StrategyandStatisticsinClinicalTrialsStrategyandStatisticsinClinicalTrialsANon-Statistician’sGuidetoThinking,Designing,andExecutingJosephTalAMSTERDAM•BOSTON•HEIDELBERG•LONDONNEWYORK•OXFORD•PARIS•SANDIEGOSANFRANCISCO•SINGAPORE•SYDNEY•TOKYOAcademicPressisanimprintofElsevierAcademicPressisanimprintofElsevier225WymanStreet,Waltham,MA02451,USATheBoulevard,LangfordLane,Kidlington,Oxford,OX51GB,UK©2011ElsevierInc.Allrightsreserved.Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopying,recording,oranyinformationstorageandretrievalsystem,withoutpermissioninwritingfromthePublisher.Detailsonhowtoseekpermission,furtherinformationaboutthePublisher’spermissionspolicies,andourarrangementswithorganizationssuchastheCopyrightClearanceCenterandtheCopyrightLicensingAgency,canbefoundatourwebsite:www.elsevier.com/permissionsThisbookandtheindividualcontributionscontainedinitareprotectedundercopyrightbythePublisher(otherthanasmaybenotedherein).LibraryofCongressCataloging-in-PublicationDataTal,Joseph.Strategyandstatisticsinclinicaltrials:anon-statisticiansguidetothinking,designing,andexecuting/JosephTal.p.cm.ISBN978-0-12-386909-81.Clinicaltrials–Statisticalmethods.I.Title.R853.C55T352011615.5072'4–dc222011009725BritishLibraryCataloguing-in-PublicationDataAcataloguerecordforthisbookisavailablefromtheBritishLibrary.ForinformationonallAcademicPresspublicationsvisitourwebsiteatwww.elsevierdirect.comPrintedintheUnitedStatesofAmerica11121314987654321NoticesKnowledgeandbestpracticeinthisfieldareconstantlychanging.Asnewresearchandexperiencebroadenourunderstanding,changesinresearchmethods,professionalpractices,ormedicaltreatmentmaybecomenecessary.Practitionersandresearchersmustalwaysrelyontheirownexperienceandknowledgeinevaluatingandusinganyinformation,methods,compounds,orexperimentsdescribedherein.Inusingsuchinformationormethodstheyshouldbemindfuloftheirownsafetyandthesafetyofothers,includingpartiesforwhomtheyhaveaprofe...
