Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative.

ABSTRACT: Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and conduct. To understand and describe the role and function of data monitoring committees, and establish best practices for data monitoring committee trial oversight, the Clinical Trials Transformation Initiative-a public-private partnership to improve clinical trials-launched a multi-stakeholder project. Methods The data monitoring committee project team included 16 individuals charged with (1) clarifying

SUBMITTER: Calis KA 

PROVIDER: S-EPMC5639979 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature