Data monitoring committees
Focus Area: Capacity Building
Countries in which global clinical trials are conducted are often underrepresented in the Data Monitoring Committees (DMCs) that oversee these trials. Recognizing the need for greater engagement from emerging economies, the MRCT Center created a training program in 2012 aiming to engage motivated individuals to become DMC champions within their home country and to participate in DMCs for multi-regional clinical trials.
Current Status: Implementation and Dissemination
Impact: Increased engagement of experts from emerging countries on Data Monitoring Committees
Objectives
The objectives of the DMC initiative are to identify, recruit and train leaders from emerging economies who have expertise in clinical trials, medicine, or statistics and who would like to serve on DMCs (also termed Data Safety Monitoring Boards [DSMBs].)
Through training and resources we aim to:
- develop best practices for DMCs
- educate and train DMC members for trials sited in emerging economies
- qualify new DMC members from emerging regions
- develop infrastructure for DMCs in the developing world for locally-sponsored trials
Deliverables
DMC Training in Shanghai, China
MRCT Center, Merck, and Amgen partner to bring DMC training to China, hosted by DIA China in May 2014.
DMC Training in Bangalore, India
MRCT Center, Amgen, and Indian Society of Clinical Research (ISCR) partner on DMC training in Bangalore, India, in conjunction with the ISCR annual meeting in January 2014.
DMC Training in Tokyo, Japan
MRCT Center, Lilly, and JPMA collaborate to bring DMC training to Japan, in April 2014.
DMC Training in Daegu, South Korea
MRCT Center and Daegu Catholic University Medical Center partnered to bring DMC training to South Korea, in October 2013.
DMC Training in Bangkok, Thailand
The MRCT Center co-hosted the DMC training in conjunction with the HIV-NAT, in January 2015.
DMC Training in Johannesburg, South Africa
MRCT Center and the University of Witwatersrand collaborate on one day session in Johannesburg, South Africa, in November 2015.
DMC Training in Cape Town, South Africa
MRCT Center and the Global Health Network partner for one day session in Cape Town, South Africa, November 2015.
Key Milestones
- 2016: Published article “Responsibilities of Data Monitoring Committees: Consensus Recommendations” in Therapeutic Innovation & Regulatory Science
- 2015: Trained in Bangkok, Thailand, and in Johannesburg and Cape Town, South Africa
- 2014: Focused on Asia with regional trainings held in China, India and Japan
- 2013: Trained our inaugural class of 11 highly experienced investigators representing Argentina, Brazil, India, Korea, Mexico, Russia, South Africa, Tanzania, and Thailand and other
Project Leadership:
Barbara Bierer, MD. MRCT Center Faculty Director