ACS Clinical Research Program

Designing and Running a Prospective Surgical Clinical Trial Course

The American College of Surgeons Clinical Research Program (ACS CRP) and the ACS Surgical Research Committee co-sponsored this course at ACS Clinical Congress 2019.

This course is designed to teach the methodology of design and implementation of a clinical trial for surgeons interested in developing and leading a prospective trial. Topics include

  • Hypothesis development
  • Trial design and implementation
  • Statistical concepts
  • Ethics and equipoise
  • Patient selection
  • Trial management and monitoring
  • Budget development and funding sources
  • Dissemination of results

The course will provide surgeons the opportunity to learn how to design and conduct high-level clinical trials to evaluate treatment methods and procedures to advance the care of the surgical patients.

Target Audience

  • Practicing surgeons
  • Surgical residents
  • Health care professionals involved in surgical clinical research

Learning Objectives

  • Define requirements for a good research question and hypothesis, steps for planning and executing clinical trials, and the ethical considerations behind clinical research
  • Recognize the underlying basic statistical principles of clinical trials, the importance of data monitoring and surgeon credentialing, and primary endpoints of correlative studies
  • Explain how to budget and fund a clinical trial
  • Describe how to get involved in cooperative groups and how to prepare for trial publication

Contact

Course summary
Available credit: 
  • 5.50 AMA PRA Category 1 Credit™
  • 5.50 Certificate of Completion
  • 5.50 Self Assessment Credit
Course opens: 
07/01/2020
Course expires: 
07/31/2023

Disclosure Information

In accordance with the ACCME Accreditation Criteria, the American College of Surgeons must ensure that anyone in a position to control the content of the educational activity (planners and speakers/authors/discussants/moderators) has disclosed all relevant financial relationships with any commercial interest (see below for definitions).

Commercial Interest

The ACCME defines a “commercial interest” as any entity producing, marketing, re-selling, or distributing health care goods or services used on or consumed by patients. Providers of clinical services directly to patients are NOT included in this definition.

Financial Relationships

Relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received, or expected. ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.

Conflict of Interest

Circumstances create a conflict of interest when an individual has an opportunity to affect CME content about products or services of a commercial interest with which he/she has a financial relationship.

The ACCME also requires that ACS manage any reported conflict and eliminate the potential for bias during the educational activity. Any conflicts noted below have been managed to our satisfaction. The disclosure information is intended to identify any commercial relationships and allow learners to form their own judgments. However, if you perceive a bias during the educational activity, please report it on the evaluation.

Speakers, Moderators, Chairs

CHAIR:
Judy C. Boughey, MBBCh, FACS – Nothing to disclose
Professor of Surgery, Mayo Clinic, Rochester, MN

CO-CHAIR:
Kamal M. Itani, MD, FACS - Eupraxia pharmaceuticals: Consulting Fee: Consultant, Pfizer: Institutional grant: PI
Chief of Surgery VABHCS, Professor of Surgery, Boston University, VA Boston Healthcare System, Surgical Service, West Roxbury, MA

Peter R. Nelson, MD, MS, FACS – Nothing to disclose
Professor of Surgery, Vascular Surgery, University of Oklahoma, Tulsa, OK 

Matthew H.G. Katz, MD, FACS – Nothing to disclose
Associate Professor, MD Anderson Cancer Center, Department of Surgical Oncology, Division of Surgery, Houston, TX 

Karla V. Ballman, PhD - Eli Lilly: Honorarium: Expert witness for Cialis and Melanoma
Johnson and Johnson: Honorarium: Expert witness for talcum power and ovarian cancer
Johnson and Johnson: Honorarium: Expert witness in abiraterone patent infringement case
Takeda: Honorarium: Data Safety and Monitoring Committee (trial using brigatinib)

Professor and Chief of Biostatistics and Epidemiology, Weill Cornell Medicine, New York, NY 

