The role of data and safety monitoring boards in implementation trials: When are they justified?
Year: 2020
Type: article
Abstract: The National Institutes of Health requires data and safety monitoring boards (DSMBs) for all phase III clinical trials. The National Heart, Lung and Blood Institute requires DSMBs for all clinical trials involving more than one site and those involving cooperative agreements and contracts. These policies have resulted in the establishment of DSMBs for many implementation trials, with little consideration regarding the appropriateness of DSMBs and/or key adaptations needed by DSMBs to monitor data quality and participant safety. In this perspective, we review the unique features of implementation trials and reflect on key questions regarding the justification for DSMBs and their potential role and monitoring targets within implementation trials.
DOI: 10.1017/cts.2020.19
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,750
Awards: Transforming Translational Science and Education to Benefit Human Health, N2: BUILDING A NETWORK OF SAFETY NET PBRNS, Implementation Research: Translating the ABC's into HIV Care, G674291738, Blood Pressure-Visit Intensification for Successful Improvement of Treatment, The University of Rochester Clinical and Translational Science Award Hub, G8034983374
OpenAlex ID: W3009504018