| Description |
1 online resource : illustrations (some color) |
| 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 |
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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 |
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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 |
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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 |
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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 |
| 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 |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Clinical trials.
|
|
Ensayos clínicos
|
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Clinical trials
|
|
Assaigs clínics.
|
| Genre/Form |
Llibres electrònics.
|
| Form |
Electronic book
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| Author |
Piantadosi, Steven, editor.
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|
Meinert, Curtis L., editor.
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| ISBN |
9783319526362 |
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3319526367 |
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