10class.wk5 - PubH 7420 Clinical Trials: Readings for Week...

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Unformatted text preview: PubH 7420 Clinical Trials: Readings for Week 5 1. Friedman, Furberg, and DeMets. Fundamentals of Clinical Trials, Chapters 2 and 6. Supplemental Reading/References 1. Schulz KF, Grimes DA. Blinding in randomized trials: hiding who got what. Lancet 359:696-700, 2002. 2. Boutron I, Estellat C, Guittet L, et al. Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review: PLoS Medicine 10;e425, 2006. 3. Beecher HK. The Powerful Placebo, J.A.M.A. , 159, 1602-1606, 1955. 4. Pocock SJ: Clinical Trials. A practical approach. John Wiley and Sons, Ltd. Chapter 3, pages 38-49, Chapter 6. 5. Clinical Trials: Design, Conduct and Analysis, Chapter 8. 6. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J. Chron Dis ; 20:637-648, 1967. 7. Citron ML. Placebos and principles: a trial of Ondensetron Annals of Int Med ; 118:470-471, 1993. 8. Rothman KJ, Michels KB. The continuing unethical use of placebo controls. NEJM ; 331:394-398, 1994. 9. Taubes G. Use of placebo controls in clinical trials disputed. Science ; 267:25- 26, 1995. 10. Enserink M. Can the placebo be the cure? Science 284:238-240, 1999. 11. Temple R, Ellenberg SS. Placebo-controlled trials and active-controlled trials in the evaluation of new treatments. Part 1: Ethical and scientific issues. Ann Int Med 133:455-463, 2000. 12. Ellenberg SS, Temple R. Placebo-controlled trials and active-controlled trials in the evaluation of new treatments. Part 2: Practical issues and specific cases. Ann Int Med 133:455-463, 2000. 13. Neaton JD, Wentworth DN, et al. Considerations in choice of a clinical endpoint for AIDS clinical trials. Stat Med 13;2107-2125, 1994. 1 14. Neaton JD, Gray G, Zuckerman BD, Konstam MA. Key issues in endpoint selection for heart failure trials: composite endpoints. J Card Fail 11:567-575, 2005. 15. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Annals of Int Med ; 125; 605-613, 1996. 16. Psaty BM, Weiss NS. NSAID trials and the choice of comparators questions of public health importance. NEJM 356:328-330, 2007. 17. Byar DM. Design considerations for AIDS trial. J Acquire Immune Defic Syndr 2 (suppl):S16-S19, 1990. 18. Olschewski M, Schumacher M, Davis KB. Analysis of randomized and non- randomized patients in clinical trials using the comprehensive cohort-follow-up study design. Cont Clin Trials 13:226-239, 1992. 2 BLINDING OR MASKING First, consider some definitions. 1. Bias- a systematic error which results in a difference between the "true" value and the value actually obtained (as opposed to sampling variability in which the error is assumed random). In clinical trials, this error can result from a preconceived, sometimes unconscious preference, on the part of the patient or investigator which influences the way in which a treatment is evaluated. This bias may manifest itself in the way a response variable is measured, how data is analyzed or how the results of a trial are reported.analyzed or how the results of a trial are reported....
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This note was uploaded on 11/21/2011 for the course PUBH 7420 taught by Professor Ph7420 during the Spring '07 term at Minnesota.

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10class.wk5 - PubH 7420 Clinical Trials: Readings for Week...

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