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1、STATISTICSINMEDICINE,VOL.13,1297-1312(1994)THECHARTTRIALS:BAYESIANDESIGNANDMONITORINGINPRACTICEMAHESHK.B.PARMARMRCCancerTrialsOfice.5ShafieshuryRoad.CambridgeCB22BW.U.K.DAVIDJ.SPIEGELHALTERMRCBinrraristiciUnit.Insritureof'PublicHeulrh,Unioersitb,FerricSire.RobinsonWay.Can
2、lbriclgeCB22SR.[IKLAURENCES.FREEDMANBiomerr!Brunch.Divisionof'CancerPreuentinnandConirol,NationalCancerInsrirure.Bethesdu,Marjiand.20892.US.AandtheCHARTSTEERINGCOMMITTEE*SUMMARYInthispaperwedescribethedesignandmonitoringoftwolargerandomizedtrialsbeingconductedthroughtheBr
3、itishMedicalResearchCouncil(MRC)CancerTrialsOffice.Inparticularwediscusstheissuesinvolvedinthedesignofthetrials,specifyingthenullandalternativehypothesesandhowthedesignhasinfluencedthemonitoringprocedureused.Fromthesetwoexamples,andsomeotherMRCexperiences,wesuggestsomebas
4、icconsiderationswhichcouldbeappliedtomanyMRCandothertrials.BACKGROUNDTOTHETRIALSRadicalradiotherapy,treatmentaimedatcure,formosttypesofcancerisusuallygivenoncedaily,withnotreatmentatweekends,foraperiodofbetween54and7weeks.Inthemid-1980sevidenceemerged'thatsometumourscould
5、repopulatebetweentreatmentsessions.Thus,in1986itwassuggested'thatradiotherapytreatmentshouldbecontinuous,withnointerruptionforweekends,topreventrepopulation;itwasalsosuggestedthatitshouldbehyperfractionated,withthree'smalldose'treatmentsperdaytoreducethelatemorbidity,andf
6、inallyaccelerated,givenovertwelvedays,sothattreatmentwascompletedbeforeanyacutemorbiditystartedandpreventedthetreatmentbeingcompleted.ThesethreecomponentsofthetherapyledtotheacronymCHART(ContinuousHyperfractionatedAcceleratedRadioTherapy).IntwosinglearmphaseI1trialsconduc
7、tedbetween1985and1988,3*467patientswithheadandneckcancerand65patientswithnon-small-celllungcancerweretreatedwiththistherapyandtheresultswerevery*CHARTSteeringCommittee:A.Barrett(Chairperson).C.K.Bomford,B.Cottier,D.Coyle.P.J.K.Dawes,S.Dische.M.F.Drummond,C.Gafhey,D.Gibson
8、,A.Harvey,J.M.Henk,A.Galpine,D.A.L.Morgan,J.Morris,H.Newman,M.K.B.Parmar,A.G.Robertson,M.H.Robin
