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10class.wk11 - PubH 7420 Clinical Trials: Readings for Week...

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PubH 7420 Clinical Trials: Readings for Week 11 1. Friedman, Furberg, and DeMets. Fundamentals of Clinical Trials , Chapter 15. Supplemental Reading/References 1. Pocock, SJ.: Clinical Trials: A Practical Approach. John Wiley and Sons, Ltd., Chapters 14. 2. DeMets D, Fleming T, et al. The Data and Safety Monitoring Board and Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials. Cont. Clinical Trials , 16:408-421, 1995. 3. Task Force of the Working Group on Arrhythmias of the European Society of Caridiology. The early termination of clinical trials: causes, consequences, and control. Circulation 89:2892-2907, 1994. 4. Meinert C. Clinical tirals and treatment effects monitoring (with comment). Cont. Clinical Trials , 19:515-543, 1998. 5. Guidance for clinical trial sponsors on the establishment and operation of clinical trial data monitoring committees ( www.fda.gov/cber/gdlns/clindatmon.htm ) 6. Ellenberg SS, Fleming TR, DeMets DL. Data monitoring committees in clinical trials. A practical perspective. 7. DeMets D, Califf R, et al. Issues in regulatory guidelines for data monitoring committee. Clinical Trials 1:162-169, 2004. 8. McPherson K. Statistics: the problem of examining accumulating data more than once. NEJM 290:501-502, 1974. 9. Jennison C, Turnbull BW. Group sequential methods with applications to clinical trials. 10. Fleming TR, Neaton JD, et al. Insights from monitoring the CPCRA didanosine/zalciabine trial. JAIDS 10:S9-S18, 1995. 11. DeMets DL, Furberg CD, Friedman LM. Data monitoring in clinical trials. A case studies approach. Springer, 2006. 1
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Considerations for Sequential Monitoring of Clinical Trials with Fixed Sample Sizes for Adverse Effects and Therapeutic Benefit 1. Most clinical trials are designed with a fixed sample size (or expected number of events for morbidity and mortality studies). This is in contrast to sequential designs in which the sample size is not fixed by design but depends on the
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10class.wk11 - PubH 7420 Clinical Trials: Readings for Week...

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