試験プロトコルと完了した試験の報告に関するガイドラインは,COVID-19のパンデミックおよびその他の緩和的な状況により変更されました.CONSERVE 2021の声明
Aaron M Orkin1,2, Peter J Gill3, Davina Ghersi4
1Division of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.
JAMA
|June 21, 2021
まとめ
COVID-19のような緩和的な状況により,ランダム化試験は変化することがあります. CONSERVEガイドラインは,より透明性と有効性のために,これらの重要な試験変更の報告を改善します.
科学分野:
- 臨床試験の方法論
- 研究倫理
- 科学的報告基準
背景:
- 緩和的な状況 (例えば,COVID-19) に起因するランダム化試験の計画外変更は,重要な方法論的,倫理的,分析的な課題を提示する.
- 既存の報告ガイドラインは,これらの重要な試験改変を文書化するための不完全なガイドラインを提供しており,研究有効性を損なう可能性があります.
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