This book gives a general overview of Data Monitoring Committees (DMC) including what has been done in the past, what is being done now, and suggestions for future improvements. DMCs were first employed in big cardiovascular research more than 30 years ago; however, more recent references should cover smaller, more adaptable studies in fields like oncology. The authors have participated in 800 DMC meetings from 200 different clinical studies (oncology, rheumatology, rare illnesses, cardiology, immunology, etc.) that span all clinical study subfields. This broad spectrum of knowledge will be applied, together with the knowledge gained through working with almost every major biotechnology and pharmaceutical business and CRO for DMC work.
When DMCs are necessary or helpful, how to form a DMC, how to collaborate with sponsor teams, external CROs, and the DMC to produce necessary DMC outputs, how DMC meetings are conducted, and – particularly for DMC members – what considerations are within the Closed Session to review safety/efficacy outputs to assess risk/benefit, and how to make appropriate recommendations that safeguard patient safety and trial integrity will all be known to the reader of the book.
This book provides step-by-step instructions on how to organize a DMC, evaluate whether one is needed, develop the materials it needs, and conduct effective DMC meetings. Nobody receives specific instruction regarding how DMCs operate in school; in many cases, people work in the sector for years without ever having to interact with a DMC. For individuals who are unfamiliar with these DMCs, this book is a useful resource. The DMC work must be implemented correctly because it has a significant impact on protecting the trial.
The following is provided in this book:
detailed directions on how to set up and operate a Data Monitoring Committee for clinical trial review; includes material that may be used immediately;
explains a variety of clinical trials, broken down by phase and therapeutic area.
