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).

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 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.

Dr. Nand Kishore Rawat

Dr. Rawat 在生物統計領域擁有 18 年的經驗，曾在多家製藥公司（BMS、Novartis 和 Sun Pharmaceutical）及臨床研究機構（Cytel 和 Accutest）工作。Dr. Rawat 主要專注於早期階段的臨床試驗，並在 Cytel 領導早期階段部門。在加入 Lantheus 之前，他在 Cytel 工作了 9 年，擔任科學領導和戰略管理角色，負責早期階段及數據監控委員會（DMCs）。

他是流程改進的堅定倡導者，並在多個國際會議上發表過演講。他擁有統計學博士學位，並有六篇出版物和一本書籍發表。目前，他在 Lantheus 擔任生物統計部門主任，負責全球生物統計部門的領導、戰略方向和監督。

David Kerr

David Kerr 於華盛頓大學獲得統計學碩士學位，並在位於西雅圖的 Axio Research（現為 Cytel 的一部分）工作了 27 年。他目前擔任 DMC 服務主任，負責 Axio/Cytel 提供的 DMC 服務的領導、指導和監督，每年約舉辦 400 次 DMC 會議。他在制定 Axio/Cytel 的標準作業程序（SOPs）方面發揮了重要作用，這些程序規範了公司的 DMC 服務。

除了擔任 DMC 服務主任的職責外，David 還擔任過超過 175 個 DMC 的報告統計師，為 250 個個別臨床試驗提供統計支持，特別強調腫瘤學、心臟病學、傳染病、呼吸系統疾病和風濕病等疾病領域。他親自參加了超過 750 次 DMC 會議，並從這些經驗中見識了各種情況。他是 DMC 流程改進的堅定倡導者，並在許多會議上發表過演講，還為業界提供過教程。他的目標是確保 DMC 擁有最佳資訊，以幫助他們為試驗的成功和研究參與者的保護做出明智的建議。