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Today, CTTI unveiled new recommendations on best practices for the use of Data Monitoring Committees (DMCs), an important approach to ensure the validity and integrity of a clinical trial when there is a need to periodically review accumulating safety and efficacy data and advise on whether to continue, modify, or terminate a trial based on the benefit-risk assessment.
 
CTTI recommendations are intended to enhance the functioning of a DMC, beginning with training of members. Other issues addressed by CTTI include the role and responsibilities of the DMC, composition of members, development of a charter, and communication with the trial sponsor and others. The recommendations were presented during a session at the Society of Clinical Trials (SCT) annual meeting. Dr. David DeMets, a thought leader on DMCs, chaired a session that also included project team members Karim Calis of FDA, Raymond Bain of Merck Research Laboratories, and Annemarie Forrest of CTTI.
 
As noted by Dr. Calis, “DMCs play a unique and critical role in trial oversight. The clinical trial enterprise—including investigators, sponsors, trial participants, and other stakeholders—benefits greatly from having strong, independent DMCs that have adequate resources and sufficient flexibility to carry out their important mission.”
 
The full recommendations are available on the CTTI website and will also be presented in a CTTI-hosted free, public webinar on June 16, 2016 from 12:00 - 1:00 PM EST (New York, GMT-04:00). See below for additional details on this upcoming webinar:
 
Speakers:


  • Dave DeMets, PhD, Professor and Chair of the Department of Biostatistics and Medical Informatics, University of Wisconsin - Madison

  • Jane Perlmutter, PhD, Patient Advocate

  • Karim Calis, PharmD, MPH, FASHP, FCCP, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

  • Meeting Link: Click here to join WebEx meeting on June 16

  • Meeting number: 732 840 380

  • Meeting password: DMCctti


 
Or join by phone only:

  • 1-855-244-8681 Call-in toll-free number (US/Canada)

  • 1-650-479-3207 Call-in toll number (US/Canada)

  • Access code: 732 840 380