HSEM 3708 Honors Seminar in Clinical Trials - Spring 2009 Proposed Assignments for Group Presentations & Written Summaries [This will be updated frequently ...] Presentations should include discussion of the following: 1. The medical problem 2. Justification for doing the clinical trial; previous studies? 3. Who sponsored the trial? Who authored the paper? 4. Design of the trial 5. Primary and secondary endpoints 6. Duration of the trial (planned and actual) 7. What were the main eligibility requirements? 8. Sample size and number of clinical centers 9. Describe the main statistical analyses 10. Describe the main results 11. If the trial was stopped early, explain why 12. Was this clinical trial important, and why? Did it make a difference in treatment of patients? 13. Are there aspects of this clinical trial that could be criticized? Explain. 14. What did you like best about the presentation of the results? 15. Was there an editorial accompanying the primary publication of this clinical trial's results? What were the major points made in the editorial? 16. Other comments or observations -------------------------------------------------------------- Team #1: Jon Strong, Halyna Ivalschuk, Margaret Dimond, Bora Kutomba Study: "Conjugated Equine Estrogens and Incidence of Probable Dementia and Mild Cognitive Impairment in Postmenopausal Women" by S. A. Shumaker et al. Can be downloaded as a PDF file from the following website: http://jama.ama-assn.org/cgi/content/full/291/24/2947 Presentation date: Monday April 13, 2009 -------------------------------------------------------------- Team #2: Study: The ALL-HAT clinical trial on hypertension Presentation date: Web address for the paper: http://jama.ama-assn.org/cgi/content/full/288/23/2981 See also editorial: http://jama.ama-assn.org/cgi/content/full/288/23/3039 -------------------------------------------------------------- Team #3: Erin Broberg, Sam Tashima, Erin Theisen Study: The NETT trial on lung reduction surgery Presentation date: Wednesday April 1, 2009 Web address for the paper: http://content.nejm.org/cgi/reprint/345/15/1075.pdf?ijkey=e4f07080727ff4145ce553abf0d4324009c07e05 See also editorial: http://content.nejm.org/cgi/content/full/345/15/1126-a -------------------------------------------------------------- Team #4: Kasia Bartczak, Neha Rajagopal, Leigh Scheiner, Brianna Kelm Study: The Concorde Trial (HIV/AIDS: Lancet 334, pages 871-881, 1994) Related article: British Medical Journal 1996; 313:608-610. For Debate: Will We Ever Know When to Treat HIV Infection. A. Phillips, G. Davey Smith, M. Johnson. Web site: http://www.bmj.com/cgi/content/full/313/7057/608 Presentation date: Wednesday, April 8 2009. -------------------------------------------------------------- Team #5: Tope' Daniel, Azra Thakur, Marissa Koran, Erin Brekke Study: Any clinical trial published in NEJM, JAMA, or Lancet, 2000-2009. Presentation date: Monday, April 20, 2009 -------------------------------------------------------------- Team #6: Bora Kutomba, Sarah Gad, Peter Fliss Study: The Coronary Artery Surgery Study (CASS) reference: Circulation, vol. 68, pp 951-960, 1983. Abstract: http://circ.ahajournals.org/cgi/content/abstract/68/5/951 The text of the article (pdf file) can be downloaded from the above website. Presentation Date: April 29, 2009 -------------------------------------------------------------- File name: ~john-c/HSEM3010.group.assignments Date of last revision: April 13, 2009