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September 2022

Non-randomized controls in cancer clinical trials

Author(s): Freireich, E.

Journal/Book: The New England Journal of Medicine. 1974; 290: 198-203.

Abstract: Quantitative, comparative clinical trials can sometimes be better accomplished with technics other than randomization for selection of a control group. These include selection of literature controls, matched controls and controls from a previous study. Such controls have permitted detection of therapeutic activity for many anti-cancer agents. Circumstances of greatest utility are as follows: when the primary purpose of study is to estimate effectiveness of treatment;. when large differences in response rate are expiated on the basis of preliminary studies; or when the new therapy would only be interesting if it was substantially more effective than the standard.When a new therapy is to be evaluated, clinical investigators must consider both ethical responsibility to administer best available therapy and scientific responsibility to conduct a proper evaluation. Selected control patients can permit valid evaluation of a new therapy without the requirement of prescribing control therapy known to be ineffective.

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