A Qualitative Scoping Review of Early-Terminated Clinical Trials Sponsored by the Department of Veterans Affairs Cooperative Studies Program From 2010 to 2020

Abstract

Increasing attention has been paid to the risks and benefits of terminating large clinical trials before reaching prespecified targets, because such decisions can greatly affect the implementation of findings. The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) is a research infrastructure dedicated to conducting high-quality clinical research. A scoping review was performed to characterize barriers preventing the attainment of prespecified recruitment, statistical power, or sample-size targets in VA CSP trials. A trial was eligible for inclusion if the trial was sponsored by the VA CSP, primary findings were published within the last 10 years, and a decision was made to terminate enrollment or follow-up before meeting a priori recruitment or endpoint targets. In 11 of 29 included trials (37.9%), a decision was made to terminate the trial early. The most common reason for early termination was related to under-recruitment (n = 5). Other reasons included early detection of safety signals (n = 2), futility (n = 1), and benefit (n = 1). This review highlights recruitment as a critical facet of trial conduct that may hinder the production of high-quality data and thus warrant additional attention. Solutions to enhance recruitment now implemented by the VA CSP, including dedicated enrollment infrastructure and screening facilitated by informatics approaches, show promise in reducing this cause for early termination.

Keywords: clinical trials; review; scoping review.

Figure 1

Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram for the process of identifying the clinical trials involving the Department of Veterans Affairs Cooperative Studies Program (CSP) that were terminated early. The identification process yielded a total of 108 publications. Screening based on title and abstract excluded 36 publications, with an additional 18 publications were excluded for not meeting the criteria for this scoping review. A total of 29 publications were eligible, with 11 of those reviewed in detail for early-termination justification. HMIC, Healthcare Management Information Consortium.