Main description:

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

Contents:

Table of Contents

Clinical Trials Design in Invasive Operative and Non Operative Procedures

Editors: Kamal M.F. Itani, Domenic J. Reda

Section I: Basic Principles

Ch. 1: The Research Question and the Hypothesis

Peter R. Nelson

Ch. 2: Primary and Secondary Endpoints

Peter R. Nelson

Ch. 3: Intervention and Control Groups

Peter R. Nelson

Ch. 4: Subject Selection

Peter R. Nelson

Section II: Study Designs

Ch. 5: Clinical Phases of Device and Drug Evaluation with Emphasis on Early Phase Trials

Domenic J. Reda

Ch. 6: Overview of the Randomized Clinical Trial and the Parallel Group Design

Domenic J. Reda

Ch. 7: Non-Inferiority and Equivalence Trials

Domenic J. Reda

Ch. 8: Factorial Designs

Domenic J. Reda

Ch. 9: Cross-over Trials

Domenic J. Reda

Ch. 10: Cluster-Randomized Clinical Trials

William G. Hendreson

Ch. 11: Adaptive Trial Designs

Joshua S. Richman

Judy C. Boughey

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Ch. 12: Pragmatic Trials

Ryan E. Ferguson

Louis Fiore

Ch. 13: Point of Care Clinical Trials

Mary T. Brophy

Ryan E. Ferguson

Statistical Considerations

Ch. 14: Basic Statistical Considerations

Eileen M. Stock

Kousick Biswas

Ch. 15: Methods and Timing of Randomization

Robert George Edson

Ch. 16: Sample Size Calculation

Eileen M. Stock

Kousick Biswas

Ch. 17: Principles of Analysis

Gary R. Johnson

Tassos C. Kyriakides

Ch. 18: Advanced Statistical Methods

Hui Wang

Ilana Belitskaya-Levy

Mei-Chiung Shih

Ying Lu

Ch. 19: Missing Data

Kousick Biswas

Ch. 20: Interim Monitoring

Joseph F. Collins

Section IV: Ethical Considerations

Ch. 21: Ethical Considerations in Clinical Trials

Jennifer Tseng

Peter Angelos

Ch. 22: IRB and review process for multisite trials

Jennifer Tseng

Peter Angelos

Ch. 23: Trial advertising

Jennifer Tseng

Peter Angelos

Ch. 24: Payment to research participants

Jennifer Tseng

Peter Angelos

Ch. 25: Conflict of Interest

Jennifer Tseng

Peter Angelos

Section V: Considerations Specific to Surgical or Procedural Trials

Ch. 26: Quality Control in Procedural Studies

Nicole E. Lopez

Lawrence T. Kim

Ch. 27: Pilot Studies

Ryan E. Ferguson

Mary T. Brophy

Ch. 28: Surgeon training and the learning curve

Kamal M.F. Itani

Ch. 29: Using a placebo or sham procedure as a control: ethics and practicalities

Joshua S. Richman

Ch. 30: Patient Recruitment and Retention in Procedural Trials

Drew Moghanaki

Tomer Z. Karas

Ch. 31: Equipoise in Interventional Trials

Judy C. Boughey

Section VI: Regulatory Considerations

Ch. 32: Setting up a clinical trial research office

Kamal M.F. Itani

Ch. 33: Regulatory Considerations: The Clinical Research Coordinator

Marie Campasano

Kamal M.F. Itani

Ch. 34: Data Collection Forms

William G. Henderson

Marie Campasano

Ch. 35: Data Security

Jennifer M. Gabany

Kamal M.F. Itani

Ch. 36: Remote Monitoring of Data Quality

Jennifer M. Gabany

Ch. 37: Investigators meetings

Kamal M.F. Itani

Ch. 38: Site Visits

Kamal M.F. Itani

Ch. 39: Data Safety Monitoring Board: Composition and Role

Marco A. Zenati

William G. Henderson

Ch. 40: Endpoints committee

Leigh Neumayer

William G. Henderson

Ch. 41: Regulatory Issues with Devices in Clinical Trials

Gregory Campbell

Ch. 42: Trial registration and public access to data

Shachar Laks

Lawrence T. Kim

Yvonne Lucero

Section VII: Common Errors

Ch. 43: Mistakes in Clinical Trials<

William G. Henderson

Section VIII: Adjuncts to clinical trials

Ch. 44: Combined drugs and procedure trials

Ankur Kalra

Deepak L. Bhatt

Ch. 45: Genomics in Clinical Trials

Peter R. Nelson

Ch. 46: Biomarkers as Adjuncts to Clinical Trials

George Z. Li

Jiping Wang

Ch. 47: Patient-centered Designs (and Outcomes)

Frances M. Weaver

Ch. 48: Economic Evaluations

Denise M. Hynes

Leigh Neumayer

Ch. 49: Telemedicine and mobile technology

Heather L. Evans

Section IX: Budgeting

Ch. 50: Budgeting for a Clinical Trial

Eric L. Lazar

Section X: Funding

Ch. 51: Funding a Clinical Trial

Eric L. Lazar

Ch. 52: Writing Your Grant for the Patient Centered Outcomes Research Institute (PCORI)

Frances M. Weaver

Talar W. Markossian

Jennifer E. Layden

Ch. 53: Designing Clinical Trials for Quality and Impact: The Department of Veterans Affairs Approach to Developing a Cooperative Study

Grant D. Huang

Domenic J. Reda

Section XI: Publication

Ch. 54: Publication

J. Michael Gaziano