SAMPLE-SIZE REQUIREMENTS FOR EVALUATING A CONSERVATIVE THERAPY

  • 1 January 1978
    • journal article
    • research article
    • Vol. 62  (7) , 1037-1040
Abstract
Determination of adequate sample size for a clinical trial has traditionally involved the specification of type I (false positive) and type II (false negative) error rates, and a difference that one wishes to detect. Because newer therapy is more invasive or more toxic, it is conventional for the type I error to be 0.05 so that new therapy is not accepted as superior unless its advantages are definitively established. Many new trials were directed toward showing that more conservative treatment is equivalent in efficacy to standard intensive therapy. Formulas which prescribe the sample size necessary to meet certain criteria specified by the investigator for this alternative type of clinical trial were provided. The percent increase in total sample size is described when more cancer patients are allocated to 1 treatment than the other.

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