Data Monitoring Committees (DMCs)

Introduction-.What is a DMC?-. Is a DMC required?-. Who is On the DMC?-. What are the Legal and Ethical Aspects of DMC?-. How does the DMC work with SDAC and Sponsor and External Groups ?.- What Does a DMC Meeting Look Like.- What data is used for DMC outputs and who programs?.- What is Included in DMC Outputs?.- What does the DMC final DMC outputs look like and how is it delivered?.- What Types of Safety Outputs Does the DMC Receive?.- What types of efficacy outputs does the DMC receive?.- What types of other outputs does the DMC receive?.- What About In-Between DMC Meetings.- What types of formal interim analyses does the DMC review?.- What does the paperwork from meetings look like?.- How does the DMC assess risk-benefit for their decision making?.- What are some examples?.- Conclusions.

Dr. Nand Kishore Rawat

Dr. Rawat has 18 years of experience working in the Biostatistics domain at various pharmaceutical companies (BMS, Novartis and Sun Pharmaceutical) and at Clinical Research Organizations (Cytel and Accutest). Dr. Rawat primarily worked on Early phase clinical trials and led the Early phase division at Cytel. Prior to Lantheus, he worked at Cytel for the 9 years in the scientific leadership and strategic management role in the Early phase as well as Data Monitoring Committees (DMCs).He is a strong advocate for process improvements and has presented at several international conferences. He has a Ph.D. in Statistics and has six publications and one book published in his credit. Currently he is working in the capacity of Director, Biostatistics at Lantheus and providing leadership, strategic direction, and oversight to Biometrics Department globally.



David Kerr

David Kerr received his Master's in Statistics from the University of Washington and has worked at Axio Research, now part of Cytel, in Seattle for the past 27 years. He currently holds the title of Director of DMC Services where he provides leadership, direction, and oversight for DMC services provided by Axio/Cytel- which facilitates approximately 400 DMC meetings per year. He was instrumental in developing Axio/Cytel's SOPs which govern the company's DMC Services.

In addition to his duties as Director of DMC Services, David has himself provided statistical support as the reporting statistician for more than 175 DMCs covering 250 individual clinical trials, with particular emphasis in disease areas such as oncology, cardiology, infectious disease, respiratory disease, and rheumatology. He has personally attended over 750 DMC meetings and seen a wide variety of situations from those experiences. He is a strong advocate for improvements in the DMC process and has presented at many conferences, as well as given tutorials to industry. His goal is