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1Adaptive designs: looking for a needle in the haystack-a new challenge in medical research.
P. Bauer. Statistics in medicine, 27 (10): 1565-80 (Mai 2008)4584<m:linebreak></m:linebreak>PUBM: Print; JID: 8215016; ppublish;<m:linebreak></m:linebreak>Tipus d'estudis; Dissenys adaptatius.
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BiomedicalResearch
BiomedicalResearch:methods
BiomedicalResearch:statistics&numericaldata
Biometry
Biometry:methods
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ComputerSimulation
DataInterpretation
Humans
LikelihoodFunctions
Models
ROCCurve
ResearchDesign
Statistical
BiomedicalResearchBiomedicalResearch:methodsBiomedicalResearch:statistics&numericaldataBiometryBiometry:methodsClinicalTrialsasTopicClinicalTrialsasTopic:methodsComputerSimulationDataInterpretationHumansLikelihoodFunctionsModelsROCCurveResearchDesignStatistical
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1SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.
A. Chan, J. Tetzlaff, P. Gøtzsche, D. Altman, H. Mann, J. Berlin, K. Dickersin, A. Hróbjartsson, K. Schulz, W. Parulekar und 3 andere Autor(en). BMJ (Clinical research ed.), (Januar 2013)7139<m:linebreak></m:linebreak>JID: 8900488; OID: NLM: PMC3541470; epublish;<m:linebreak></m:linebreak>Protocol; RCT.
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Checklist
ClinicalProtocols
ClinicalProtocols:standards
ClinicalTrialsDataMonitoringCommittees
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:standards
ClinicalTrialsasTopic:statistics&numericald
ComputerSecurity
DataCollection
DataCollection:methods
Ethics
Humans
Medical
MedicalAudit
PatientSelection
PracticeGuidelinesasTopic
ProfessionalRole
QualityControl
RandomAllocation
ResearchDesign
ResearchPersonnel
ResearchSupportasTopic
SampleSize
SocialResponsibility
StatisticsasTopic
TimeFactors
TreatmentOutcome
ChecklistClinicalProtocolsClinicalProtocols:standardsClinicalTrialsDataMonitoringCommitteesClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:standardsClinicalTrialsasTopic:statistics&numericaldComputerSecurityDataCollectionDataCollection:methodsEthicsHumansMedicalMedicalAuditPatientSelectionPracticeGuidelinesasTopicProfessionalRoleQualityControlRandomAllocationResearchDesignResearchPersonnelResearchSupportasTopicSampleSizeSocialResponsibilityStatisticsasTopicTimeFactorsTreatmentOutcome
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1Clinical versus statistical considerations in the design and analysis of clinical research.
R. Horwitz, B. Singer, R. Makuch, und C. Viscoli. Journal of clinical epidemiology, 51 (4): 305-7 (April 1998)2897<m:linebreak></m:linebreak>Comparacions múltiples.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:statistics&numericald
DataInterpretation
Humans
ResearchDesign
Statistical
ClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:statistics&numericaldDataInterpretationHumansResearchDesignStatistical
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1Trials to assess equivalence: the importance of rigorous methods.
B. Jones, P. Jarvis, J. Lewis, und A. Ebbutt. BMJ (Clinical research ed.), 313 (7048): 36-9 (Juli 1996)3242<m:linebreak></m:linebreak>Tests d'equivalència.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ConfidenceIntervals
DrugTherapy
Humans
Nonparametric
ReproducibilityofResults
ResearchDesign
SampleSize
SensitivityandSpecificity
Statistics
TherapeuticEquivalency
ClinicalTrialsasTopicClinicalTrialsasTopic:methodsConfidenceIntervalsDrugTherapyHumansNonparametricReproducibilityofResultsResearchDesignSampleSizeSensitivityandSpecificityStatisticsTherapeuticEquivalency
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1Methodological issues in comparative effectiveness research: clinical trials.
P. Peduzzi, T. Kyriakides, T. O'Connor, P. Guarino, S. Warren, und G. Huang. The American journal of medicine, 123 (12 Suppl 1): e8-15 (Dezember 2010)5918<m:linebreak></m:linebreak>CI: Copyright (c) 2010; JID: 0267200; ppublish;<m:linebreak></m:linebreak>CER.