James W. Fleshman, MD, FACS – Nothing to disclose
Chief of Surgery, Baylor University Medical, Department of Surgery, Dallas, TX 

Eric L. Lazar, MD, MS, FACS – Nothing to disclose
Associate Professor of Surgery, Rutgers University New Jersey Medical School, Mendham, NJ 

George A. Sarosi, MD, FACS – Nothing to disclose
Professor, NF/SG VA Medical Center, Gainesville, FL 

Anna Weiss, MD – Nothing to disclose
Assistant Professor of Surgery, Dana-Farber/Brigham & Women’s Cancer Center, Boston, MA 

Edward H. Livingston, MD, FACS – Nothing to disclose
Chief Editor for JAMA, Adjunct Professor of Surgery, University of Texas Southwestern School of Medicine, Northwestern University, Chicago, IL

 

Program Committee and Disclosures

Amanda Francescatti, MS – Nothing to disclose
Linda Zheng – Nothing to disclose
 

Planning Committee

CHAIR:
Judy C. Boughey, MBBCh, FACS – Nothing to disclose
Professor of Surgery, Mayo Clinic, Rochester, MN

CO-CHAIR:
Kamal M. Itani, MD, FACS - Eupraxia pharmaceuticals: Consulting Fee: Consultant, Pfizer: Institutional grant: PI
Chief of Surgery VABHCS, Professor of Surgery, Boston University, VA Boston Healthcare System, Surgical Service, West Roxbury, MA

Peter R. Nelson, MD, MS, FACS – Nothing to disclose
Professor of Surgery, Vascular Surgery, University of Oklahoma, Tulsa, OK 

Matthew H.G. Katz, MD, FACS – Nothing to disclose
Associate Professor, MD Anderson Cancer Center, Department of Surgical Oncology, Division of Surgery, Houston, TX 

Karla V. Ballman, PhD - Eli Lilly: Honorarium: Expert witness for Cialis and Melanoma
Johnson and Johnson: Honorarium: Expert witness for talcum power and ovarian cancer
Johnson and Johnson: Honorarium: Expert witness in abiraterone patent infringement case
Takeda: Honorarium: Data Safety and Monitoring Committee (trial using brigatinib)

Professor and Chief of Biostatistics and Epidemiology, Weill Cornell Medicine, New York, NY 

James W. Fleshman, MD, FACS – Nothing to disclose
Chief of Surgery, Baylor University Medical, Department of Surgery, Dallas, TX 

Eric L. Lazar, MD, MS, FACS – Nothing to disclose
Associate Professor of Surgery, Rutgers University New Jersey Medical School, Mendham, NJ 

George A. Sarosi, MD, FACS – Nothing to disclose
Professor, NF/SG VA Medical Center, Gainesville, FL 

Anna Weiss, MD – Nothing to disclose
Assistant Professor of Surgery, Dana-Farber/Brigham & Women’s Cancer Center, Boston, MA 

Edward H. Livingston, MD, FACS – Nothing to disclose
Chief Editor for JAMA, Adjunct Professor of Surgery, University of Texas Southwestern School of Medicine, Northwestern University, Chicago, IL

Amanda Francescatti, MS – Nothing to disclose
Linda Zheng – Nothing to disclose

Continuing Medical Education Credit Information

Accreditation

The American College of Surgeons is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

AMA PRA Category 1 Credits™

The American College of Surgeons designates this enduring activity for a maximum of 5.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Of the AMA PRA Category 1 Credits™ listed above, a maximum of 5.5 credits meet the requirements for Self-Assessment.

American College of Surgeons and ACGME Logos

Note: Residents will receive a Certificate of Completion.

 

Available Credit

  • 5.50 AMA PRA Category 1 Credit™
  • 5.50 Certificate of Completion
  • 5.50 Self Assessment Credit
Please login or register to take this course.

Course Fee

The following is the course fee for each category. You will be asked to register for the course and provide payment information to complete the registration process. 

Fellows -  $125
Resident Member  -  $100