting US Food and Drug Administration Approval of Novel Cardiovascular Drugs

Shahid, Izza; Khan, Muhammad Shahzeb; Sohail, Aruba; Khan, Safi U.; Greene, Stephen J.; Fudim, Marat; Michos, Erin D.

doi:10.1001/jamanetworkopen.2022.0035

Cited by 8 publications

(17 citation statements)

References 5 publications

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“…The need to ensure balanced recruitment of patients for trials in all disciplines of medicine (and for that matter laboratory animals for pre-clinical research) has given rise to the Sex and Gender Equity in Research (SAGER) guidelines, amongst others ( 33 – 35 ). The phenomenon of female under-representation as clinical trial PIs and academic leaders similarly cuts across all areas of medicine, surgery and medical research ( 36 – 38 ).…”

Section: Discussionmentioning

confidence: 99%

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: Discussionmentioning

confidence: 99%

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

Luong

Aedo-Lopez

et al. 2022

Front. Surg.

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“…This threshold has been validated as particularly stringent by numerous studies. [14][15][16] Ultimately, gender was successfully assigned to 2,798 first authors and 2,762 last authors.…”

Section: Methodsmentioning

confidence: 99%

A Decade of Global Skull Base Researchers: Gender Data from over 2,700 Abstract Authors in the Journal of Neurological Surgery Part B: Skull Base

Hansen

Gold

et al. 2022

J Neurol Surg B Skull Base

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Objective: The North American Skull Base Society (NASBS) annual conference brings together skull base researchers from surgical and non-surgical fields. Our objective was to quantify the contributions of the authors by gender, who presented their work at NASBS and were subsequently published in the Journal of Neurological Surgery Part B: Skull Base. Methods: Oral and poster abstracts presented at the NASBS annual meeting from 01-01-2011 to 12-31-2020 were extracted from the Journal of Neurological Surgery Part B: Skull Base. The genderize.io web application programming interface (API) was utilized to determine authorship gender. A minority of first and last authors had departmental affiliations listed; a subgroup analysis was performed of these authors. Results: Female gender was assigned to 498 (17.8%) of the 2798 first authors and 269 (9.7%) of the 2762 last authors. Female authorship has consistently increased over the last decade. Representation was higher in otolaryngology (23.3% of first authors, 12.1% of last authors; p = 0.018) than neurosurgery (13.5% of first authors, 4.3% of last authors; p = 0.004). Female researchers were not less likely than their male counterparts to receive prestigious oral presentations. Of the 52 total countries represented, 20 (38.5%) had at least one female first author. Representation varied dramatically between countries. Conclusions: The NASBS’ efforts have undoubtedly contributed to these impressive strides toward gender parity. More work is needed to ensure that the best and the brightest, regardless of background, continue to contribute to skull base surgery research.

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“…The authors analyze 53 trial publications, representing 235 331 participants and 26 novel cardiovascular drugs, and observe the overall proportion of women authors to be just 10%. 5 Reading between the lines, these results diminish the hope that disparities in trial leadership are narrowing over time in 2 ways. First, Shahid et al 5 present the proportions of women authors by drug sorted by approval year.…”

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confidence: 99%

“…Elsewhere in JAMA Network Open, Shahid et al 5 and Muquith et al 6 present the results of work examining the representation of women investigators in clinical trials in cardiology and oncology, respectively. They not only redemonstrate the persistence of underrepresentation of women in each field but also identify deficiencies and opportunities for improvement that may have eluded prior, more general analyses.…”

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confidence: 99%

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Women and Leadership of Cardiology and Oncology Clinical Trials—Swimming Against the Tide

Moin

Reza

2022

JAMA Netw Open

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Evaluation of Representation of Women as Authors in Pivotal Trials Supporting US Food and Drug Administration Approval of Novel Cardiovascular Drugs

Cited by 8 publications

References 5 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

A Decade of Global Skull Base Researchers: Gender Data from over 2,700 Abstract Authors in the Journal of Neurological Surgery Part B: Skull Base

Women and Leadership of Cardiology and Oncology Clinical Trials—Swimming Against the Tide

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