The D2d DSMB inaugural meeting takes place
The inaugural meeting of the D2d Data Safety Monitoring Board (DSMB) takes place in Bethesda, MD. The core D2d team – composed of Dr. Pittas (principal investigator), Dr. Staten (NIH project scientist), Dr. Ware (lead statistician) and Ms. Sheehan (project manager) – present the rationale of D2d and the study protocol. The DSMB recommends clarifications to the protocol and approves the study protocol on July 15, 2013. In its official letter to the funding agency (NIDDK) and the D2d team, the DSMB warns multiple times that the board will continue to examine throughout the study the need for early termination of the study due to futility.