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ChoiceBehavior
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:standards
ComparativeEffectivenessResearch
ComparativeEffectivenessResearch:methods
ComparativeEffectivenessResearch:standards
Humans
MulticenterStudiesasTopic
MulticenterStudiesasTopic:methods
ResearchDesign
ResearchPersonnel
ResearchSubjects
UnitedStates
UnitedStatesDepartmentofVeteransAffairs
ChoiceBehaviorClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:standardsComparativeEffectivenessResearchComparativeEffectivenessResearch:methodsComparativeEffectivenessResearch:standardsHumansMulticenterStudiesasTopicMulticenterStudiesasTopic:methodsResearchDesignResearchPersonnelResearchSubjectsUnitedStatesUnitedStatesDepartmentofVeteransAffairs
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1Assessment of futility in clinical trials.
S. Snapinn, M. Chen, Q. Jiang, und T. Koutsoukos. Pharmaceutical statistics, 5 (4): 273-81 (2006)7401<m:linebreak></m:linebreak>LR: 20071115; JID: 101201192; ppublish;<m:linebreak></m:linebreak>Mesures de contrast; RCT.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
DataInterpretation
EndpointDetermination
Ethics
EvaluationStudiesasTopic
Humans
Medical
Models
MulticenterStudiesasTopic
MyocardialInfarction
MyocardialInfarction:drugtherapy
Probability
ResearchDesign
SampleSize
Statistical
StochasticProcesses
TimeFactors
RCT
ClinicalTrialsasTopicClinicalTrialsasTopic:methodsDataInterpretationEndpointDeterminationEthicsEvaluationStudiesasTopicHumansMedicalModelsMulticenterStudiesasTopicMyocardialInfarctionMyocardialInfarction:drugtherapyProbabilityResearchDesignSampleSizeStatisticalStochasticProcessesTimeFactorsRCT
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1Statistics review 10: further nonparametric methods.
V. Bewick, L. Cheek, und J. Ball. Critical care (London, England), 8 (3): 196-9 (Juni 2004)15153238<m:linebreak></m:linebreak> <m:linebreak></m:linebreak>PUBM: Print-Electronic; DEP: 20040416; JID: 9801902; 2004/04/16 aheadofprint; ppublish;<m:linebreak></m:linebreak> <m:linebreak></m:linebreak>Anàlisi de dades.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:statistics&numericald
DataInterpretation
Humans
Nonparametric
ResearchDesign
Statistical
Statistics
ClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:statistics&numericaldDataInterpretationHumansNonparametricResearchDesignStatisticalStatistics
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1Determining the non-inferiority margin for patient reported outcomes.
C. Gerlinger, und T. Schmelter. Pharmaceutical statistics, 10 (5): 410-3 (2011)6376<m:linebreak></m:linebreak>MDCI; Tests d'equivalència; Mesures de resultats.
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AcneVulgaris
AcneVulgaris:drugtherapy
AcneiformEruptions
AcneiformEruptions:drugtherapy
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
DiscriminantAnalysis
DiseaseProgression
DrugandNarcoticControl
Endometriosis
Endometriosis:complications
Endometriosis:drugtherapy
Female
HotFlashes
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HotFlashes:drugtherapy
Humans
Internationality
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Menopause:drugeffects
Models
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PelvicPain:complications
PharmaceuticalPreparations
PharmaceuticalPreparations:adverseeffects
PharmaceuticalPreparations:metabolism
ROCCurve
ResearchDesign
SelfReport
SelfReport:standards
SensitivityandSpecificity
Statistical
TreatmentOutcome
UnitedStates
UnitedStatesFoodandDrugAdministration
VasomotorSystem
VasomotorSystem:drugeffects
AcneVulgarisAcneVulgaris:drugtherapyAcneiformEruptionsAcneiformEruptions:drugtherapyClinicalTrialsasTopicClinicalTrialsasTopic:methodsDiscriminantAnalysisDiseaseProgressionDrugandNarcoticControlEndometriosisEndometriosis:complicationsEndometriosis:drugtherapyFemaleHotFlashesHotFlashes:complicationsHotFlashes:drugtherapyHumansInternationalityMenopauseMenopause:drugeffectsModelsPatientSatisfactionPelvicPainPelvicPain:complicationsPharmaceuticalPreparationsPharmaceuticalPreparations:adverseeffectsPharmaceuticalPreparations:metabolismROCCurveResearchDesignSelfReportSelfReport:standardsSensitivityandSpecificityStatisticalTreatmentOutcomeUnitedStatesUnitedStatesFoodandDrugAdministrationVasomotorSystemVasomotorSystem:drugeffects
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1The two-period cross-over clinical trial.
