The Clinical Trials Transformation Initiative (CTTI) invites you to participate in a webinar to learn about its new recommendations on best practices for the use of Data Monitoring Committees (DMCs), 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.  CTTI’s recommendations can help 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.

• Topic:  DMC Project Recommendations
• Date:   Thursday, June 16, 2016
• Time:  12:00 p.m. – 1:00 p.m. EST (New York, GMT-05:00)
• Presenters:
  • Karim Anton Calis, PharmD, MPH, FASHP, FCCP, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • Jane Perlmutter, PhD, Patient Advocate
  • Dave DeMets, PhD, Professor, Department of Biostatistics and Medical Informatics, University of Wisconsin – Madison

This webinar is open to the public.  We encourage you to share this invitation with others who may be interested in learning more about CTTI’s DMCs Project Recommendations.

To join:

Meeting Link: Join WebEx meeting
Meeting Number:  732 840 380
Meeting Password: DMCctti
After you connect to the website, please follow step-by-step instructions for connecting to the audio.

If you prefer to connect to audio only, you can join by phone at:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)