Published in:National Center for Biotechnology Information, NIH
Description: The authors address the lack of access to the charters of data monitoring committees (DMCs) and call on the NIH to allow their voluntary upload into ClinicalTrials.gov.
DeMets DL, Zarin DA, Rockhold F, Ellenberg SS, Fleming T, Wittes J. Bringing data monitoring committee charters into the sunlight. Clin Trials. 2023 May 25:17407745231169499. doi: 10.1177/17407745231169499. Epub ahead of print. PMID: 37231737.
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Description: As data sharing is expanded in the context of greater community engagement in research, we must ask to whom do benefits of data sharing accrue and to whom do benefits not accrue? In an era of growing efforts to engage diverse communities in research, the impact of data sharing for all research participants and the communities that they represent requires the reassessment of the principles of data sharing, incorporating principles of community-engaged research. This article outlines these considerations and proposes new models of benefit sharing.
Trial termination (the decision to end a trial earlier than planned) has been reported in 17.9% of cardiovascular trials and 16.0% of surgical trials.1,2 Although some trials are terminated for scientific reasons due to safety, efficacy, or futility, many trials are terminated due to inadequate participant enrollment or other nonscientific reasons.
