Interim analyses in clinical trials.
Clinical trials of new cancer treatments often involve multiple analyses of the data to address concerns related to medical ethics and the costs and efficiency of medical research. Failure to account for such interim analyses can introduce significant bias into the results of a study. The authors discuss the role of interim analyses in clinical trials and describe the factors that need to be considered in the planning, monitoring, and reporting of a study involving group sequential hypothesis tests.
Emerson
S S
SS
Epidemiology and Biometry Program, Arizona Cancer Center, Tucson.
Fleming
T R
TR
D015982:Bias; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D004526:Efficiency; D004992:Ethics, Medical; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D012107:Research Design