10class.wk7 - PubH 7420 Clinical Trials: Readings for Week...

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PubH 7420 Clinical Trials: Readings for Week 7 1. Freidman, Furberg, and DeMets, Fundamentals of Clinical Trials . Chapters 3 and 10. Supplemental Reading/References 1. Pocock SJ, Clinical Trials: A Practical Approach. John Wiley and Sons, Ltd. Chapter 3. 2. Clinical Trials. Design, Conduct and Analysis . Chapters 5 and 16. 3. Yusef S, Held P, Tea K et al. Selection of patients for randomized controlled trials: Implications of wide or narrow eligibility criteria. Stat Med 9:73-86, 1990. 4. Pablos-Mendez A, Barr RG, Shea S. Run-in periods in randomized trials. Implications for the application of results in clinical practice. JAMA 279:222- 225,1998. 5. Davis CE et al. A single cholesterol measurement underestimates the risk of coronary heart disease. JAMA 264:3044-3046, 1991. 6. Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 360:1903-1913, 2002. 7. Gardner MJ, Heady JA. Some effects of within-person variability in epidemiologic studies. J Chron Dis , 26, 781-795, 1973. 8. Ederer F. Serum cholesterol changes: effects of diet and regression toward the mean. J. Chron Dis 25:277-289, 1972. 9. Davis CE. The effect of regression to the mean in epidemiologic and clinical studies. Amer J Epid 104:493-498, 1976. 10. Yudkin PL, Stratton IM. How to deal with regression to the mean in intervention studies. Lancet 347:241-243, 1996. 11. Clarke R, Shipley M, Lewington S., et al. Under-estimation of risk associations due to regression dilution in long-term follow-up of prospective studies. Amer J Epid 150:341-353, 1999. 1
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Eligibility Criteria for Clinical Trials Prior to randomization in a clinical trial patients must meet pre-specified eligibility criteria. These criteria, which are stated in advance of the trial, are frequently referred to as inclusion and exclusion criteria. An example of an inclusion criterion would be the signing of the consent form. An example of an exclusion criterion would be a contraindication to one of the treatments being studied. The study population (those randomized), as defined by the eligibility criteria, can be thought of as a subset of the larger target population to which we wish to generalize the findings of our study. In many trials eligibility criteria are specified so as to identify a group of "homogeneous" patients. This allows the question to be stated more precisely and may permit the question to be addressed with a smaller sample size because variability among subjects is reduced. The disadvantage of this approach is that the results of the study may not be as widely generalizable and some patients may eventually be given treatments for which little is known from controlled studies, e.g., lipid lowering drugs in women and the elderly, antiretroviral drugs in women and non-whites or in persons with very early disease. If a heterogeneous group is not enrolled, the consistency of the
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10class.wk7 - PubH 7420 Clinical Trials: Readings for Week...

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