title: Enhancing trial integrity by protecting the independence of data monitoring committees in clinical trials.
abstract: Data monitoring committees (DMCs) have important roles in safeguarding patient interests and enhancing trial integrity and credibility. To effectively fulfill their responsibilities, DMCs should be independent of study sponsors, study investigators, and caregivers managing study participants. Unfortunately, in real-world settings where DMCs are in place, there are some practices that threaten to diminish the level of independence of these committees. To address this, some important approaches should be considered: A DMC charter should outline the roles and responsibilities of the DMC without appearing to be a legal contract; the meetings of the DMC should be led by its chair, ideally with a meeting format that ensures independence from the investigators and sponsor; the DMC and those having leadership roles in the monitoring process should have adequate training and experience; procedures should be in place to enable the DMC to have access to interim safety and efficacy data that are accurate, current, and comprehensive; these data should be presented to the DMC unblinded by treatment group, while being kept confidential from all others; DMC recommendations should be developed through consensus development rather than by casting votes; creative approaches are needed for the engagement of DMC members to increase the transparency such that they are neither employees of nor consultants to the sponsor of the trial; meaningful conflicts of interest should be identified and addressed; and finally, members of DMCs should have adequate indemnification that provides effective protection.
authors.affiliation: a Department of Biostatistics , University of Washington , Seattle , Washington , USA.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Fleming
authors.forename: Charles H
authors.initials: CH
authors.lastname: Hennekens
authors.forename: Marc A
authors.initials: MA
authors.lastname: Pfeffer
authors.forename: David L
authors.initials: DL
authors.lastname: DeMets
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000331:legislation & jurisprudence / Q000458:organization & administration; D003219:Confidentiality; D016265:Conflict of Interest; D003627:Data Interpretation, Statistical; D003657:Decision Making; D017009:Professional Autonomy; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data
keywords: Confidentiality; Conflict of interest; DMC charter; Indemnification