Data monitoring committees: Promoting best practices to address emerging challenges (original) (raw)
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Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative
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Clinical trials (London, England), 2017
The use of data monitoring committees in the conduct of clinical trials has increased and evolved, but there is a lack of published information on when data monitoring committees are needed and utilized, the acceptable range of data monitoring committee practices, and appropriate qualifications of data monitoring committee members. To gain a better understanding of data monitoring committee operations and areas for improvement, the Clinical Trials Transformation Initiative conducted a survey and set of focus groups. A total of 143 respondents completed the online survey: 76 data monitoring committee members, 52 sponsors involved with organization of data monitoring committees, and 15 statistical data analysis center representatives. There were 42 focus group participants, including data monitoring committee members; patients and/or patient advocate data monitoring committee members; institutional review board and US Food and Drug Administration representatives; industry, government,...
Data & Safety Monitoring Boards in Industry-Sponsored Clinical Trials
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The frequency of reported use of a Data & Safety Monitoring Board (DSMB) in industry- sponsored clinical trials and characteristics of trials involving a DSMB were investigated. Protocols and clinical trial agreements (CTAs) for 32 industry-sponsored trials (21 drug and 11 device) were reviewed. Based on the protocol review, 19 trials (59%) used a DSMB, while none of the reviewed