10class.wk2 - PubH 7420 Clinical Trials: Readings for Week...

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PubH 7420 Clinical Trials: Readings for Week 2 1. Fundamentals of Clinical Trials , Chapter 5. Supplemental Reading/References 1. Armitage P. The role of randomization in clinical trials. Stat. in Medicine , 1:345-352, 1982. 2. Zelen M. The randomization and stratification of patients to clinical trials. J Chronic Dis , 27:365-375, 1974. 3. Freedman B. Equipiose and the ethics of clinical research. NEJM 317:141-145, 1987. 4. Hill AB. The clinical trial. NEJM 247:113-119. 5. Fisher RA. The Design of Experiments. Edinburgh: Oliver and Boyd, 1955. 6. Chalmers TC. The need for early randomization in the development of new drugs for AIDS. J. of AIDS (Suppl) S10-S15, 1990. 7. Neaton JD, Mugglin AS. From observational studies to randomized trials: asking the right question at the right time. J Clin Periodontol 33:517-519, 2006. 8. Schulz KF, Grimes DA. Unequal group sizes in randomised trials: guarding against guessing. Lancet 359:966-970, 2002. 9. Armitage P. Fisher, Bradford Hill, and randomization. Intl J Epid 2003;32:925- 928. 10. Clinical Trials: A Practical Approach , Chapters 5 and 7. 11. Clinical Trials, Design, Conduct and Analysis , Chapter 10. 1
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A comparative clinical trial is as an experiment to evaluate the relative efficacy and safety of two or more treatments. An essential component of the experimental approach is the use of controls, and in order to ensure that those in the control and experimental groups are similar at the outset, randomization is employed. While there are other approaches to removing the effect of confounding factors and minimizing bias associated with treatment assignment, randomization is considered by most scientists to be the optimal approach when feasible. In most cases, it is feasible. The idea is simple -- compare like with like -- create groups that, at the outset, are homogeneous except for the treatment. First, however, it should be noted that in order to conduct a randomized clinical trial there must be collective uncertainty among clinicians concerning the relative merits of the control and experimental treatment – the timing must be right! Freedman (1987) has characterized this state of uncertainty as equipoise. Chalmers (1990) argued that because equipoise is required to ethically conduct a randomized trial, randomization should be employed before uncontrolled, potentially biased information, concerning the experimental treatment is collected, i.e., randomization should begin with the first patient. Practically, this is not always feasible because information may be lacking on how to correctly use the new treatment (dose, formulation, method of administration). It may also be difficult to obtain funding without preliminary data. Neaton and Mugglin discuss the importance of timing in a recent editorial concerning
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10class.wk2 - PubH 7420 Clinical Trials: Readings for Week...

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