HSEM 3708: Honors Seminar in Clinical Trials

Spring, 2009

Syllabus

This course is comprised primarily of a collection of examples of

clinical trials. The underlying principles of study design, randomization,

endpoint definition and determination, methods for data analysis,

sample size and statistical power determination will be discussed in

relation to specific clinical trials. Development of protocols, forms

design, data management, and reporting will also be discussed.

Additional topics will include the effects of clinical trials on medical

practice, ethics and ethical violations, and the costs and politics of

clinical trials.

Specific Clinical Trials and Topics:

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1. A Trial of Dexamethasone vs. Placebo for Cerebral Malaria (class handout; NEJM, 1982)

2. A Trial of Acupuncture for Peripheral Neuropathy in HIV/AIDS (class handout)

3. The Women’s Health Study: Hormone Replacement Trial

4. Studies of Beta Carotene to Prevent Lung Cancer: CARET, ATBC, others

5. The Breast Cancer Adjuvant Studies: Lumpectomy and Ethics (Class handouts; NEJM, 1985, 1994)

6. TGN1412: A Phase I Disaster (Class handouts)

7. The SMART Study: Refining treatment of HIV (NEJM, November 2006)

8. A Trial of Prayer

9. ACTG 19: Zidovudine for HIV/AIDS

10. The CAST Study: Antiarrhythmic drugs and Sudden Death (Deadly Medicine, by Thomas Moore)

11. Nonrandomized trials: Laetrile [Moertel, Mayo Clinic], Starvation [Keys, U. of Minnesota]

12. A comparison of 4 weight-loss diets [March 2007, JAMA]

13. The ALL-HAT clinical trial: hypertension (JAMA 288: 2981-2997, 2002)

14. The Intermittent positive pressure breathing trial (Ann. Int. Med 99, 612-620, 1983).

15. The NETT trial on lung reduction surgery (NEJM 348: 2059-2073, 2003).

16. The Concorde Trial (HIV/AIDS; Lancet 334: 871-881, 1994)

17. ACTG Protocol 019 (zidovudine for HIV/AIDS; JAMA 272: 437-442, 1994).

18. Urokinase pulmonary embolism trial (JAMA 214: 2163-2172, 1970)

19. Other clinical trials from either NEJM, JAMA, or Lancet in the years 2006-2007 (for

class projects), chosen by the project team.

Statistical Topics:

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1. Quantitative outcomes: z-tests and t-tests

2. 2 x 2 tables: comparing proportions

3. Randomization

4. Life tables, survival curves, Kaplan-Meier statistics

5. Data quality, missing data

6. Early termination; sequential analysis

Issues and Controversies

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1. Protection of Human Subjects, IRBs, Confidentiality, HIPAA

2. Informed Consent

3. Data and Safety Monitoring

4. Ethical controversies

5. The Role of the FDA; Politics

6. Costs

7. The Effects of Clinical Trials on Practice

· Web address of this page: HSEM.3010.syllabus.s2007.html

· Main Page: http://www.biostat.umn.edu/~john-c/HSEM3010.s2007.html

Most recent update: January 25, 2009