BookSteven Piantadosi, Curtis L. Meinert, editors.
Summary: 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.
Contents:
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 Advances
A Likely Future
Final Comments
Key Facts
Cross-References
References
3 Terminology: Conventions and Recommendations
Introduction
Clinical Trial
Trial Versus Study
Pilot Study Versus Feasibility Study
Name of Trial
Name of the Experimental Variable: Treatment Versus Intervention
Name for Groups Represented by Experimental Variable: Study Group, Treatment Group, or Arm Persons Studied: Subject, Patient, or Participant
Trial Protocol Versus Manual of Operations
Blocking Versus Stratification and Quotafication
Open
Controlled
Placebo
Consent
Randomization Versus Randomized
Registration Versus Enrollment
Single Center Trial Versus Multicenter Trial
Multicenter Versus Cooperative Versus Collaborative
Principal Investigator (PI) Versus Study Chair
Clinical Investigator Versus Investigator
Steering Committee Versus Executive Committee
Data Monitoring Versus Data Monitoring Committee
Random Versus Haphazard Primary Versus Secondary Outcomes
Outcome Versus Endpoint
Treatment Failure Versus Treatment Cessation
Blind Versus Mask
Lost to Followup
Dropout
Withdrawals
Design Variable Versus Primary Outcome Measure
Baseline Versus Baseline Period
Screened Versus Enrolled
End of Followup Versus End of Trial
Analysis by Assigned Treatment Versus Per Protocol Analysis
Bias
Early Stop Versus Nominal Stop
Summary
References
4 Clinical Trials, Ethics, and Human Protections Policies
Origins of Research Ethics
Conception of Trials
Design of Trials