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randomizeR
:AnRPackagefortheAssessmentand
ImplementationofRandomizationinClinicalTrials
DianeUschner
RWTHAachenUniversity
DavidSchindler
RWTHAachenUniversity
NicoleHeussen
RWTHAachenUniversity
Ralf-DieterHilgers
RWTHAachenUniversity
Abstract
Thisintroductiontothe
R
package
randomizeR
isaslightlymodidversionof
Uschner,Schindler,Hilgers,andHeussen
(
2018
).
Randomizationinclinicaltrialsisthekeydesigntechniquetoensurethecomparability
oftreatmentgroups.Althoughthereexistalargenumberofsoftwareproductswhich
assisttheresearchertoimplementrandomization,notoolwhichcoversawiderange
ofproceduresandallowsthecomparativeevaluationoftheproceduresunderpractical
restrictionshasbeenproposedintheliterature.
TheRpackage
randomizeR
addressesthisneed.Thepaperincludesadetailedde-
scriptionofthe
randomizeR
packagethatservesasatutorialforthegenerationofran-
domizationsequencesandtheassessmentofrandomizationprocedures.
Keywords
:restrictedrandomizationprocedure,selectionbias,chronologicalbias,
R
.
1.Introduction
Randomizationisadesigntechniquetoensurethecomparabilityoftreatmentgroupsinclin-
icaltrialsbyintroducingadeliberateelementofchance.
Armitage
(
1982
)statesthethree
maingoalsthataresupposedtobeachievedbyrandomization.First,ittendstobalance
knownandunknowncovariatesand,thus,toproducestructuralequalityofthetreatment
groups.Second,byensuringctiveblindingoftreatmentallocationsfrominvestigatorsand
patients,randomizationhelpstoavoidbiascausedbytheselectionofpatients.Finally,ran-
domizationcontributestotheinternalvalidityofatrialthatprovidesthebasisforstatistical
inference.Theimportanceofrandomizationforclinicaltrialswasstnotedinthe1940sby
SirA.BradfordHill(see
Chalmers
1999
)whorealizedthatsuccessfulblindingoftreatment
allocationswasimpossiblewithoutrandomization.Sincethattime,regulatorshaveadvocated
theuseofrandomizationintheirguidelines(seeforexample
ICHE9
1998
)andseveralder-
entrandomizationprocedureshavebeenproposedintheliterature.Ithasbeennoticedthat
derentrandomizationproceduresbehavedirently,e.g.,concerningtheirsusceptibilityto
biasandtheirpotentialtocontrolpowerandtype-I-errorprobability.Anoverviewcontaining
thelatestdevelopmentscanbefoundin
RosenbergerandLachin
(
2016
).
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