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Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic.
Meyer, R Daniel; Ratitch, Bohdana; Wolbers, Marcel; Marchenko, Olga; Quan, Hui; Li, Daniel; Fletcher, Christine; Li, Xin; Wright, David; Shentu, Yue; Englert, Stefan; Shen, Wei; Dey, Jyotirmoy; Liu, Thomas; Zhou, Ming; Bohidar, Norman; Zhao, Peng-Liang; Hale, Michael.
  • Meyer RD; Pfizer Inc., Groton, CT.
  • Ratitch B; Bayer, Montreal, QC, Canada.
  • Wolbers M; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Marchenko O; Bayer, Whippany, NJ.
  • Quan H; Sanofi, Bridgewater, NJ.
  • Li D; Bristol Myers Squibb, Princeton, NJ.
  • Fletcher C; GlaxoSmithKline, Stevenage, Hertfordshire, UK.
  • Li X; Genentech/Roche, South San Francisco, CA.
  • Wright D; AstraZeneca, Cambridge, Cambridgeshire, UK.
  • Shentu Y; Merck & Co., Inc., Rahway, NJ.
  • Englert S; Abbvie Deutschland GmbH & Co KG, Ludwigshafen, Germany.
  • Shen W; Eli Lilly and Company, Indianapolis, IN.
  • Dey J; Abbvie Inc., North Chicago, IL.
  • Liu T; Amgen Inc., Thousand Oaks, CA.
  • Zhou M; Bristol Myers Squibb, Princeton, NJ.
  • Bohidar N; Johnson&Johnson, Spring House, PA.
  • Zhao PL; Sanofi, Bridgewater, NJ.
  • Hale M; Takeda, Cambridge, MA.
Stat Biopharm Res ; 12(4): 399-411, 2020 Jul 06.
Article in English | MEDLINE | ID: covidwho-574529
ABSTRACT
Abstract-The COVID-19 pandemic has had and continues to have major impacts on planned and ongoing clinical trials. Its effects on trial data create multiple potential statistical issues. The scale of impact is unprecedented, but when viewed individually, many of the issues are well defined and feasible to address. A number of strategies and recommendations are put forward to assess and address issues related to estimands, missing data, validity and modifications of statistical analysis methods, need for additional analyses, ability to meet objectives and overall trial interpretability.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study / Randomized controlled trials Language: English Journal: Stat Biopharm Res Year: 2020 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study / Randomized controlled trials Language: English Journal: Stat Biopharm Res Year: 2020 Document Type: Article