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Sample Size Calculations for Randomized Controlled Trials

Sample size Calculations for Randomized Controlled TrialsJanet WittesINTRODUCTIONMost informed consent documents for Randomized con-trolled Trials implicitly or explicitly promise the prospectiveparticipant that the trial has a reasonable chance of answer-ing a medically important question. The medical literature,however, is replete with descriptions of Trials that providedequivocal answers to the questions they addressed. Papersdescribing the results of such studies may clearly imply that thetrial required a much larger Sample size to adequately addressthe questions it posed. Hidden in file drawers, undoubtedly, aredata from other Trials whose results never saw the light ofday some, perhaps, victims of inadequate Sample size . Al-though many inadequate-sized studies are performed in a sin-gle institution with patients who happen to be available, someare multicenter Trials designed with overly optimistic assump-tions about the effectiveness of therapy, too high an estimate ofthe event rate in the control group, or unrealistic assumptionsabout follow-up and this review, I discuss statistical considerations in thechoice of s

calculating sample size, one would use a standard formula for time to failure and select as the candidate sample size the larger of the sizes required to achieve the desired power— for example, 80 percent—for each of the two endpoints. Suppose that sample size is 1,500 per group for hospital-ization and 2,500 for mortality. Having ...

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  Samples, Size, Trail, Calculation, Controlled, Randomized, Sample size, Sample size calculations for randomized controlled trials

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