Data Monitoring Committees: Ensure Safety and Efficiency in Your Clinical Trial

Clinical trials, in particular large trials of long duration, are very expensive, highly complex, and of increasing importance to the development and registration of new drugs.  They have come to require independent monitoring in order to assure that the trial is conducted in a manner that is ethical and sufficient to protect patients and to maintain the scientific validity of the data. Data Monitoring Committees have evolved over the last four to five decades to meet the needs and challenges of stakeholders. 

Learning Points:

• The purpose and goals of Data Monitoring Committee
• The structure and function the DMC
• The roles and responsibilities of DMC members
• The activities of the sponsor that can contribute to a well-functioning DMC

Benefits of Attending:

Listeners will understand the critical importance of a thorough preparation of the DMC Charter.  This will help the sponsor focus on those activities that can improve the efficiency of the trial while protecting patients and maintaining data integrity.

Attendees Who Will Benefit From This Audio Conference Include:

• CROs
• Biotech
• Big Pharma
• new Clinical Research Associates
• new clinical managers
• new clinical medical monitors
• new safety physicians
• new risk management physicians

Dr. Paul Beninger
Dr. Paul Beninger is Vice President of Pharmacovigilance at Genzyme Corporation in Cambridge, Massachusetts, where he is responsible for maintaining the global safety profile of the company’s oncology drug products and biosurgical device products. He began his career in drug development in 1987 at the US Food and Drug Administration, first as a reviewer in CDER for drugs against HIV/AIDS and opportunistic infections and then as a division director in CDRH for medical devices. He joined Merck & Company in 1995, and developed experience in regulatory affairs, medical services and product safety in the areas of anti-infective drug and biological products, vaccines, and oncology drug products, before joining Genzyme in 2006. Dr. Beninger is trained in internal medicine and infectious diseases. He received his MD from University of California, Davis, his BA from Claremont McKenna College in Claremont, California, and his MBA from St Joseph’s University’s Executive MBA program in Philadelphia, Pennsylvania. He has published and spoken extensively on regulatory medicine and product safety, and he is a fellow of the American College of Physicians and the Infectious Disease Society of America.