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Non-CME

Pre-Course: Surgical Clinical Trials Primer: Designing Your Study (Non-CME)

Wednesday, March 4, 2026
8:00 AM - 12:30 PM MST
Location:102AB

Randomized controlled trials are the gold standard in evidence-based medicine, but surgical trials present unique challenges. This half-day pre-course explores trial types, trial design and statistical considerations, strategies for success and funding options. Real-world examples of investigator-initiated and industry-sponsored trials highlight successes and lessons from failures.

The course wraps up with a "Continue the Conversation" lunch, offering roundtable discussions with faculty for peer-to-peer learning and Q&A.

Registrants will access a series of four SurgOnc Today podcasts on surgical trial development to prepare ahead of time.

Learning Objectives:

  • Understand the surgical trial development process and weigh different approaches.
  • Begin designing a surgical clinical trial protocol.
  • Identify resources to support trial design and implementation.

Presentations:

  • 8:05 AM - 8:20 AM MST
    Unpacking Clinical Trials: Phase I to Cooperative Studies

    Faculty: Michael C. Lowe, MD, MA – Division of Surgical Oncology, Department of Surgery, Winship Cancer Institute, Emory University

  • 8:20 AM - 8:35 AM MST
    Building Your Trial: Defining Key Clinical Endpoints

    Faculty: Alexandra Gangi, MD – Cedars Sinai Medical Centre

  • 8:35 AM - 8:50 AM MST
    Statistical Essentials: Interim and Final Analysis

    Faculty: Omeed Moaven, MD – Louisiana State University Health Sciences Center

  • 8:50 AM - 9:00 AM MST
    Q&A Session 1
  • 9:00 AM - 9:15 AM MST
    Setting Eligibility Criteria: The Trial Foundation

    Faculty: Mihir M. Shah, MD, MS, FACS, FSSO (he/him/his) – MedStar Washington Hospital Center

  • 9:15 AM - 9:30 AM MST
    Supercharging Trial Recruitment: Proven Strategies

    Faculty: Christina V. Angeles, MD, FACS (she/her/hers) – University of Michigan

  • 9:30 AM - 9:45 AM MST
    Equipping Your Center: Resources for Surgical Trials

    Faculty: Melissa Pilewskie, MD (she/her/hers) – University of Michigan

  • 9:45 AM - 9:55 AM MST
    Q&A Session 2
  • 9:55 AM - 10:15 AM MST
    Break
  • 10:15 AM - 10:30 AM MST
    Funding Your Trial: Phase-Specific Approaches

    Faculty: Philip M. Spanheimer, MD (he/him/his) – University of North Carolina, Department of Surgery

  • 10:30 AM - 10:45 AM MST
    Executing Industry-Sponsored Trials

    Faculty: Guy Travis Clifton, MD – Brooke Army Medical Center- General Surgery Department

  • 10:45 AM - 11:05 AM MST
    Why Trials Fail: Beyond Just Sample Size

    Faculty: Beth A. Helmink, MD, PhD (she/her/hers) – Department of Surgical Oncology, University of Texas MD Anderson Cancer Center

  • 11:05 AM - 11:20 AM MST
    Publishing Post-Trial: Journal, Conferences, and Manuscripts

    Faculty: Syed A. Ahmad, MD (he/him/his) – University of Cincinnati

  • 11:20 AM - 11:30 AM MST
    Q&A Session 3
  • 11:30 AM - 12:00 PM MST
    Keynote: Launching Your Trial: The Power of Mentorship

    Faculty: Andrew M. Lowy, MD – UC San Diego

  • 12:00 PM - 12:30 PM MST
    Boxed Lunch: Networking Meet & Greet