Böcker av 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.

Coverage includes: How to use good design and careful construction to create the conditions necessary for plants and animals to thrive in and around your pond. Detailed step-by-step guides for different pond sizes and functions. Especially useful for those planning natural swimming ponds and other large ponds. How to choose the right plants to avoid problems with nuisance species, incorporating a buyer's guide to aquatic plant purchases. Over 250 full-colour plant pictures with descriptions. Propagation and maintenance. Practical ways to avoid pitfalls, prevent problems from developing and solutions to those problems should they occur.

Explores the range of vibrant cultural production and political activism of youth in Africa today, as expressed through art, music, theater, and online media.This edited collection focuses on the links between youth and African popular culture. Contributions by a distinguished group of scholars explore popular culture produced and consumed by young people in contemporary Africa. Essays cover a variety of cultural representations--visual, oral, written, performative, fictional, social, and virtual--created by African youth, mostly about their lives and their immediate societies, and for themselves, but also consumed by the larger public and shared locally and globally. The volume examines the range of music, art, and media African youth produce, under what conditions or contexts they produce such work, and the aesthetic dimensions of these texts as cultural artifacts. Essays further explore why these textual practices matter as social facts, as interpretive acts, and as symbols of the cultural activism of young people in a rapidly changing world-a world where the global cultural economy is the prime terrain for the relentless struggles over the meanings that come to shape political-economic and social systems.

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.