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Foreword I; Foreword II; Preface; Acknowledgements; Contents; Contributors; Basic Principles; 1 The Research Question and the Hypothesis; The Research Question; Getting Started; Does Your Idea Show Promise?; Refining Your Thoughts; Secondary Research Questions; The Hypothesis; "Practical Exercise"; Summary; References; 2 Primary and Secondary Endpoints; General Concepts; Measurement; The Primary Endpoint; Secondary Endpoints; Pros and Cons of Common Endpoints; Mortality; Morbidity; Pain; Procedural Outcomes; Pharmaceutical; Molecular Information; Quality of Life; Economics/Costs.

"Practical Exercise"Summary; References; 3 Intervention and Control Groups; General Concepts; Interventions; Pharmacologic Intervention; Procedural Intervention; Patient Care Intervention; Control Groups; Blinding; "Practical Exercise"; Summary; References; 4 Subject Selection; General Concepts; Inclusion Criteria; Exclusion Criteria; Vulnerable Populations; Informed Consent; "Practical Exercise"; Summary; References; Study Designs; 5 Clinical Phases of Device and Drug Evaluation with Emphasis on Early Phase Trials; Overview of Regulatory Phases for Investigational Agents.

Clinical Research Milestones Before the Advent of the Modern Randomized Clinical TrialStreptomycin for the Treatment of Tuberculosis; The Benefits of Randomization; Trial Timing; Ethics; Feasibility; Randomization Is Not Enough, What Happens After Randomization Is Just as Important; The Two-Parallel-Group Trial; The Multiple-Parallel-Group Trial; Example; Conclusion; References; 7 Non-inferiority and Equivalence Trials; Overview; Hypothesis Testing; Confidence Interval Approach for Equivalence and Non-inferiority Trials.

Example: Oral Versus Intratympanic Steroids for Treatment of Idiopathic Sudden Sensorineural Hearing LossExample: ACOSOG Z6051-Laparoscopic-Assisted Resection Versus Open Resection of Stage II or III Rectal Cancer; Choosing a Non-inferiority Design Versus a Traditional Parallel Group Design; Choice of the Non-inferiority (or Equivalence) Margin; Non-inferiority Is Not Transitive; Poor Study Conduct Makes Establishing Non-inferiority Easier; Guidance on Non-inferiority Trials; Summary; References; 8 Factorial Designs; Definitions and Examples of Factorial Designs.

Regulatory Phases for Device ApprovalFeasibility Study; Pivotal Study; Regulatory Phases for Trials of Drugs, Vaccines and Biologics; Phase 0 Trials; Phase I Clinical Studies; Estimation of Initial Safety and Tolerability; Pharmacokinetics/Pharmacodynamics (PK/PD); Early Measurement of Drug Activity; Phase I Trial Designs; Phase II Clinical Studies; Phase IIa Studies; Proof of Concept Studies; Example; Phase IIb Studies; Phase II Trial Designs; Phase III Clinical Studies; Procedural Trials; References; 6 Overview of the Randomized Clinical Trial and the Parallel Group Design.

The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results. The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry. Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists.

Online resource; title from PDF title page (SpringerLink, viewed June 1, 2017).