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

This book provides an overview of Data Monitoring Committees (DMCs) and their role in clinical trial evaluation, with a focus on practical implementation and hands-on information. It covers the steps needed to form and implement a DMC, discusses the impact of DMC activity on safeguarding the trial, and includes practical and hands-on information on DMC implementation across various clinical trial phases and therapeutic areas.

Format: Hardback
Length: 111 pages
Publication date: 09 June 2023
Publisher: Springer International Publishing AG

This book offers a comprehensive overview of Data Monitoring Committees (DMCs), covering their historical development, current practices, and potential enhancements for the future. While previous works primarily focused on large cardiovascular studies, this book recognizes the need for updated references that address smaller, more flexible studies in various clinical areas, including oncology. The authors have extensive experience attending DMC meetings from over 200 diverse studies across different therapeutic areas, including oncology, rheumatology, rare diseases, cardiology, immunology, and more. Their expertise spans working with biotechnology and pharmaceutical companies and clinical research organizations (CROs) for DMC work. The book aims to equip readers with the knowledge and skills necessary to determine when DMCs are required or beneficial, establish DMCs, collaborate effectively with external CROs and sponsor teams, and facilitate productive DMC meetings. It also provides valuable insights into the Closed Session process, where DMC members assess safety and efficacy outputs to evaluate risk-benefit and make appropriate recommendations to protect patient safety and trial integrity. This practical and hands-on guide offers guidance on various aspects of DMC work, including materials preparation, meeting conduct, and considerations for DMC members during the Closed Session. It serves as a valuable resource for individuals new to DMCs, as it provides a comprehensive understanding of their role and responsibilities. The book emphasizes the critical importance of DMC activity in safeguarding clinical trials, and its content aims to ensure that DMCs are implemented correctly and effectively.

Dimension: 235 x 155 (mm)
ISBN-13: 9783031287596
Edition number: 1st ed. 2023