Inadequate reporting of COVID-19 clinical studies: a renewed rationale for the Sex and Gender Equity in Research (SAGER) guidelines

Palmer-Ross, Alice; Ovseiko, Pavel V; Heidari, Shirin

doi:10.1136/bmjgh-2021-004997

Cited by 29 publications

(33 citation statements)

References 14 publications

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“…This continuing gender imbalance reflects the gendered nature of the healthcare profession, and not a genderspecific recruitment strategy of the trials. The SAGER Guidelines recommend that future clinical trials design recruitment strategies to include equal representation of women and men from the outset [8,9]. Sex and gender are important variables in clinical research, and are highly relevant in vaccine research.…”

Section: Discussionmentioning

confidence: 99%

“…Recent studies reveal that sex and gender are poorly incorporated into COVID-19 research. A recent review of COVID-19 clinical trials showed poor reporting of sex and gender dimensions, with no justification for the lack of such analysis [9]. Many COVID-19 vaccine trials had not been published at the time of this analysis and were not captured in the previous publication.…”

Section: Introductionmentioning

confidence: 99%

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A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials

2021

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Sex and gender have implications for COVID-19 vaccine efficacy and adverse effects from the vaccine. As vaccination is one of the key responses to the COVID-19 pandemic, it is vital that sex and gender differences be acknowledged, measured, and analysed in clinical research. Here, we systematically review published COVID-19 vaccine trials, both interventional and observational, to assess the quality of reporting of sex and gender. Of the 75 clinical trials on COVID-19 vaccines included in this review, only 24% presented their main outcome data disaggregated by sex, and only 13% included any discussion of the implications of their study for women and men. Considering the sex differences in adverse events after vaccination, and the gendered aspects of vaccine hesitancy, these oversights in clinical research on vaccines have implications for recovery from the COVID-19 pandemic and for wider public health.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials

2021

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“…Medical journals and editors, as well as public health bodies, should redouble their efforts in enforcing recognition of sex/gender in reporting of COVID-19 research ( 65 , 86 ) including enforcement of policies or endorsed guidelines and instructions and advice for peer reviewers…”

Section: Recommendations For Future Immunisation Research and Surveillancementioning

confidence: 99%

Sex and Gender in COVID-19 Vaccine Research: Substantial Evidence Gaps Remain

Vassallo

Shajahan

Harris

et al. 2021

Front. Glob. Womens Health

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Since the start of the COVID-19 pandemic there has been a global call for sex/gender-disaggregated data to be made available, which has uncovered important findings about COVID-19 testing, incidence, severity, hospitalisations, and deaths. This mini review scopes the evidence base for efficacy, effectiveness, and safety of COVID-19 vaccines from both experimental and observational research, and asks whether (1) women and men were equally recruited and represented in vaccine research, (2) the outcomes of studies were presented or analysed by sex and/or gender, and (3) there is evidence of sex and/or gender differences in outcomes. Following a PubMed search, 41 articles were eligible for inclusion, including seven randomised controlled trials (RCTs), 11 cohort studies, eight cross-sectional surveys, eight routine surveillance studies, and seven case series. Overall, the RCTs contained equal representation of women and men; however, the observational studies contained a higher percentage of women. Of 10 studies with efficacy data, only three (30%) presented sex/gender-disaggregated results. Safety data was included in 35 studies and only 12 (34%) of these presented data by sex/gender. For those that did present disaggregated data, overall, the majority of participants reporting adverse events were women. There is a paucity of reporting and analysis of COVID-19 vaccine data by sex/gender. Research should be designed in a gender-sensitive way to present and, where possible analyse, data by sex/gender to ensure that there is a robust and specific evidence base of efficacy and safety data to assist in building public confidence and promote high vaccine coverage.

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“…This lack of focus on sex/gender aligns with findings of a recently published review of COVID-19 clinical trials of drug-based and biological/vaccine interventions, which found that only 18% of trials reported sex-disaggregated results or subgroup analyses (63). Another review published in early 2021 concluded that there was inadequate reporting of sex/ gender in COVID-19 clinical studies, that main outcomes were rarely reported or analysed by sex/gender, and this absence was seldom justified (65). We recognise the challenges in ensuring adequate sample sizes in clinical research to conduct subgroup analyses, particularly when considering rarer adverse events.…”

Section: Reporting Of Sex/gender-disaggregated Datasupporting

confidence: 56%

Data_Sheet_1.pdf

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Inadequate reporting of COVID-19 clinical studies: a renewed rationale for the Sex and Gender Equity in Research (SAGER) guidelines

Cited by 29 publications

References 14 publications

A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials

A Systematic Review of the Sex and Gender Reporting in COVID-19 Clinical Trials

Sex and Gender in COVID-19 Vaccine Research: Substantial Evidence Gaps Remain

Data_Sheet_1.pdf

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