Clinical trials for surgeons: Hurdles and opportunities

Clinical trials provide some of the highest level of evidence for advances in practice. However, successful clinical trials require input and support from surgeons across the nation. Although many surgeons find clinical trials intriguing, show interest in their outcomes, and have participated in trials in an on-the-job, ad hoc manner, few surgeons have had a formal introduction to the basics of clinical trials research.

Learn about clinical trials at SSO meeting

To help provide a more systematic introduction to surgeons interested in clinical trials, the American College of Surgeons Clinical Research Program (ACS CRP) has partnered with the Society of Surgical Oncology (SSO) to develop an educational program titled Clinical Trials for Surgeons: Hurdles and Opportunities. This two-hour session will take place Friday, March 23, at the SSO annual meeting in Chicago, IL.

This session will provide a practical and organized toolbox for surgeons who are interested in actively participating in these studies at their own institutions. The specific areas that will be covered in the course include National Institute of Health oversight of clinical trials research, ethical issues pertaining to research involving human subjects, roles and responsibilities of the participating principal investigator and institution, trial protocol structure, and practical issues associated with trial implementation.

Kelly K. Hunt, MD, FACS, principal investigator and Director, ACS CRP, will begin the course with an overview of the National Cancer Institute (NCI) cooperative groups and the NCI’s previous and current structure, as well as a discussion of how past surgical oncology trials have changed the management of patients today. Without the evidence provided by these clinical trials, data would not be available to guide the advances in practice that have occurred in recent years.

The second part of the session will center on how a surgical trial investigator can navigate the national and local infrastructure of clinical trials research. Matthew H.G. Katz, MD, FACS, Chair, ACS CRP Cancer Standards Development Committee, will discuss national oncology trial cooperative groups, trial sponsors, and regulatory bodies and—based on his experience as the national principal investigator of Alliance trial A021101—a neoadjuvant chemoradiation study in pancreatic cancer. Eleftherios Mamounas, MD, MPH, FACS, medical director, Comprehensive Breast Program, University of Florida Health Cancer Center, Orlando, will then provide a case study using the NRG B-51 trial that looks at the possibility of avoiding radiation in patients with breast cancer with a complete response to neoadjuvant chemotherapy.

The final part of the session will focus on the fundamentals of becoming involved in clinical trials, whether at an academic institution or in the community. Darren Carpizo, MD, PhD, FACS, director, hepatobiliary program, and surgical oncologist, Rutgers Cancer Institute of New Jersey, New Brunswick, will provide an overview of opportunities for university surgical oncologists, focusing on correlative sciences, cancer care delivery research, and multicenter trials outside of the cooperative groups. Gary Unzeitig, MD, FACS, a breast surgeon from Laredo, TX, will then discuss opportunities for the community surgical oncologist. Finally, Y. Nancy You, MD, MHSc, FACS, Vice-Chair, ACS CRP Education Committee, will provide a case study highlighting these components as they pertain to the Alliance Preoperative Radiation or Selective Preoperative Radiation and Evaluation before Chemotherapy and TME [total mesorectal excision] (PROSPECT) trial.

Get involved

Getting involved in clinical trials is straightforward for those interested in and passionate about improving cancer patient care. The ACS CRP is dedicated to educating surgeons on clinical trials research. Feedback from the course presented at the SSO annual meeting will provide the ACS CRP Education Committee with information on areas to target for future educational programs, including courses and panel sessions at the ACS Clinical Congress.

In addition to the session at SSO, there will be an ACS CRP investigators luncheon Saturday, March 24, which is open to all interested parties. For more information or for opportunities to participate, contact Amanda Francescatti, Senior Manager, ACS CRP, at afrancescatti@facs.org.

 

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