File(s) under permanent embargo
Building a More Connected DSMB: Better Integrating Ethics Review and Safety Monitoring
Data and Safety Monitoring Boards (DSMBs) have become an increasingly common feature of clinical trial oversight, yet a paucity of legal or ethical frameworks govern these Boards’ composition or operation, or their relationship with other actors with monitoring responsibilities. This paper argues that prevailing structural gaps are impeding harmonized systems for monitoring the ongoing ethical acceptability of 10 clinical trials. Particular tensions stem from DSMBs’ sweeping discretion in deciding whether and when to recommend that a trial should be terminated or amended based on safety and efficacy information. This discretion becomes especially challenging in light of DSMBs’ monopoly over emerging trial data, which prevents Institutional Review Boards, sponsors, and investigators from participating in certain pivotal and ethically 15 charged decisions. To address these disconnects, I advocate for strengthened pre-trial and post-trial communication in addition to innovative strategies to support DSMB decision making through the life of a trial.
History
Publication title
Accountability in Research: policies and quality assuranceVolume
22Pagination
81-105ISSN
0898-9621Department/School
Faculty of LawPublisher
Taylor & Francis Inc.Place of publication
United StatesRights statement
Copyright 2014 Taylor and FrancisRepository Status
- Restricted