Estimators for handling COVID-19-related intercurrent events with a hypothetical strategy.

ABSTRACT: The COVID-19 pandemic has affected clinical trials across disease areas, raising the questions how interpretable results can be obtained from impacted studies. Applying the estimands framework, analyses may seek to estimate the treatment effect in the hypothetical absence of such impact. However, no established estimators exist. This simulation study, based on an ongoing clinical trial in patients with Tourette syndrome, compares the performance of candidate estimators for estimands including either a continuous or binary variable and applying a hypothetical strategy for COVID-19-related intercurrent events (IE). The performance is investigated in a wide range of scenarios, under the null and the alternative hypotheses, including different modeling assumptions for the effect of the IE and

SUBMITTER: Lasch F 

PROVIDER: S-EPMC9349873 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature