The industry has seen a recent increase in the usage of Data Monitoring Committees (aka Data Safety Monitoring Boards) to gain independent assessment of interim trial safety, efficacy and integrity. DMCs offer an opportunity for a team of experts, independent from the trial sponsor, to examine the interim clinical data and make unbiased recommendations for the continuation, alteration and termination of the trial. Incorporating DMCs into trial design and conduct adds additional protection against proceeding with an unsafe product or futile trial design which mitigates risk to subjects, optimizes resource utilization for the sponsor by reassuring study integrity and protects the public from access to unsafe products.
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