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Data monitoring committees

Focus Area: Training

Data monitoring committees

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

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 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
Slide 01

DMC Training in Shanghai, China

MRCT Center, Merck, and Amgen partner to bring DMC training to China, hosted by DIA China in May 2014.

Slide 02

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.

Slide 03

DMC Training in Tokyo, Japan

MRCT Center, Lilly and JPMA collaborate to bring DMC training to Japan, in April 2014.

Slide 03

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.

Slide 03

DMC Training in Bangkok, Thailand

The MRCT Center co-hosted the DMC training in conjunction with the HIV-NAT, in January 2015.

Slide 03

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.

Slide 03

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

  • 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

DateLocationPartnerNo. Trained
May 2013Boston, USSociety of Clinical Trials30
Oct 2013Daegu, KoreaDaegu Catholic University Medical Center70
Jan 2014Bangalore, IndiaISCR50
April 2014Tokyo, JapanJPMA150
May 2014Shanghai, ChinaDIA20
Jan 2015Bangkok, ThailandHIV-NAT62
Oct 2015Beijing, ChinaPeking U.30
Nov 2015Johannesburg &
Cape Town, South Africa
Univ. of Witwatersrand & Univ. of Cape Town
Global Health Network
100
April 2016Sao Paolo, BrazilSociedade Brasileira de
Medicina Farmacêutica, Lilly
40
Sept 2016New Haven, USAYale, Novartis, CFDA30

Project Lead: Barbara Bierer