Clinical Trials
Winter 2024 (2 units)
This course is designed to introduce students to the fundamentals of clinical trial design and methods, including strategies for selecting trial participants and allocating them to interventions; designing and administering both experimental and comparator interventions; implementing and maintaining blinding to intervention assignment; defining primary and secondary trial outcomes; measuring outcomes and adverse events; addressing ethical issues that arise in trials; monitoring trial participants and managing post-randomization problems; and performing interim data and safety monitoring in trials.
Objectives
By the end of this course, students should be able to:
- Describe the value of randomization and blinding in clinical trials
- Consider the strengths and shortcomings of different intervention comparators or controls
- Outline appropriate plans for measuring outcomes and adverse effects in trials
- Describe strategies for monitoring participants after initiation of interventions
- Rrecognize common trial compliance and post-randomization problems
- Describe common statistical issues in clinical trials
- Navigate important ethical issues and interim monitoring strategies in trials
Prerequisites
Designing Clinical Research Successful completion of the UCSF Designing Clinical Research course (Epi 202 or 150.03) or equivalent past training, and ability to set aside 6 hours per week for course activities. Exceptions to these prerequisites may be made with the consent of the Course Director, space permitting.
Faculty
| Course Co-Directors: |
Professor, Department of Medicine |
|
Patrick Phillips, PhD, MS, MA Associate Professor, Department of Medicine |
Format
Course content will be delivered through a combination of video lectures, large group workshops, and small group discussions:
- Large Group Discussions: Thursdays: 8:45 AM to 10:15 AM, Jan. 11 to Mar. 21. 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.
- Video Lectures: Pre-recorded video lectures will be uploaded to the CLE website every week, usually by Monday before 12:00pm (noon); if the Monday falls on a holiday, the lecture will be uploaded by noon on Tuesday. Students should plan on watching each week’s lecture by the Thursday of the same week.
- Workshops: Each week, an instructor will lead an interactive workshop designed to deepen students’ understanding of course concepts and provide an opportunity for students to ask questions. Workshops will be held in person in Mission Hall Room MH-2103 on Thursdays, 9:00-10:15am. Although slides from workshops will be posted on-line, participation is in-person only.
- Small Groups: Small group discussion sections will focus on discussion of and feedback on students’ draft clinical trial protocols. Sections will be held primarily in person at Mission Hall from 3:15–5:00 pm on four Tuesdays during the course: January 30, February 13, February 27, and March 12.
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.
Lecture-related homework assignments are due by 12:00 noon on the Monday following the lecture where the homework is assigned. If the Monday is a holiday (such as MLK Day or Presidents Day), homework will be due by 12:00 noon on Tuesday of the same week.
Protocol Assignment: Email a copy of your cumulative protocol to your section leader by noon the Monday before each Small Group Section. If the Monday is a holiday, protocol assignments are due on Tuesday of the same week.
Students not in full-year TICR Programs who satisfactorily pass all course requirements will, upon request, receive a Certificate of Course Completion.
Only UCSF students (defined as individuals enrolled in UCSF degree or certificate programs) will receive academic credit for courses. Official transcripts are available to UCSF students only. A Certificate of Course Completion will be available upon request to individuals who are not UCSF students and satisfactorily pass all course requirements.
To Enroll
ATCR and MAS students use the Student Portal
Students taking individual courses:
Course Fees
How to pay (please read before applying)
Winter 2024 Course Schedule
Apply by January 15, 2024 (deadline extended)