Title: Data Safety Monitoring and Collateral Benefits in Decentralized Trials.
Authors: Barnbaum, Deborah R.
Abstract: The article focuses on how collateral benefits should be considered differently by Institutional Review Boards (IRBs) and Data Safety Monitoring Boards (DSMBs) in decentralized clinical trials (DCTs). Topics include the ethical implications of incorporating collateral benefits during ongoing trials, the risk of overvaluing these benefits in the face of emerging direct harms, and the distinct responsibilities of IRBs versus DSMBs in risk-benefit assessments.
Subjects: DATA security; VASCULAR endothelial growth factors; CLINICAL trials; DIABETIC retinopathy; MACULAR edema; MEDICAL research; ETHICS committees; VISUAL acuity
Publication: American Journal of Bioethics, 2025, Vol 25, Issue 5, p101
ISSN: 1526-5161
Publication type: Academic Journal
DOI: 10.1080/15265161.2025.2488265

Data Safety Monitoring and Collateral Benefits in Decentralized Trials.

Barnbaum, Deborah R.