Clinical Trials Design in Operative and Non Operative Invasive Procedures (eBook)

Kamal MF Itani MDVABHCS(112A)1400 VFW ParkwayWest Roxbury, MA 02132Domenic Reda PhDHines CSP Coordinating Center5000 South 5th AvenueHines, IL 60141Kamal M. F. Itani, MD, Chief of surgery at the VA Boston Health Care System is a Professor of Surgery at Boston University. Dr Itani attended medical school at the American University of Beirut, residency in surgery at Baylor College of Medicine and a research fellowship in the Department of Surgery at Duke University. Prior to his move to Boston, Dr. Itani was an Associate Professor in the Michael E. DeBakey Department of Surgery and The Assistant Dean for Graduate Medical Education at Baylor College of Medicine. He was also Chief of General Surgery at the Houston VA Medical Center and a staff surgeon at The Ben Taub General Hospital.Dr. Itani’s primary clinical interest is in surgical infections, hernia repair and surgical education with a research focus on the improvement of health services and surgical outcomes within his areas of clinical interest. He is the author or co-author of more than 150 peer-reviewed journal articles, editorials, and book chapters and is the lead investigator on several clinical trials. Dr Itani is a member of various surgical organizations and has served in various leadership positions in these organizations. He currently sits on several National committees including the VA Surgical quality improvement project (VASQIP), the research committee of the American College of Surgeons,  and chairs the surgical quality data use group (SQDUG), the research arm of VASQIP. He is also the course director for the American College of Surgeons clinical trials course since 2007. He is a member of the editorial board of the American Journal of Surgery, Surgical Infection, Hospital Physician, and is a reviewer for several medical and surgical journals. In addition to his various leadership roles in various surgical associations and societies, he is past President of The Association of VA Surgeons.

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

 

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-Lévy

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

            Thomas H. Shoultz 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