Bücher von David Kerr

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 is a practical hands-on book on how to decide if a DMC is necessary, how to form the DMC, how to expertly create the necessary materials for the DMC and have smooth running DMC meetings. There is no specialized training in school about how DMCs work - frequently people may have been in industry for many years without ever needing to work with a DMC. This book is the helpful reference for those new to these DMCs. The DMC work is critical to be correctly implemented as the impact of DMC activity on safeguarding the trial is so important.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.

The advent of the World Wide Web has changed the perspectives of groupware systems. The interest and deployment of Internet and intranet groupware solutions is growing rapidly, not just in academic circles but also in the commercial arena. The first generation of Web-based groupware tools has already started to emerge, and leading groupware vendors are urgently adapting their products for compatibility and integration with Web technologies. The focus of Groupware and the World Wide Web is to explore the potential for Web-based groupware. This book includes an analysis of the key characteristics of the Web, presenting reasons for its success, and describes developments of a diverse range of Web-based groupware systems. An emphasis on the technical obstacles and challenges is implemented by more analytical discussions and perspectives, including that of Information Technology managers looking to deploy groupware solutions within their organizations. Written by experts from different backgrounds - academic and commercial, technical and organizational - this book provides a unique overview of and insight into current issues and future possibilities concerning extension of the World Wide Web for group working.

This book provides an introduction to the ergodic theory and topological dynamics of actions of countable groups. The more advanced material includes Popa's cocycle superrigidity, the Furstenberg-Zimmer structure theorem, and sofic entropy. The structure of the book is designed to be flexible enough to serve a variety of readers.