Real‐World Evidence and the Regulation of Medicines

Honig, Peter K.

doi:10.1002/cpt.2230

Cited by 8 publications

(7 citation statements)

References 11 publications

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“…One of the innovations resulting from the COVID-19 pandemic is the wider use and also regulatory acceptance of real-world data and pharmacovigilance reports [22]. On 8 May 2021, EUDRAvigilance reported sex-disaggregated data on the safety of approved COVID-19 vaccines.…”

Section: Discussionmentioning

confidence: 99%

Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis

et al. 2021

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Sex differences in adaptive and innate immune responses have been shown to occur and anecdotal reports suggest that vaccine efficacy and safety may be sex-dependent. We investigated the influence of sex on the efficacy of COVID-19 vaccines through a systematic review and meta-analysis of clinical trials on COVID-19 vaccines. The safety profile of COVID-19 vaccines was also investigated. A systematic review included eligible articles published in three databases and three websites. A meta-analysis of available data, stratified by sex, was conducted. Statistical analysis was performed using the Hartung–Knapp–Sidik–Jonkman method, as well as influence and heterogeneity analysis. Pooled analysis showed significantly higher efficacy, measured as the rate of new COVID-19 cases, in men compared to women in the vaccine group (OR = 0.67, 95% CI 0.48–0.94). No sex differences were found in the rate of new cases in the control group (OR = 0.92, 95% CI 0.78–1.09). Safety profiles derived from pharmacovigilance reports appear to indicate increased toxicity in women. In conclusion, evidence of a potential role of sex in COVID-19 vaccine efficacy was described. It strengthens the need to include sex as a core variable in the clinical trial design of COVID-19 vaccines.

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Section: Discussionmentioning

confidence: 99%

Sex Disparities in Efficacy in COVID-19 Vaccines: A Systematic Review and Meta-Analysis

et al. 2021

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“…RWE can be leverage to bring new medications to market, evaluate the safety and effectiveness of existing medications for new uses, and assess the continued performance and safety of products once on the market, across the drug total life cycle (Leveraging Real World Evidence in Regulatory Submissions of Medical Devices, 2021). The FDA, Health Canada and the European Medicines Agency are starting to rely on RWE to support their regulatory decisions to help speed patient access to innovations that advance public health (Honig, 2021). It is however essential to distinguish between the sources of RWD and the evidence derived from that data.…”

Section: Real-world Evidence For Decision Makingmentioning

confidence: 99%

Pharmacoepidemiology Research-Real-World Evidence for Decision Making

Bérard

2021

Front. Pharmacol.

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“…The advantage of this format is that it gives the journal more flexibility to respond to emerging topics in an agile and timely manner. We published 4 such mini‐themes in 2021 9–12 ( Table 1 ) and are planning to build on their success and positive reception by our readers and authors in the coming years.…”

Section: Figurementioning

confidence: 99%