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Designing Clinical Research for Residents and Students
EPI 150.03 Summer 2008 (2 units)
Course Directors: Thomas Novotny, MD MPH
Professor in Residence, Epidemiology and Biostatistics
Kirsten Bibbins-Domingo, PhD MD
Assistant Professor, Medicine and Epidemiology and Biostatistics
Douglas Bauer, MD
Professor, General Internal Medicine and
Epidemiology and Biostatistics
| OVERVIEW |
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This course guides research scholars through the essential
components for writing a clinical research protocol, developed around
their own clinical research question. The students will attend bi-weekly
group lectures and small seminar groups for four weeks as well as a peer
review session in the last week of the course. The course will cover study
questions, hypotheses, specific aims, study types, sample size estimation,
power calculations, and data analysis. Small groups will be developed
separately for pre-doctoral students and clinical trainees (residents).
Please follow instructions for enrollment below.
| OBJECTIVES |
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1. Participants will understand study design, data analysis
and management, sample size calculations, and power calculations.
2. Participants will understand the inferences that may be drawn from
findings of clinical research studies.
3. Participants will draft a five-page clinical research protocol for
use in their proposed research projects.
4. Participants will provide peer review and be able to helpfully critique
their co-learners' protocols.
| PREREQUISITES |
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Must be a dental, medical, nursing, or pharmacy student, or be serving
as a postgraduate clinical trainee, e.g., Resident.
Must have consent of instructor and training program supervisor.
Must provide a Research Question they will work on and the name
of a mentor with whom they will work.
| FACULTY & STAFF |
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| Course Director: |
Tom Novotny, MD, MPH
email: novotnyt@globalhealth.ucsf.edu
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| Co-Director: |
Kirsten Bibbins-Domingo, PhD, MD
email:bibbinsk@medicine.ucsf.edu
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| Co-Director: |
Douglas Bauer, MD
email: dbauer@psg.ucsf.edu
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| Lecturers: |
Steve Hulley, MD MPH
email: shulley@psg.ucsf.edu
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Michael Kohn, MD MPP
email: makohn@pacbell.net
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Chuck McCulloch, PhD
email: chuck@biostat.ucsf.edu
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Celia Kaplan, DPH
email: celia.kaplan@ucsf.edu
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Deborah Grady, MD MPH
email: deborah.grady@ucsf.edu
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| Teaching Assistants: |
Andy Choi, MD MAS
email: Andy.Choi@va.gov
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Yeuen Kim, MD MAS
email: Yeuen.Kim@ucsf.edu
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Jean Tang, MD PhD
email: tangjy@derm.ucsf.edu
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Emily Wang, MD
email: emily.wang@ucsf.edu
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FORMAT
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Lectures: 9-10:15 AM on August 4, 6, 11, 13, 18, 20, 25, 27 and
final peer review session required on Friday, August 29.
Small Groups: 10:30-Noon, following the lectures each day.
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TEXTBOOK
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Designing Clinical Research
by S. Hulley et al. Lippincott Williams & Wilkins. 3rd Edition. 2006.
Take NIH Certification on-line for Human Subject Protections:
Basic Course https://www.researchonline.ucsf.edu/
| GRADING |
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Students are expected to attend all classes and small groups
with only ONE excused absence permitted. Participation in small groups,
completion of reading assignments and problems on a daily basis, and final
submission of completed protocol are minimum requirements for a passing
grade (Honors-Pass-Fail option only).
| ASSIGNMENTS |
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See syllabus for reading assignments.
| ENROLLMENT |
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PLEASE APPLY EARLY AS SPACE IS LIMITED. APPLICATIONS FOR
SUMMER 2008 ARE DUE BY JULY 11, 2008.
Note to Residents: Epi 150.03 is offered free
of charge for UCSF residents. Support for residents is provided by the
Clinical and Translational Science Training (CTST) Resident Research Program.
When you submit the payment form for this course please indicate on the
form "tuition covered by CTST".
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