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Lea
Drye,
PhDJohnsHopkinsUniversityTypesofTrialDesignCopyright©2023JohnsHopkinsUniversityandLeaDrye.
AllRightsReserved.
Phase
I:First
stage
in
testing
a
new
intervention
in
humansUsually
10-30
peopleIdentify
tolerable
dose,
provide
information
on
drug
metabolism,excretion,
and
toxicityOften
not
controlled
Phase
II:Usually
30-100
peoplePreliminary
information
on
efficacy,
additional
information
onsafety
and
side
effects
Phase
III:Usually
100+
peopleAssess
efficacy
and
safetyControlled,
usually
randomized2Phases
of
trialsLectureOutline
DiscussvarioustrialdesigntypesParallelCrossoverGroupallocationFactorialLargesimpleEquivalencyNon-inferiorityAdaptive3ComparisonStructure:Parallel,Crossover,andGroupAllocationDesignsSectionAThematerialinthisvideoissubjecttothecopyrightoftheownersofthematerialandisbeingprovidedforeducationalpurposesunderrulesoffairuseforregisteredstudentsinthiscourseonly.Noadditionalcopiesofthecopyrightedworkmaybemadeordistributed.ParallelDesign5
Simultaneoustreatmentandcontrolgroups
Eachpersonisrandomlyassignedtoonetreatmentgroup
Randomizationremovestreatmentselectionbiasandpromotescomparabilityoftreatmentgroups
Statisticalcomparisonsmadebetweentreatmentgroups|P叫ωe G巾Randomized「占v1,白6iJHSPHParallelDesignExample:NETTSource:NETT
ResearchGroup(1999).Chest1999;116:
1750-61;
NETT
Research
Group
(1999).
JThoracCardiovascSurg,118:
518-528;
Fishman,
A.,&Martinez,F.,et
al.(2023).
NEnglJMed348:
2059-73.7
National
Emphysema
Treatment
Trial
(NETT)- PhaseIIItrial,unmaskedPopulationPeoplewithsevereemphysemaSamplesize1,200AllocationtotreatmentRandomizedTreatments—Lungvolumereductionsurgeryplusmedical
therapy—Medical
therapy(standardtherapycontrol)ParallelDesignExample:NETTSource:NETT
ResearchGroup(1999).Chest1999;116:
1750-61;
NETT
Research
Group
(1999).
JThoracCardiovascSurg,118:
518-528;
Fishman,
A.,&Martinez,F.,et
al.(2023).
NEnglJMed348:
2059-73.8HypothesistestingSuperiorityOutcomes—Primary:mortality,exercisecapacity—Secondary:qualityoflife,symptoms,lungfunctionandmechanics,functionalcapacityFollow-upUpto
7.5
yearsNumberofrecruitingcentersMulti-center
(17)CrossoverDesign9
RandomizationoforderinwhichtreatmentsarereceivedABorBARandomizationpromotesbalancebetweentreatmentgroupsintimingofexposure
TestingofbothtreatmentsineachpatientEachpatientservesashis/herowncontrolVariabilityreduced
becauselessvariabilitywithin
patient
thanbetween
patients
FewerpatientsneededCrossoverDesignGraphWashout10Group1,
Tx
AGroup1,
TxBGroup2,
TxBGroup2,
Tx
ACrossoverDesign:Disadvantages11
Treatmentcan’thavepermanent
effects
orcures
Potentialcarry-overeffectsoffirst-periodtreatmenttosecondperiodWashoutneedstobelongenoughUnequal
carry-over
effectsTreatmentduringwashout
Testforperiodbytreatmentinteractionsnotpowerful
Dropoutsmoresignificant
AnalysismaybemoredifficultCrossoverDesign:Uses12
ConstantintensityofunderlyingdiseaseChronic
diseases—asthma,
hypertension,
arthritis
Short-termtreatmenteffectsReliefofsignsorsymptomsofdisease
Metabolic,bioavailability,ortolerabilitystudiesCrossoverDesign:Examples13
Evening-dosevs.morning-dosedtravoprostinopen-angleglaucomafor24-hourintraocularpressurecontrol
Montelukastvs.salmeterol
as
adjuvant
to
inhaled
fluticasone
forexercise-inducedasthmainchildren
Topicaloilvs.placeboforneuropathicpainGroupAllocationDesign14
Alsoknownas
“cluster
randomization”
Randomizationunitisagroupofindividuals(community,school,clinic)
Individual
randomizationand
interventionis
notfeasibleor
isunacceptableTrackingContamination
Ifthereisacorrelationintheresponseswithinagroup,designlosessomeefficiency(moreindividualsrequired)lα[Ij川臼15Randomized〈〈Group
Allocation
Example:
Sommer
Vit
A
trial16Lancet.
1986
May
24;1(8491):1169-73
PopulationPreschool
children
in
northern
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