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UNDERSTANDING CLINICAL TRIAL STATISTICS

UNDERSTANDING CLINICAL TRIAL STATISTICSP repared by Urania Dafni, Xanthi Pedeli, ZoiTsourtiDISCLOSURES Urania Dafni has reported no conflict of interest Xanthi Pedelihas reported no conflict of interest ZoiTsourtihas reported no conflict of interestKEY POINTS Randomization Stratification Superiority Stopping boundaries Planned analysis Kaplan-Meier plots, medians Forest plots Waterfall plotsSTUDY design Experiments answer a scientific question by isolating the intervention and the outcome from extraneous influences What are the goals? Eliminate systematic error (Bias) any effect rendering the observed results not representative of the treatment effect Minimize random error(Precision) inaccuracy of results due to sampling Ensure the generalizabilityof study results Study design is the methodology for achieving these goals eliminate bias randomization and stratification, blinding, choice of design minimize random error establish a sample size sufficient to achieve study goalsRANDOMIZATIONF undamental Principle in comparing interventions:Groups must be alike in all important aspects and only differ in the intervention each group receives.

UNDERSTANDING CLINICAL TRIAL STATISTICS. Prepared by Urania Dafni, Xanthi ... EaSt 6.3.1: a software package for the design and interim monitoring of group sequential clinical trials, Cytel Software Corporation, Cambridge, MA, ... Understanding Clinical Trials Statistics

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