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10.1080/19466315.2020.1785543

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34191975!8011489!34191975
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suck abstract from ncbi


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pmid34191975      Stat+Biopharm+Res 2020 ; 12 (4): 427-437
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  • Assessing the Impact of COVID-19 on the Clinical Trial Objective and Analysis of Oncology Clinical Trials-Application of the Estimand Framework #MMPMID34191975
  • Degtyarev E; Rufibach K; Shentu Y; Yung G; Casey M; Englert S; Liu F; Liu Y; Sailer O; Siegel J; Sun S; Tang R; Zhou J
  • Stat Biopharm Res 2020[Jul]; 12 (4): 427-437 PMID34191975show ga
  • Abstract-Coronavirus disease 2019 (COVID-19) outbreak has rapidly evolved into a global pandemic. The impact of COVID-19 on patient journeys in oncology represents a new risk to interpretation of trial results and its broad applicability for future clinical practice. We identify key intercurrent events (ICEs) that may occur due to COVID-19 in oncology clinical trials with a focus on time-to-event endpoints and discuss considerations pertaining to the other estimand attributes introduced in the ICH E9 addendum. We propose strategies to handle COVID-19 related ICEs, depending on their relationship with malignancy and treatment and the interpretability of data after them. We argue that the clinical trial objective from a world without COVID-19 pandemic remains valid. The estimand framework provides a common language to discuss the impact of COVID-19 in a structured and transparent manner. This demonstrates that the applicability of the framework may even go beyond what it was initially intended for.
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