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Designing Clinical Research
EPI 202 Summer 2012 (2 units)





An online version of this course will be available to a limited number of students on a first come, first served basis. Please note the online small group session will be held on Wednesdays at 9:00 to 11:00 am (Pacific Time).

OBJECTIVES

The objectives for this course are for participants to:

  • acquire skills for designing and interpreting clinical research;
  • produce a complete clinical research protocol, including background, sampling, measurements, and data analysis;
  • help others in the class to develop these skills and protocols; and
  • have, over the years, a multiplier effect by teaching these skills to others.
PREREQUISITES
  • Possession of a graduate or professional doctoral degree (MD, PhD, DDS, PharmD or international equivalent) or currently enrolled in a doctoral program. Exceptions to these prerequisites may be made with the consent of the Course Director, space permitting. Undergraduate and professional students, as well as clinical residents are invited to take Designing Clinical Research for Residents and Students (Epi 150.03).
  • Proficiency with word processing software, biomedical literature searching with Pubmed, and reference management software (Endnote, RefWorks or other software).
FACULTY & STAFF

Course Director:

Tom Newman, MD, MPH
Phone: 415-514-8007
Professor of Epidemiology & Biostatistics and Pediatrics
email: newman@epi.ucsf.edu

Lecturers: Warren Browner, MD, MPH
Professor of Epidemiology and Biostatistics and Medicine; CEO, California Pacific Medical Center
  Steve Cummings, MD
Professor Emeritus of Medicine and Epidemiology & Biostatistics
  Alan Go, MD
Senior Physician and Research Scientist, Kaiser; Associate Professor of Epidemiology & Biostatistics
  Deborah Grady, MD, MPH
Professor of Medicine and Epidemiology & Biostatistics
  Charles McCulloch, PhD Professor of Epidemiology & Biostatistics
Section Leaders:

Naomi Bardach, MD
bardachn@peds.ucsf.edu

  Hal Barron, MD
barron.hal@gene.com
  Michael Cabana, MD, MPH
CabanaM@peds.ucsf.edu
  Hillary Copp, MD, MS
copphl@urology.ucsf.edu
  Bruce Gaynor, MD
Bruce.Gaynor@ucsf.edu
  Hannah Glass, MD
hannah.glass@ucsf.edu
 

Mary Haan, Phd
mary.haan@ucsf.edu

  Carlos Iribarren, MD, MPH, PhD
cgi@dor.kaiser.org
  Anthony Kim, MD
akim@ucsf.edu
  Conan MacDougall, PharmD
macdougallc@pharmacy.ucsf.edu
  Joel Simon, MD, MPH
joel.simon@ucsf.edu
  John Takayama, MD, MPH
takayamaj@peds.ucsf.edu
  Jess Waldura, MD
walduraj@nccc.ucsf.edu
  Janet Wojcicki, MD, MPH
wojcickij@peds.ucsf.edu
Course Coordinator:

Olivia DeLeon
email: olivia@epi.ucsf.edu
phone: 415-514-8231
fax: 415-514-8150
mail stop: Box 0560


FORMAT

Both an in-person and online version of the course are offered. The online version will feature the exact materials as the in-person version, with content being delivered through online recordings of the weekly lectures as well as online web conferencing for small group discussion sections. The online version also features the same access to course faculty for discussion and questions as the in-person version.

  1. Lectures: Tuesdays: 9:10 to 10:00 am, July 31 through Sept. 11.
    Lecture recordings will be available
    online later in the day. To determine if you have sufficient bandwith to view online lectures, please visit our demonstration site.

  2. Small Group Sections:
    Content: Review of assigned protocol components and discussion of readings and exercises.
    A. In-person Small Group Sections: Tuesdays: 10:10 am to Noon, July 31 through Sept. 11.
    B. Online: Wednesdays at 9:00 am to 11:00 am (Pacific Time). Note: a high-speed internet connection is required.

  3. Protocol Review: Protocols due (via e-mail) by 5:00 pm: Sept. 18. Student pairs or trios meet with a member of the faculty on Oct 2 and 9 (generally 8:15-9:45; other times may be possible).

All course materials and handouts will be posted on the course's online syllabus.

TEXTBOOK

Required Reading: Designing Clinical Research by Stephen B. Hulley, MD, MPH et al. Lippincott Williams & Wilkins. 3rd Edition. 2007. UCSF library call number: R853.C55 D47.

Recommended Reading: Evidence-Based Diagnosis by Thomas B. Newman and Michael A. Kohn. Cambridge University Press. 1st Edition. 2009. UCSF library call number: RC71.3.N49 2009.

Books may be purchased either through the publisher or a variety of commercial venues (e.g., Amazon.com).

GRADING

For those taking the course for credit, grades will be based on assignments and participation in sections (60%) and on the 5-page protocol (40%). If you think you might miss more than one class we recommend you do not take the course for a letter grade.

Students who satisfactorily pass all course requirements will receive a Certificate of Course Completion.

ASSIGNMENTS

Weeks 1-7

  • Read Designing Clinical Research (Third Edition).
  • Do the exercises
  • Compose parts of your protocol (specific assignments in the syllabus section)
  • Bring the first draft of your homework (on paper) to section. Then you can make some revisions and e-mail it to your section leader by MIDNIGHT WEDNESDAY

Week 8

  • Finish your protocol and submit by email.

Week 11 or 12

  • Critique one another’s protocols in groups of 2 or 3 with a new faculty member (if you are NOT in the ATCR or Master's program). Students in the ATCR and Master's programs review their protocols during Fall Work In Progress seminars.
ENROLLMENT

APPLICATION

For scholars taking the online version: Partial scholarships may be available, upon justification, to scholars residing in countries with low income or lower middle income economies as defined by the World Bank. If you believe you are eligible for a scholarship, please send a justification of less than one page to Olivia DeLeon at olivia@epi.ucsf.edu. In the justification, include the country in which you reside, your current income, and your access, if any, to educational funds from local institutions. Please also send your curriculum vitae (CV). Note that the scholarship does not include cost of textbook, any software, or any local costs associated with accessing a high-speed internet connection.