Focus Area: Capacity Building

The Multi-Regional Clinical Trial Center at Harvard has an initiative focused on training of Data Safety Monitoring Board (DSMB) members; this initiative is driven by a working group comprised of stakeholders from industry and academia and the 2013 class of DSMB Fellows were equally as diverse.

The goal of the initiative is to identify, train, recruit experts from emerging regions who have expertise in medicine or statistics, experience in clinical trials, and who would like to serve on Data Safety Monitoring Boards or Committees. The mission is to increase engagement of experts from emerging world countries on DSMBs, since currently, the countries in which many clinical trials are run are not represented in these important committees.

The culmination of this work has been the selection of the first class of fellows for this training. The fellows attended the workshop training, co-sponsored by the Society of Clinical Trials. They attended two pre-meeting workshops (P3 and P9) on May 19, 2013 titled “So you’ve said “yes” Now What? Sitting on or Chairing a Data Safety Monitoring Board” and “Data Safety Monitoring Boards for Multi-Regional Clinical Trials.”

Out of 90 applications, 11 fellows were selected from Brazil, India, Korea, Mexico, South Africa, Thailand, Argentina, and Russia. The Society for Clinical Trials met next in Boston, Massachusetts, May 19-22, 2013. For information about the Society and the meeting, see www.sctweb.org.

The Society for Clinical Trials, created in 1978, is an international professional organization dedicated to the development and dissemination of knowledge about the design, conduct and analysis of government and industry-sponsored clinical trials and related health care research methodologies.

The Data & Safety Monitoring Work Group is holding an all-day training session for eleven fellows on May 19, 2013.

The eleven fellows are traveling to Boston for the training and the SCT 34th Annual Meeting. They will be coming from Brazil, South Korea, India, South Africa, Thailand, Russia and Mexico. Fellows were selected from countries that commonly host clinical trials, but which are often not represented on the trials’ Data and Safety Monitoring Boards. They were chosen based on previous experience with clinical trials and their intention to contribute to clinical trial research in the future.

On February 15, 2013, the MRCT PI Training and Competence Working Group hosted a half-day focus group collaboration meeting at the Harvard Global Health Institute with Ingrid Klingmann (IMI/Pharmatrain), Bob O’Neill (FDA), Greg Koski (ACRES), Honorio Silva (ACRES) and Jason Nyrop (Deloitte) and Rohin Rajan (Deloitte). The objectives of the meeting included:

• Discuss in-flight, planned initiatives and strategic approaches in PI training and standards
• Discuss how the groups might collaborate towards a single set of standards for PI competency
• Lay out a roadmap in this area for our groups to avoid duplication of efforts, maximize efficiencies and promote collaboration