· Home  · Overall Schedule   · Courses  · Programs  · Rosters  · Career Awards

OBJECTIVES

This course will provide a survey of drug and device development from late preclinical through phase 3 clinical studies. Through lectures and case studies, it will introduce students to drug/device regulations, investigational new drug filings, assessment of drug candidates, statistics, safety monitoring, clinical study design and conduct.

At the end of the course, students will be able to:
1. Describe pertinent FDA and EMEA regulations regarding clinical studies and drug/device approvals;
2. Discuss the basis for FDA and EMEA regulations;
3. Define patents and intellectual property issues surrounding development of drugs and devices;
4. Apply principles of signal detection to assess safety signals;
5. Evaluate, at a high level, drug candidates for suitability for further development;
6. Identify key study design principles;
7. Describe some of the typical clinical study designs and rationale for them; and
8. Synthesize, at a high level, a drug or device development pathway.

PREREQUISITES

None.

FACULTY

FORMAT

Lectures: Wednesdays, 10:30 AM to 12 PM, March 28 through May 30.

TEXTBOOK

Principles and Practice of Clinical Trial Medicine by Richard Chin and Bruce Y Lee. Academic Press. 1st Edition. 2008.

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

GRADING

50% of the grade will be based on the case study assignment and 50% on the homework assignments.

Homework assignments are due the week following the week they are assigned. The case study assignment is due May 30.

How to turn in your homework assignment:
Give your printed assignment to Brenda during class.
How will graded homework assignments be returned?
Graded assignments will be available during class, or in Brenda's mail box slot in the Department of Epidemiology and Biostatistics Offices, 5th Floor, Suite 5700. Hours: Monday-Friday 8AM-5PM.

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.

Note: CTSI tuition scholarships are available for UCSF Graduate Students pursuing a PhD degree in one of the laboratory-based basic science programs and UCSF post-doctoral (PhD) fellows working in a basic science laboratory.

Application (Word doc, 20KB)