Trial Governance - Committees

The Executive, Advisory and Manufacturers Operations Committees are intended to provide relevant expertise and guidance to HCRI and will meet independently throughout the DAPT Study. The size and scope of this study will require a wide range of scientific, clinical, and ethical expertise organized through the collaborative structure of the following committees.

Executive Committee

The executive committee for the DAPT Study is responsible for the ongoing scientific management of the study. The members of this committee and other international physicians have been key scientific advisors in the design of this trial. In addition to the principal investigators, Dr. Donald Cutlip, M.D., Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; Dr. Philippe Gabriel Steg of Centre Hospitalier Bichat-Claude Bernard and Université Paris VII; and Dr. Sharon-Lise Normand, Ph.D., of Harvard School of Public Health and Harvard Medical School, Cambridge, MA, comprise the Executive Committee for the Study.

Advisory Committee

The Advisory Committee for the DAPT Study will provide guidance to HCRI and the Executive Committee on matters related to Study progress and conduct as well as the scientific issues that may arise during the course of the Study. The members of this committee are experienced physicians and clinical trial managers from the global cardiology community. Chairman, Eugene Braunwald, M.D., Brigham and Women’s Hospital and Harvard Medical School

Manufacturers Operations Committee

The manufacturers supporting the Study are represented on a Manufacturers Operations Committee, in order to share expertise specific to their products, and to maintain oversight of funding.

Data Monitoring Committee

Patient safety in the DAPT Study will be monitored throughout the trial by an independent Data Monitoring Committee (DMC). The DMC is an independent group of physicians from the fields of cardiology and interventional cardiology and at least one biostatistician, who are not directly involved in the conduct of the DAPT Study. The DMC will review the study enrollment and subject safety (including reported serious adverse events) on a regular basis. Chairman, Robert Bonow, M.D., Northwestern Memorial Hospital