Update from the Multi-Regional Clinical Trials (MRCT) Center at Harvard
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*Steven Snapinn, Amgen 

Keywords: DSMB, Developing World, Clinical Trials

The mission of the MRCT Center at Harvard is to to improve the design, conduct, and oversight of multi-regional clinical trials, especially trials sited in or involving the developing world; to simplify research through the use of best practices; and to foster respect for research participants, efficacy, safety and fairness in transnational, trans-cultural human subjects research. One of the key focus areas of the center involves Data and Safety Monitoring Boards. The goal of this focus area is to build the capacity of DSMBs, especially those for multi-regional trials that involve the developing world, so that they can effectively monitor the safety and efficacy of clinical trials. A group of DSMB experts is drafting a role-based, best practices document. The work group also develops and offers regional DSMB trainings to build intellectual infrastructure in places such as India, Korea, and Japan. In this presentation I’ll give an update of this group’s activities.