The American College of Surgeons (ACS) Oncology Group, active from 1998 to 2011, played a pivotal role in increasing surgeon participation in cancer clinical trials research.* The ACS Clinical Research Program (CRP), established in 2014, continues to work to increase surgeon participation in clinical research. This column describes two opportunities at Clinical Congress 2019, San Francisco, CA, to learn about developing clinical trials and decreasing the administrative burden associated with surgeon participation in clinical trials.
Didactic Course on developing prospective trials
Surgeons often have limited exposure to clinical trials until they are in active clinical practice. Consequently, they may learn to participate in these trials on the job and in an as-needed fashion. At present, no formal curriculum focuses on clinical trials research during surgical residency or surgical specialty fellowship training, and although clinical trials courses and workshops are available to practicing physicians, most are intensive and require several days away from practice.†
To address this gap, the ACS CRP and the ACS Surgical Research Committee are offering a Didactic Course at Clinical Congress 2019 titled Designing and Running a Prospective Surgical Clinical Trial (DC06), 8:30 am–4:00 pm, October 27. This course, chaired by Judy C. Boughey, MD, FACS, and Kamal M.F. Itani, MD, FACS, two co-authors of this month’s column, is designed to teach the methodology used to design, implement, and oversee a clinical trial for surgeons interested in developing and leading a prospective trial. The course will cover the following related topics:
- Ethics and equipoise
- Hypothesis development
- Trial design
- Statistics
- Patient selection
- Surgeon credentialing
- Correlative aspects
- Budget development and funding sources
- Trial implementation and regulatory aspects
- Industry sponsors and the National Clinical Trials Network
- Trial publication and manuscript development
The speakers have broad expertise in general surgery, pediatric surgery, surgical oncology, statistics, and journal management. Presentations will include real-life examples, including personal successes and pitfalls in clinical trial development and manuscript publication, and well-designed surgical trials will be discussed throughout the course.
Registration for the course opens in June, and will be a unique opportunity for trainees, young faculty, and mid-career faculty to learn more about clinical trials and enable them to be more proficient in developing clinical trials.
The ACS Cancer Programs will provide scholarships for up to 20 general surgery residents who are Members of the Resident and Associate Society to attend this course. Scholarship details will be available online in June.
Special Interest Session: Unlocking administrative barriers
Whether practicing in the community, in private practice, or in a university setting, administrative requirements to enroll patients in clinical trials can be burdensome. A Special Interest Session, Enrolling to Clinical Trials: One-on-One Workshop with ACS Staff Members to Unlock Administrative Barriers, scheduled for 7:00 am–4:00 pm, October 29, will provide surgeons with the opportunity to drop in and work with a dedicated ACS CRP staff member to facilitate completion of required trainings and requirements. Staff members will be available all day to guide surgeons through training on topics such as research ethics, compliance, and good clinical practice applications. Attend this workshop to learn about the requirements as well as open clinical trials specifically designed for surgery patients.
The ACS CRP strives to educate surgeons in clinical trials research and provide surgeons with the resources to meet the necessary regulatory requirements for clinical trials participation. These efforts will facilitate surgeon involvement and leadership in clinical trials research to benefit our future patients. For information about either of these programs, contact ACS CRP staff at clinicalresearchprogram@facs.org.
*Rusch VW. Surgeons: A future role in clinical trials? Oncologist. 1997;2(3):V-VI.
†American Society of Clinical Oncology (ASCO). ASCO/AACR Workshop on Methods in Clinical Cancer Research. About the workshop. Available at: https://vailworkshop.org/Pages/AboutWorkshop.aspx. Accessed May 2, 2019.
