Responsibilities of Data Monitoring Committees: Consensus Recommendations

Conclusions:
The group recommended practices for each phase of the DMC process from inception through execution of a clinical trial, with appropriate considerations for confidentiality. The group’s practical guidance should assist in comprehensive oversight of appropriate clinical trials and should help DMC members execute their obligations with greater assurance.

Source: Therapeutic Innovation and Regulatory Science - August 25, 2016 Category: Drugs & Pharmacology Authors: Bierer, B. E., Li, R., Seltzer, J., Sleeper, L. A., Frank, E., Knirsch, C., Aldinger, C. E., Levine, R. J., Massaro, J., Shah, A., Barnes, M., Snapinn, S., Wittes, J. Tags: Clinical Trials Source Type: research