Impact of COVID-19 pandemic on oncology clinical trial design, data collection and analysis.

ABSTRACT:

Background

To identify and assess via simulation the impact of COVID-19 pandemic on oncology trials and discuss potential mitigation strategies for study design, data collection, endpoints and analyses.

Methods

We simulated clinical trials to evaluate the COVID-19 impact on overall survival and progression-free survival. We evaluated survival in single-region trials with different proportions of impacted patients across treatment arms, and in multi-region randomized trials with different proportions of impacted patients across regions. We also assessed the impact on PFS when the missingness of disease assessment and censoring rules vary. Impact on the trial success and robustness of statistical inference was summarized.

Results

Without regional impact, the impact on O

SUBMITTER: Tang RS 

PROVIDER: S-EPMC8935956 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature