CTM CLINICAL TRIALS METHODS COURSE. November 6 10, 2015 ACS Headquarters Chicago, IL

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1 CTM CLINICAL TRIALS METHODS COURSE November 6 10, 2015 ACS Headquarters Chicago, IL Sponsored by the Surgical Research Committee, Division of Research and Optimal Patient Care

2 Course Description and Objectives The Clinical Trials Methods Course provides a five-day intensive course based on four successfully conducted and published clinical trials. Expert faculty will use a combination of didactic lectures and hands-on approaches, including break-out sessions, to apply concepts learned throughout the course. The course is designed to provide surgical investigators with the concepts necessary to: Develop a protocol for a clinical trial that is fundable by a peer-reviewed agency Understand the statistical concepts necessary to design a clinical trial Understand the design and implementation issues unique to performing surgical trials Foster the collaborative efforts necessary to conduct a clinical trial Course Content The course features lectures and small group breakout sessions to address the following topics: Design and types of clinical trials Determining the research hypothesis and research components Statistical concepts, inference, hypothesis testing, and sample size Developing a study proposal Experimental design for a randomized clinical trial Publication dissemination of results, who owns the data Interventions and endpoints Planning measurements Trial management Clinical trials methods analysis Industry-funded trials Ethics issues Peer review and funding sources Presentation of proposals and critiques REGISTER facs.org/quality-programs/about/cqi/education/clintrial

3 Schedule DAY 1 FRIDAY, NOVEMBER 6 8:00 9:30 am Review of Four Clinical Trials Kamal F. Itani, MD, FACS 9:30 10:30 am Statistics I 10:30 11:00 am Break 11:00 am 12:00 noon Statistics II Jody D. Ciolino, PhD 12:00 noon 1:00 pm Lunch 1:00 2:00 pm Overview of Design Options for Clinical Trials George A. Sarosi, Jr., MD, FACS 2:00 3:00 pm The Question and End Points Peter R. Nelson, MD, MS, FACS 3:00 5:00 pm Group Breakout Sessions DAY 2 SATURDAY, NOVEMBER 7 8:00 9:00 am Patient Selection Lawrence T. Kim, MD, FACS 9:00 10:00 am Experimental Design for a Randomized Clinical Trial Robert J. Anderson, PhD 10:00 10:30 am Break 10:30 11:30 am Statistical Inference, Hypothesis Testing, and Sample Size 11:30 am 12:30 pm Interventions Judy C. Boughey, MBBCh, FACS 12:30 1:30 pm Lunch 1:30 5:30 pm Group Breakout Sessions 6:30 8:00 pm Group Dinner DAY 3 SUNDAY, NOVEMBER 8 8:00 9:00 am Statistical Concepts in Clinical Trials Joseph F. Collins, ScD 9:00 10:00 am Publication of Results Layton F. Rikkers, MD, FACS 10:00 10:30 am Break 10:30 11:30 am Ethical Considerations in Clinical Trials Peter Angelos, MD, PhD, FACS 11:30 am 12:30 pm Clinical Trials Analysis Methods 12:30 1:30 pm Lunch 1:30 5:30 pm Group Breakout Sessions DAY 4 MONDAY, NOVEMBER 9 6:30 7:30 am Continental Breakfast 7:30 8:30 am Putting It All Together: How to Get a Clinical Trial Paid For Eric L. Lazar, MD, FACS 8:30 9:30 am Trial Management and Planning Measurements Joshua S. Richman, MD, PhD 9:30 10:00 am Break 10:00 11:00 am Mistakes in Clinical Trials 11:00 11:45 am New Concepts in Clinical Trials Various Faculty Members 11:45 am 12:45 pm Lunch 12:45 5:30 pm Group Breakout Sessions DAY 5 TUESDAY, NOVEMBER 10 6:00 7:00 am Continental Breakfast 7:00 am 12:00 noon Proposal Presentations and Discussions 12:00 noon 1:00 pm Wrap-Up and Closing Remarks Kamal F. Itani, MD, FACS Course schedule may be subject to change

4 Faculty Faculty for the course, led by course chair Kamal F. Itani, MD, FACS, includes some of the leading surgeons and bio statisticians with expertise in clinical trials research. Robert J. Anderson, PhD Peter Angelos, MD, PhD, FACS Judy C. Boughey, MBBCh, FACS Jody D. Ciolino, PhD Joseph F. Collins, ScD Lawrence T. Kim, MD, FACS Eric L. Lazar, MD, FACS Peter R. Nelson, MD, MS, FACS Joshua S. Richman, MD, PhD Layton F. Rikkers, MD, FACS George A. Sarosi, Jr., MD, FACS General Information All sessions will be held at the American College of Surgeons headquarters located at 633 N. Saint Clair St., Chicago, IL. Due to the intensity of the program, the course will begin early in the morning each day and no free time is allocated. Attendees are expected to remain until the conclusion of the course in order to receive the maximum CME credit designated for this program. Dress will be business casual and participants are required to bring their own laptop. All course communications will be administered electronically throughout the program, including live updates from faculty and staff. Spouse or guest attendance is not permitted to any of the events. Course Fee The course fee is $2,800. An early bird fee of $2,600 will be applied to attendees who register on or before Friday, September 4, Course fees include tuition, course materials, and meals (daily continental breakfasts, lunches, refreshment breaks, and a group dinner). Participants are responsible for transportation and travel costs, hotel charges, and remaining meals. Course Registration Register online via the course website. Attendance is limited to 50 participants, and preference is given to members of the American College of Surgeons. Notification of acceptance into the course will be ed to non-acs members by Monday, September 28, facs.org/quality-programs/about/cqi/education/clintrial Cancellations and Refunds Refunds will be issued if written requests are received no later than Friday, October 9, A $250 handling fee will be retained for all refunds. Registrants canceling after the October 9 deadline will not receive a refund unless an alternate from the course s wait list is confirmed. Cancellations should be submitted via to registration@facs.org. For registration-related questions, please contact Registration Services at registration@facs.org or For course-related questions, please contact Carla Manosalvas, Division of Research and Optimal Patient Care, at ctmcourse@facs.org or

5 Airfare The ACS has arranged special meeting discounts on United Airlines. These special discounts are available by booking with United Airlines directly, though a travel agent, or online. United Airlines: ACS Z Code: ZTEZ Agreement Code: Purchase your ticket online at united.com and receive a discount off the lowest applicable fares. Please enter ZTEZ to receive your discount when booking online. Housing Information A course housing room block has been reserved at the Hyatt Chicago Magnificent Mile Hotel, located within the ACS headquarters building. A special course rate of $239 per night, plus tax, is available for attendees. Reservation requests will be processed on a first-come, first-served basis and must be received by Friday, October 16, 2015, by 12:00 pm. Requests received after this deadline, or after the room blocks are filled, are subject to rate and space availability. Attendees may reserve rooms by calling or through the group reservation link: ClinicalTrialsCourse2015 Accreditation The American College of Surgeons is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. AMA PRA Category 1 Credits The American College of Surgeons designates this live activity for a maximum of 38 AMA PRA Category 1 Credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity. The course will hold a self assessment component toward Maintenance of Certification (MOC) Part 2. All requirements must be completed to receive AMA PRA Category 1 Credits and hours toward self assessment. Verification of completion of the course will be posted to ACS members My CME Transcript. See you at CTM 2015