Clinical Trials

Winter 2023 (2 units)

Instruction in experimental study design options; methods of randomization; blinding, interventions and controls; measuring outcomes and adverse effects; follow-up, compliance and postrandomization problems; ethical issues; and working with pharmaceutical companies.

Objectives

The objectives for this course are for participants 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; and
  • 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 Co-Director:

Dennis Black, MA, PhD

Professor, Department of Epidemiology and Biostatistics
email: [email protected]

Course Co-Director

Alison Huang, MD, MAS

Professor, Department of Medicine
email: [email protected]

 

AFormat

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. 12 to Mar. 23. 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 31, Feb 21, March 7, 21

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

Materials

Designing Clinical Research by Warren Browner, MD, MPH, et al. Wolters Kluwer. 5th Edition. 2022. UCSF library call number: R853.C55 D47.

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

ATCR and MAS students use the Student Portal

Students taking individual courses:

Course Fees
How to pay (please read before applying)
Winter Course Schedule (available Oct 1)


 

Apply (application for Winter will be available November 15, 2022)