Successful randomized trials a handbook for the 21st century

This handbook is a ready reference on the theory and operation of modern large, multicenter randomized clinical trials, which have come to be the basis of evidence-based medicine. Written in a concise, engaging style geared to physicians, the book explains the rationale and theoretical foundations for clinical trials, the components of modern clinical trials including their functions and interactions, and practical considerations in the design and implementation of these studies including an introduction to the economics and business aspects.

CLINICAL TRIAL PRINCIPLES

Randomized Clinical Trials
Michael Domanski and Sonja McKinlay

Designing Clinical Trials
Susan F. Assmann

Randomization: What It Is and How to Do It
Catherine E. Hewitt and David J. Torgerson

Setting Sample Size for Randomized Clinical Trials
Xin Tian, Sonja M. McKinlay and Nancy L. Geller

Analytic Approach and Methods
Lynn Sleeper

Ethical Considerations
Lawrence M. Friedman and Eleanor B. Schron

LARGE MULTICENTER TRIALS: STRUCTURE AND CONDUCT

Study Organization and Governance
Abdel Babiker

Quality Assurance and Quality Control
Sandi Siami

Quality Assurance: Prevention of Missing Data
James Neaton

THE FUTURE

Surrogate Endpoints
Robert Fiorentino

Registries
Hesha Duggirala

Gazing Into the Crystal Ball: The Future of Randomized Clinical Trials
Michael Domanski, Sonja McKinlay, and Marc Pfeffer