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Clinical Trials
EPI 205 Winter 2012 (1.5 units)



OBJECTIVES

The objectives of this course are to provide a detailed understanding of experimental design options; methods of randomization; blinding; developing interventions and controls; measuring outcomes and adverse effects; follow-up; compliance and postrandomization problems.

PREREQUISITES

Designing Clinical Research (Epi 202). Exceptions to this prerequisite may be made with the consent of the Course Director, space permitting.

FACULTY

Course Director:

Deborah Grady, MD, MPH
email: deborah.grady@ucsf.edu
phone: 415-353-9748

Lecturers:

Dennis M. Black, MA, PhD
email: dblack@psg.ucsf.edu
phone: 415-514-8159

 

Steve R. Cummings, MD
email: scummings@sfcc-cpmc.net
phone: 415-600-7401

 

Bernard Lo, MD
email: bernie@medicine.ucsf.edu
phone: 415-476-5370

Section Leaders:

Nisha Acharya, MD, MS
email: nisha.acharya@ucsf.edu

 

Mary Beattie, MD, MAS
email: mary.beattie@ucsfmedctr.org

 

Yoshimi Fukuoka, RN, PhD
email:yoshimi.fukuoka@nursing.ucsf.edu

 

Vanessa Jacoby, MD, MAS
email: jacobyv@obgyn.ucsf.edu

 

John Shepherd, PhD
email: john.shepherd@ucsf.edu

 

Jeff Tice, MD
email: jtice@medicine.ucsf.edu

Teaching Assistant:

Wendy Katzman, PT, DPTSc, OCS
email: clinicaltrials2012@yahoo.com


TEXTBOOKS

Designing Clinical Research by Stephen B Hulley, et al. Lippincott Williams & Wilkins. 3rd Edition. 2007. (library call number R853.C55 D47 2007)

Optional--Do not purchase: Fundamentals of Clinical Trials by Lawrence M. Friedman, Curt D Furberg, David L DeMets. Springer. 4th Edition. 2010.

Textbooks may be purchased from the UCSF online bookstore (as well as Amazon and other vendors).

HOMEWORK

Homework is due by 5 PM on the Monday following the lecture where the homework is assigned. (Note: exceptions are on the two Monday holidays: you can turn in homework on Tuesday, January 17 and February 21.) No late homework will be accepted. Homework assignments will be discussed in the sections.

Protocol Assignment: Email a copy of your cumulative protocol to your section leader by noon the Monday before each section (January 16, February 6 and 27).

FINAL EXAM

There will be a required take home final exam. The exam will be posted on the course website on March 2, 2012 and will be due by 10 AM on Friday, March 16, 2012.

GRADING

Grades will be based on total points achieved on homework (~25%), participation in sections and protocol development and critiquing (~50%), and the final exam (~25%). Late assignments are not accepted.

ENROLLMENT

This course is open to a limited number of individuals outside of the ATCR and Master's programs. Preference is given to UCSF-affiliated personnel. We regret that auditing is not permitted. To apply for this course please fill out and submit the application below. Cost and submission information are in the application.

Application (Word doc, 20KB)