Suspension of Oncology Randomized Clinical Trials during the COVID-19 Pandemic: A Cross-Sectional Evaluation of COVID-Related Suspensions

Abstract

We conducted a cross-sectional analysis of ClinicalTrials.gov-registered oncology randomized controlled trials between September 2019 and December 2021 to identify predictors of trial suspensions. The dataset included 1,183 oncology trials, of which 384 (32.5%) were suspended. COVID-19 accounted for 47 (12.2%) suspensions. Trials that were single center- or US-based had higher odds of COVID-19 (ORs: 3.85 and 2.48, 95% CIs: 1.60–11.50 and 1.28–4.93, respectively) or any-reason suspensions (ORs: 2.33 and 2.04, 95% CIs: 1.46–3.45 and 1.40–2.76, respectively). Phase two (OR 1.27), three (OR 6.45) and four trials (OR 11.5) had increased odds of COVID-19 suspensions, compared to phase one trials.

Keywords:

• Coronavirus
• oncology
• pandemic
• randomized controlled trial
• suspensions

Disclosure statement

No potential conflict of interest was reported by the author(s).

Author contributions

RKS: Conceptualization, data analysis and interpretation, manuscript drafting and approval, accountable for accuracy and integrity of work. AH: Study conception, data acquisition, manuscript critical revision and approval, accountable for accuracy and integrity of work. PW: Study conception, data acquisition, manuscript critical revision and approval, accountable for accuracy and integrity of work. MDO: Data interpretation, manuscript critical revision and approval, accountable for accuracy and integrity of work. JHL: Data interpretation, manuscript critical revision and approval, accountable for accuracy and integrity of work. MKT: Data interpretation, manuscript critical revision and approval, accountable for accuracy and integrity of work. CJDW: Study conception and design, data interpretation, manuscript critical revision and approval, accountable for accuracy and integrity of work. ZK: Study conception and design, data interpretation, manuscript critical revision and approval, accountable for accuracy and integrity of work.