CLA Honors Seminar in Clinical Trials - Spring 2009- 2 cr.
School of Public Health
Division of Biostatistics
Honors Seminar in Clinical Trials - Spring, 2009
– 2 Cr.
Title: Introduction to Randomized Clinical Trials
Instructor: Connett, John E., Division of Biostatistics, School of Public Health.
Office: A-464 Mayo. Office hours: by appointment.
Teaching Assistant: Zabor, Emily, Division of Biostatistics, School of Public Health.
Office hours: A-446 Mayo, Tuesdays 4:30-5:30, Wednesdays 1:30-2:30 and by appointment.
Phone: 624-2957. E-mail: zabor008@umn.edu
Description:
A clinical
trial is an experiment carried out in human beings. Randomized clinical trials are the principal method used to test whether new
drugs, surgical methods, or other treatments are effective in curing or
preventing disease. Clinical trials
require the cooperative efforts of researchers in medicine, epidemiology,
pharmacology, biostatistics, data management, ethics, and behavioral sciences - plus, typically,
lots of money and sometimes politics.
They have enormous influence on the modern practice of medicine. This course will provide an introduction to
clinical trials through a series of historical examples: clinical trials in
polio prevention, breast cancer, HIV/AIDS, heart disease, lung disease,
diabetes, eye disease, acupuncture, and other areas. The emphasis here will be on:
·
Statistical
issues: design and data analysis; choice of endpoints, survival analysis,
testing and estimation; intention-to-treat principle; metaanalyses.
·
Ethical issues:
potential harm to patients vs. advancement of medicine; costs and benefits and
conflicts of interest; data falsification and its consequences
·
Medical issues:
how clinical trials affect the practice of medicine (or don’t)
·
Regulatory
issues: the role of the FDA and its track record
One goal of the course is to provide a
rigorous but relatively painless introduction to the statistical methods used
in clinical trials.
Target audience: Pre-med or pre-nursing and other health-related fields, biology, statistics and math majors. Pre-requisites: at least a semester of college algebra.
Course Materials:
·
Lecture notes
(available on the course website)
·
Readings: Deadly Medicine, by Thomas Moore;
articles from the New England Journal of
Medicine, the Journal of the American
Medical Association, Lancet, Science, and other journals
Class Time: 70-75% lecture, 25-30% discussion
Work Load:
Grade:
25% homework, 25% midterm exam, 20% written project,
30% final exam; exam format, problems and essay questions
Most recent update: January 20, 2009.