Turning Questions into Trials:
Innovation in Surgical Oncology
Jennifer E. Rosen MD FACS
Assistant Professor of Surgery and Molecular Medicine
Boston University School of Medicine
Department of Surgery
Instructional Innovation Conference
March 2nd 2012
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
Clinical Trials in Surgical Oncology
Objectives
1. Educate students about clinical trials in surgical oncology
2. Familiarize students with core concepts in clinical trials
3. Encourage students’ active learning when encountering
problems in clinical care of patients with cancer
4. Introduce students to research ideas
5. Provide students with an opportunity to contemplate their
future practice options…academics can be fun!
6. Assess the efficacy of an active-learning class
7. Elicit potential ideas for clinical trials!!
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….
Knowledge Assessment /Evaluation:
Pre- and post-test comparison (n=194)
Pre
correct
Post
correct
P-value
Conclusions?
Question1: A Phase I Clinical Trial is designed to
assess whether a drug will increase overall survival
in patients with cancer.
94.2
99.5
0.002
Already knew this, but still
improved
Question2: An 85 year old woman has a median life
expectancy of one to two more years.
47.6
90
<0.001
Poor knowledge pre lecture,
improved
Question3: Drug companies are required to report
adverse events as they happen in clinical trials to the
FDA
79.1
56.4
<0.001
Did worse with lecture!
Question4: Informed consent is a legal document
admissible in a court of law.
86.9
89.2
0.297
Already knew this, no change
Question5: FDA approval is required in order for a
drug to be used for patient treatment.
69.4
87.4
<0.001
Poor knowledge pre-lecture,
improved
Question6: In order to participate in a clinical trial, a
patient needs to be seen at a center that offers the
trial.
43.4
53.8
0.011
Poor knowledge prelecture,
little change
Question7: What proportion of cancer patients are
enrolled in clinical trials in the United States?
65.1
99.4
<0.001
Fair knowledge prelecture,
improved
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
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
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
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
Future modifications…
• Introduce social issues or controversial
concepts
• Longitudinal follow-up
• Return to prepared protocols