Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies.

ABSTRACT: Pragmatic randomized clinical trials (pRCTs) have a unique set of considerations for data and safety monitoring. Because of their unconventional trial designs coupled with collection of multilevel data and implementation outcomes in real-world settings, thoughtful consideration is needed on the presentation of the trial design and accruing data to facilitate review and decision-making by the trial's data and safety monitoring board (DSMB). To our knowledge, there is limited information available in practical guidelines for generalists and medical general practitioners on what to monitor and to report to the DSMB during the conduct of pRCTs and what the DSMB should focus on in its review of reports. This article discusses these matters in the context of 3 case studies focusing on a set of c

SUBMITTER: Zahrieh D 

PROVIDER: S-EPMC10807861 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature