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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 .

trolled trials is determining whether the sample size is sufficiently large to allow an inference that is applicable in clinical practice. The sample size in a controlled trial cannot be arbitrarily large. The total number of patients potentially available, the budget, and the amount of time available all limit the number

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

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