Assessment of North American Clinical Research Site Performance During the Start-up of Large Cardiovascular Clinical Trials.

ABSTRACT:

Importance

Randomized clinical trials (RCTs) are critical in advancing patient care, yet conducting such large-scale trials requires tremendous resources and coordination. Clinical site start-up performance metrics can provide insight into opportunities for improved trial efficiency but have not been well described.

Objective

To measure the start-up time needed to reach prespecified milestones across sites in large cardiovascular RCTs in North America and to evaluate how these metrics vary by time and type of regulatory review process.

Design, setting, and participants

This cohort study evaluated cardiovascular RCTs conducted from July 13, 2004, to February 1, 2017. The RCTs were coordinated by a single academic research organization, the Duke Clinical Research Instit

SUBMITTER: Goyal A 

PROVIDER: S-EPMC9435961 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature