About: Assessing the Impact of COVID-19 on the Objective and Analysis of Oncology Clinical Trials -- Application of the Estimand Framework

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Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Assessing the Impact of COVID-19 on the Objective and Analysis of Oncology Clinical Trials -- Application of the Estimand Framework
Creator	Liu, Yi Liu, Feng Tang, Rui Casey, Michelle Degtyarev, Evgeny Englert, Stefan Rufibach, Kaspar Sailer, Oliver Shentu, Yue Siegel, Jonathan Sun, Steven Yung, Godwin Zhou, Jiangxiu
Source	ArXiv
abstract	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 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 intercurrent events, 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.
has issue date	2020-06-08(xsd:dateTime)
has license	arxiv
sha1sum (hex)	002fa40456380ed597f51cffdef15d934c445732
resource representing a document's title	Assessing the Impact of COVID-19 on the Objective and Analysis of Oncology Clinical Trials -- Application of the Estimand Framework
resource representing a document's body	covid:002fa40456380ed597f51cffdef15d934c445732#body_text
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