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Table of 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
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