Data Monitoring Committees Dmcs Past Present And Future Nand Kishore Rawat by Nand Kishore Rawat, David Kerr 9783031287596, 3031287592 instant download after payment.

This book provides an overview of Data Monitoring Committees(DMC) - what was done in the past, what is currently being done, and thoughts on improvements for the future. Previous works focused primarily on large cardiovascular studies (where DMCs originated more than 30 years ago) but updated references are needed that discuss smaller, more flexible studies in areas such as oncology. The authors have attended ~800 DMC meetings from ~200 distinct studies across all areas of clinical studies (oncology, rheumatology, rare diseases, cardiology, immunology, etc.) This wide range of expertise will be used, as well as the expertise that comes from working with virtually every large biotechnology and pharmaceutical company and CRO for DMC work. The reader of the book will know when DMCs are needed or helpful, how to form the DMC, how to work with external CROs and with sponsor teams and the DMC to create needed DMC outputs, how the DMC meetings are conducted, and - especially for DMC members - what are considerations within the Closed Session to review safety/efficacy outputs to assess risk/benefit to make appropriate recommendations that protect the patient safety and trial integrity.

This book provides the following:

• Provides thorough instructions on the steps needed to form and implement a Data Monitoring Committee for clinical trial evaluation;
• Includes practical and hands-on information on DMC implementation;
• Discusses a wide range of clinical trial – by phase and therapeutic area.