Abstract–The COVID-19 pandemic has a global impact on the conduct of clinical trials of medical products. This article discusses implications of the COVID-19 pandemic on clinical research methodology aspects and provides points to consider to assess and mitigate the risk of seriously compromising the integrity and interpretability of clinical trials. The information in this article will support discussions that need to occur cross-functionally on an ongoing basis to “integrate all available knowledge from the ethical, the medical, and the methodological perspective into decision making.” This article aims at facilitating: (i) risk assessments of the impact of the pandemic on trial integrity and interpretability; (ii) identification of the relevant data and information related to the impact of the pandemic on the trial that needs to be collected; (iii) short-term decision making impacting ongoing trial operations; (iv) ongoing monitoring of the trial conduct until completion, including the possible involvement of data monitoring committees, and adequately documenting all measures taken to secure trial integrity throughout and after the pandemic, and (v) proper analysis and interpretation of the eventual interim or final trial data.

摘要-COVID-19大流行对医疗产品的临床试验进行了全球性影响。本文讨论了COVID-19大流行对临床研究方法论方面的影响，并提供了一些要点来评估和减轻严重损害临床试验的完整性和可解释性的风险。本文中的信息将为需要不断进行跨职能的讨论提供支持，以“将来自道德，医学和方法学的所有可用知识整合到决策中”。本文旨在促进：（i）大流行对审判完整性和可解释性影响的风险评估；（ii）确定需要收集的与大流行对试验的影响有关的相关数据和信息；（iii）影响正在进行的审判活动的短期决策；（iv）持续监视审判行为直至完成，包括可能由数据监视委员会参与，并充分记录为确保整个大流行期间和之后的审判完整性而采取的所有措施，以及（v）对最终的临时措施进行适当的分析和解释或最终审判数据。