Turning Questions into Trials: Innovation in Surgical Oncology

1. Turning Questions into Trials: Innovation in Surgical Oncology

2. Clinical Trials in Surgical Oncology:Part of BUSM Third-Year Surgery Clerkship Core Lectures • Developed in 2006 to educate third-year medical students during their surgical rotation on clinical trials in surgical oncology • 30-35 medical students participate each rotation • Build a clinical trial in class from a problem that the students see on their surgical clinical rotation • in past, asked for written protocols in advance

3. Clinical Trials in Surgical Oncology Objectives • Educate students about clinical trials in surgical oncology • Familiarize students with core concepts in clinical trials • Encourage students’ active learning when encountering problems in clinical care of patients with cancer • Introduce students to research ideas • Provide students with an opportunity to contemplate their future practice options…academics can be fun! • Assess the efficacy of an active-learning class • Elicit potential ideas for clinical trials!!

4. Material and Issues Covered • What’s the evidence that supports our clinical practice? • What do you not understand in care or what don’t we do well – is it because you don’t know or because WE don’t know? • Titles for trials! And choosing the principal investigator • Inclusion and Exclusion criteria, compassionate use • Politics of trials • Funding for trials • Institutional Review Boards, ethical and safety issues • Trial design: Phase 0-IV, pre-registration, “Journal of Negative Results,” arms, standard of care, crossover, quality of life • Determination of sample size • Bias, randomization , conflict of interest and blinding • Patient perception of risks and benefits and the concept of informed consent • Outcomes and their measurement….

5. Knowledge Assessment /Evaluation: Pre- and post-test comparison (n=194)

6. Clinical Trials in Surgical Oncology: Benefits • Provides an interactive, first-hand perspective into how clinical trials work and where the ideas for clinical trials come from • Enhances communication skills for developing a trial • Humanizes the process of research • Offers medical students the chance to understand the complexity of answering questions and improving care for patients with cancer • Bridges clinical experience, book-based learning and a questioning mind with real-world examples of deficiencies in care (because these are real issues, shows students that these are challenges) • Turn INFORMATION into KNOWLEDGE

7. Examples of misconceptions • Recognize the ways that context influences perception (example: socially accepted practices; patronage and corruption) • Analyze situations to discern degrees of seriousness, potential consequences • Recognize areas and reasons why people may disagree • Engage in active learning early in the course

8. Why I think it works • Based on their personal experience and confusion or dissatisfaction • Immediacy of engagement – requires no a priori knowledge, little preparation other than an engaged and questioning mind • Active elicitation of participation – if you don’t volunteer, you WILL be called upon • Group thinking but individual contribution • People like hearing what others say, and are curious…but also competitive! • Students discover the basic principles of clinical trials – and the basis for clinical practice – through active question and answer

9. Using this innovation • Other clinical rotations • within Introduction to Clinical Medicine (first year course) • Within graduate medical education (residents, fellows) • Introduce social issues or controversial concepts

10. Future modifications… • Introduce social issues or controversial concepts • Longitudinal follow-up • Return to prepared protocols