Clinical Trials

EPI 205 Winter 2021 (1.5 units)
Course Director: Dennis Black, MA, PhD
Professor
Department of Epidemiology & Biostatistics

OBJECTIVES

The objectives of this course are to provide a detailed understanding of experimental study design options; methods of randomization; blinding; developing interventions and comparators; 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:

Dennis Black, MA, PhD
Phone: 415-514-8159
email: dennis.black@ucsf.edu

Lecturers: Deborah Grady, MD, MPH
email: deborah.Grady@ucsf.edu
 

Alison Huang, MD
email: alison.huang@ucsf.edu

Section Leaders: Andy Avins, MD, MPH
email: andy.l.avins@kp.org
  Trisha Hue, PhD
email: trisha.hue@ucsf.edu
  Alice Pressman, PhD
email: pressmAR@sutterhealth.org
  Patrick Phillips, PhD, MS, MA
email: Patrick.Phillips@ucsf.edu
  Willa Brenowitz, PhD
email: Willa.Brenowitz@ucsf.edu
  Meghana Gadgil, MD
email: Meghana.Gadgil@ucsf.edu
  Veronica Yank, MD
email: Veronica.Yank@ucsf.edu
Teaching Assistants: Laura Koth, MD
email: UCSFClinicalTrials2021@gmail.com
  Paul Krezanoski, MD
email: UCSFClinicalTrials2021@gmail.com
FORMAT

Course content will be delivered through large group discussions and small group discussions.

  1. Large Group Discussions:
    Thursdays: 8:45 AM to 10:15 AM, Jan. 7 to Mar. 17. 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 Discussions:
    Content: Overview and discussion of lectures, and review of assignments.
    Time: Tuesday: 3:15 PM to 5:00 PM, Jan 26, Feb 9, 23 (Mar 9)

The daily schedule of activities will be posted on the course's online syllabus.

MATERIALS

Designing Clinical Research by Stephen B. Hulley, et al. Lippincott Williams & Wilkins. 4th Edition. 2013.

Optional:

Fundamentals of Clinical Trials by Lawrence M. Friedman et al. Springer. 4th Edition. 2010. Available for downloading from UCSF library.

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

GRADING

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

Homework is due by 5 PM on the Monday following the lecture when the homework is assigned. Homework assignments will be discussed in the Small Group Sections.

Protocol Assignment: Email a copy of your cumulative protocol to your section leader by noon the Monday before each Small Group Section.

Students not in full-year TICR Programs who satisfactorily pass all course requirements will, upon request, receive a Certificate of Course Completion.

UCSF Graduate Division Policy on Disabilities

TO ENROLL

This course is sponsored by the Training in Clinical Research (TICR) Program, and space is limited. Preference is given to UCSF-affiliated personnel. We regret that auditing in the classroom is not permitted, but most of the course materials (with the exception of videotapes, answer keys, examinations, and copyrighted documents) are freely available (without formal enrollment) on the course’s online syllabus. Many students can glean the majority of the course’s content from this free access, but, importantly, formal enrollment also provides access to faculty for questions and individual-level extension of the curriculum, a community of other engaged students for in-person real-time discussion, and personalized correction and feedback on homework and projects.

To enroll in this course, please fill out and submit the application below. Please see our fees page for cost information. The deadline for application is December 21, 2021. Only one application needs to be completed for all courses desired during the quarter.

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APPLICATION Information for how to pay;
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