Data Monitoring Committees (DMCs) Past, Present, and Future

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).

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 to make sure the DMC has the best information available to help them make educated recommendations for the success of the trial and the protection of the study participants.