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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.

proaches to calculation of sample size for controlled trials. It then presents a generic formula for sample size that can be specialized to continuous, binary, and time-to-failure vari-ables. The discussion assumes a randomized trial comparing two groups but indicates approaches to more than two groups.

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