دورية أكاديمية

Rethinking remdesivir for COVID-19: A Bayesian reanalysis of trial findings.

التفاصيل البيبلوغرافية
العنوان: Rethinking remdesivir for COVID-19: A Bayesian reanalysis of trial findings.
المؤلفون: Hoek JM; Behavioural and Social Sciences, University of Groningen, Groningen, The Netherlands., Field SM; Behavioural and Social Sciences, University of Groningen, Groningen, The Netherlands., de Vries YA; Behavioural and Social Sciences, University of Groningen, Groningen, The Netherlands., Linde M; Behavioural and Social Sciences, University of Groningen, Groningen, The Netherlands., Pittelkow MM; Behavioural and Social Sciences, University of Groningen, Groningen, The Netherlands., Muradchanian J; Behavioural and Social Sciences, University of Groningen, Groningen, The Netherlands., van Ravenzwaaij D; Behavioural and Social Sciences, University of Groningen, Groningen, The Netherlands.
المصدر: PloS one [PLoS One] 2021 Jul 23; Vol. 16 (7), pp. e0255093. Date of Electronic Publication: 2021 Jul 23 (Print Publication: 2021).
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
أسماء مطبوعة: Original Publication: San Francisco, CA : Public Library of Science
مواضيع طبية MeSH: SARS-CoV-2* , COVID-19 Drug Treatment*, Adenosine Monophosphate/*analogs & derivatives , Alanine/*analogs & derivatives , COVID-19/*epidemiology, Adenosine Monophosphate/administration & dosage ; Alanine/administration & dosage ; Clinical Trials as Topic ; Europe/epidemiology ; Humans ; Treatment Outcome ; United States/epidemiology
مستخلص: Background: Following testing in clinical trials, the use of remdesivir for treatment of COVID-19 has been authorized for use in parts of the world, including the USA and Europe. Early authorizations were largely based on results from two clinical trials. A third study published by Wang et al. was underpowered and deemed inconclusive. Although regulators have shown an interest in interpreting the Wang et al. study, under a frequentist framework it is difficult to determine if the non-significant finding was caused by a lack of power or by the absence of an effect. Bayesian hypothesis testing does allow for quantification of evidence in favor of the absence of an effect.
Findings: Results of our Bayesian reanalysis of the three trials show ambiguous evidence for the primary outcome of clinical improvement and moderate evidence against the secondary outcome of decreased mortality rate. Additional analyses of three studies published after initial marketing approval support these findings.
Conclusions: We recommend that regulatory bodies take all available evidence into account for endorsement decisions. A Bayesian approach can be beneficial, in particular in case of statistically non-significant results. This is especially pressing when limited clinical efficacy data is available.
Competing Interests: The authors have declared that no competing interests exist.
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المشرفين على المادة: 3QKI37EEHE (remdesivir)
415SHH325A (Adenosine Monophosphate)
OF5P57N2ZX (Alanine)
تواريخ الأحداث: Date Created: 20210723 Date Completed: 20210802 Latest Revision: 20221207
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC8301659
DOI: 10.1371/journal.pone.0255093
PMID: 34297766
قاعدة البيانات: MEDLINE
الوصف
تدمد:1932-6203
DOI:10.1371/journal.pone.0255093