Lack of consideration of sex and gender in COVID-19 clinical studies
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Abstract
Sex and gender differences impact the incidence of SARS-CoV-2 infection and COVID-19 mortality. Furthermore, sex differences influence the frequency and severity of pharmacological side effects. A large number of clinical trials to develop new therapeutic approaches and vaccines for COVID-19 are ongoing. We investigated the inclusion of sex and/or gender in COVID-19 studies on ClinicalTrials.gov, collecting data for the period January 1, 2020 to January 26, 2021. Here, we show that of the 4,420 registered SARS-CoV-2/COVID-19 studies, 935 (21.2%) address sex/gender solely in the context of recruitment, 237 (5.4%) plan sex-matched or representative samples or emphasized sex/gender reporting, and only 178 (4%) explicitly report a plan to include sex/gender as an analytical variable. Just eight (17.8%) of the 45 COVID-19 related clinical trials published in scientific journals until December 15, 2020 report sex-disaggregated results or subgroup analyses.
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SciScore for 10.1101/2020.09.13.20193680: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization We only analyzed original publications of randomized controlled trials. Blinding not detected. Power Analysis not detected. Sex as a biological variable We identified attention to sex/gender in the trial design phase by searching the study protocol registration fields – title, brief summary, detailed description, eligibility criteria descriptions and (primary, secondary, other) outcome measures – for the following terms (and their plurals): sex, gender, woman, female, man, male, girl, boy, pregnan*, HRT, hormone replacement therapy, estrogen, progesterone, testosterone and transg*. Table 2: Resources
Software and Algorithms Sentences Resources We… SciScore for 10.1101/2020.09.13.20193680: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization We only analyzed original publications of randomized controlled trials. Blinding not detected. Power Analysis not detected. Sex as a biological variable We identified attention to sex/gender in the trial design phase by searching the study protocol registration fields – title, brief summary, detailed description, eligibility criteria descriptions and (primary, secondary, other) outcome measures – for the following terms (and their plurals): sex, gender, woman, female, man, male, girl, boy, pregnan*, HRT, hormone replacement therapy, estrogen, progesterone, testosterone and transg*. Table 2: Resources
Software and Algorithms Sentences Resources We searched the PubMed database on June 2, 2020 for publications on SARS-CoV-2/COVID-19 trials using the following search terms: “covid-19”[tw] AND trial[ti]. PubMedsuggested: (PubMed, RRID:SCR_004846)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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SciScore for 10.1101/2020.09.13.20193680: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization We only analyzed original publications of randomized controlled trials. Blinding not detected. Power Analysis not detected. Sex as a biological variable We identified attention to sex/gender in the trial design phase by searching the study protocol registration fields – title, brief summary, detailed description, eligibility criteria descriptions and (primary, secondary, other) outcome measures – for the following terms (and their plurals): sex, gender, woman, female, man, male, girl, boy, pregnan*, HRT, hormone replacement therapy, estrogen, progesterone, testosterone and transg*. Table 2: Resources
Software and Algorithms Sentences Resources We … SciScore for 10.1101/2020.09.13.20193680: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization We only analyzed original publications of randomized controlled trials. Blinding not detected. Power Analysis not detected. Sex as a biological variable We identified attention to sex/gender in the trial design phase by searching the study protocol registration fields – title, brief summary, detailed description, eligibility criteria descriptions and (primary, secondary, other) outcome measures – for the following terms (and their plurals): sex, gender, woman, female, man, male, girl, boy, pregnan*, HRT, hormone replacement therapy, estrogen, progesterone, testosterone and transg*. Table 2: Resources
Software and Algorithms Sentences Resources We searched the PubMed database on June 2, 2020 for publications on SARS-CoV2/COVID-19 trials using the following search terms: "covid-19"[tw] AND trial[ti]. PubMedsuggested: (PubMed, RRID:SCR_004846)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
About SciScore
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