Data monitoring committees
Focus Area: Training
Countries in which global clinical trials are conducted are often underrepresented in the Data Monitoring Committees (DMCs) that oversee safety for these trials. Recognizing the need for more engagement from emerging economies, the MRCT Center created a training program in 2012 with the aim to transform motivated individuals into DMC champions within their home country and participate in DMCs for multi-regional clinical trials.
Current Status: ongoing trainings
Increased engagement of experts from emerging countries on Data Monitoring Committees
The objectives of the DMC initiative are to identify, recruit and train leaders from emerging regions who have expertise in medicine or statistics, experience in clinical trials, and who would like to serve on DMCs, also termed Data Safety Monitoring Boards (DSMBs).
Through the development of training programs and resources we aim to ultimately:
- increase protection of study participants
- develop best practices for DMCs
- educate and train DMC members for trials sited in the developing world
- qualify new DMC members from emerging markets
- develop infrastructure for DMCs in the developing world for locally-sponsored trials
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 ISCR partner on DMC training in Bangalore 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 Watersrand 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.
- 2013 — Trained our inaugural class of 11 highly experienced investigators representing Argentina, Brazil, India, Korea, Mexico, Russia, South Africa, Tanzania, and Thailand.
- 2014 — Focus has been in Asia with regional trainings held in China, India and Japan and over 120 total participants trained.
- 2015 — Training in Bangkok and in Johannesburg and Cape Town with over 130 total participants trained
- 2016 — Article “Responsibilities of Data Monitoring Committees: Consensus Recommendations” published in Therapeutic Innovation & Regulatory Science
DMC Training Sessions
|May 2013||Boston, US||Society of Clinical Trials||30|
|Oct 2013||Daegu, Korea||Daegu Catholic University Medical Center||70|
|Jan 2014||Bangalore, India||ISCR||50|
|April 2014||Tokyo, Japan||JPMA||150|
|May 2014||Shanghai, China||DIA||20|
|Jan 2015||Bangkok, Thailand||HIV-NAT||62|
|Oct 2015||Beijing, China||Peking U.||30|
|Nov 2015||Johannesburg & |
Cape Town, South Africa
|Univ. of Witwatersrand & Univ. of Cape Town|
Global Health Network
|April 2016||Sao Paolo, Brazil||Sociedade Brasileira de|
Medicina Farmacêutica, Lilly
|Sept 2016||New Haven, USA||Yale, Novartis, CFDA||30|
Project Lead: Barbara Bierer