Principles and practice of clinical trials

This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Intro -- A Foreword to the Principles and Practice of Clinical Trials -- Preface -- Acknowledgments -- Contents -- About the Editors -- About the Section Editors -- Contributors -- Part I: Perspectives on Clinical Trials -- 1 Social and Scientific History of Randomized Controlled Trials -- Introduction -- Early History of Clinical Trials -- Refining Trial Methods in the Early Twentieth Century -- The Role of Governments in the Institutionalization of Randomized Controlled Trials -- Historical Trial Ethics -- RCTs and Evidence-Based Medicine

The Globalization of RCTs and the Challenges of Similarities and Differences in Global Populations -- Social and Scientific Challenges in Randomized Controlled Trials -- Summary and Conclusion -- Key Facts -- Cross-References -- References -- 2 Evolution of Clinical Trials Science -- Introduction -- The Scientific MethodScience is the study of natural phenomena, which are accessible to both passive and active observation. P... -- Some Key Evolutionary Developments -- Ethics

Governance ModelsRunning a clinical trial in the modern world is not simple and requires some unique governance features. Whil... -- Computerization -- Statistical Advance…