School of Public Health
1. What is meant by the phrase 'intent to treat'? Why is it an important principle in clinical trials?
2. What is meant by 'surrogate endpoints' ? Explain the significance of this phrase in clinical trials.
3. Describe what is meant by Phase I, Phase II, and Phase III studies.
4. Why are clinical trials regarded as more reliable than case-control studies?
5. What are the key ingredients in estimating sample size for a clinical trial?
6. An investigator decides that randomization of patients is a nuisance. He decides to simply assign patients who appear on Monday, Wednesday and Friday to Drug A and those who appear on Tuesday, Thursday, and Saturday to Drug B. (No one appears on Sunday.) What might be wrong with such a scheme?
7. List 5 essential ingredients in an informed-consent document.
8. What are the stages in development of a new drug?
9. In your view, what mistakes (if any) were made in the testing of TGN1412 ?
10. What is a p-value?
11. What is statistical power?
12. An investigator wants to study the effects of a certain kind of eyedrops. The primary endpoint of the study is the change in the pressure within the eye (intraocular pressure). The investigator plans to randomize one eye of each participant to either the drug or a placebo, and the other eye will get the opposite. Is this a good design? Or might it be better to randomize each participant to get either the drug in both eyes or the placebo in both eyes? What are advantages and disadvantages of each of these two designs?
13. What was the importance of the main result of the ALL-HAT study?
14. What was the importance of the main result of the SMART study?
15. Why do you think some members of the Monitoring Board of the SMART study did not favor stopping the clinical trial at the time it was stopped?
16. Do you think the FDA is influenced by financial pressures? Other pressures? Describe.
17. Speculate on why Roger Poisson falsified eligibility data for the Breast Cancer Adjuvant Study.
18. How would you design a clinical trial of a new vaccine to prevent avian flu? What are the ethical considerations?
[More to be added ...]
Web address of this page: http://www.biostat.umn.edu/~john-c/HSEM3010.s2007.html
Most recent update: April 26, 2007.