M. Hills, und P. Armitage. British journal of clinical pharmacology, 8 (1): 7-20 (Juli 1979)3274<m:linebreak></m:linebreak>Tipus d'estudis.
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AnalysisofVariance
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
DrugInteractions
Humans
Mathematics
ResearchDesign
TimeFactors
AnalysisofVarianceClinicalTrialsasTopicClinicalTrialsasTopic:methodsDrugInteractionsHumansMathematicsResearchDesignTimeFactors
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1Key points in the start and conduct of a clinical trial. From question to reality in an investigator-initiated clinical trial (I).
J. Tur, A. Escudero, L. Iglesias, M. Alos, L. Luque, und B. Burguera. Endocrinología y nutrición : órgano de la Sociedad Española de Endocrinología y Nutrición, 58 (6): 291-8 (2011)6619.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:economics
ClinicalTrialsasTopic:ethics
ClinicalTrialsasTopic:legislation&jurisprude
ClinicalTrialsasTopic:methods
DataCollection
Documentation
GovernmentAgencies
Humans
Medical
OutcomeAssessment(HealthCare)
ResearchDesign
ResearchPersonnel
ResearchReport
ResearchSupportasTopic
Societies
Spain
ClinicalTrialsasTopicClinicalTrialsasTopic:economicsClinicalTrialsasTopic:ethicsClinicalTrialsasTopic:legislation&jurisprudeClinicalTrialsasTopic:methodsDataCollectionDocumentationGovernmentAgenciesHumansMedicalOutcomeAssessment(HealthCare)ResearchDesignResearchPersonnelResearchReportResearchSupportasTopicSocietiesSpain
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1Design of clinical trials.
D. Rollo, S. Machado, und M. Ceschin. Seminars in nuclear medicine, 40 (5): 332-7 (September 2010)5927<m:linebreak></m:linebreak>CI: Copyright 2010; JID: 1264464; 0 (Radiopharmaceuticals); ppublish;<m:linebreak></m:linebreak>Disseny; Tipus d'estudis; RCT.
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Bias(Epidemiology)
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
DiagnosticImaging
Disclosure
Drug-RelatedSideEffectsandAdverseReactions
DrugLabeling
EarlyTerminationofClinicalTrials
EpidemiologicResearchDesign
Humans
NuclearMedicine
NuclearMedicine:methods
Radiopharmaceuticals
Radiopharmaceuticals:adverseeffects
Radiopharmaceuticals:diagnosticuse
Radiopharmaceuticals:economics
Radiopharmaceuticals:supply&distribution
ResearchDesign
SocialResponsibility
TimeFactors
Bias(Epidemiology)ClinicalTrialsasTopicClinicalTrialsasTopic:methodsDiagnosticImagingDisclosureDrug-RelatedSideEffectsandAdverseReactionsDrugLabelingEarlyTerminationofClinicalTrialsEpidemiologicResearchDesignHumansNuclearMedicineNuclearMedicine:methodsRadiopharmaceuticalsRadiopharmaceuticals:adverseeffectsRadiopharmaceuticals:diagnosticuseRadiopharmaceuticals:economicsRadiopharmaceuticals:supply&distributionResearchDesignSocialResponsibilityTimeFactors
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1Are we doing any good by doing really well? (Where's the Bacon?).
D. Herbert. Medical physics, 30 (4): 489-94 (April 2003)3511<m:linebreak></m:linebreak>Publicació.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:standards
ClinicalTrialsasTopic:trends
Databases
Evidence-BasedMedicine
Evidence-BasedMedicine:methods
Evidence-BasedMedicine:standards
Evidence-BasedMedicine:trends
Factual
Factual:standards
Factual:trends
PeerReview
PeerReview:methods
PeerReview:standards
PeriodicalsasTopic
PeriodicalsasTopic:standards
PeriodicalsasTopic:trends
QualityControl
Research
Research:trends
ResearchDesign
ClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:standardsClinicalTrialsasTopic:trendsDatabasesEvidence-BasedMedicineEvidence-BasedMedicine:methodsEvidence-BasedMedicine:standardsEvidence-BasedMedicine:trendsFactualFactual:standardsFactual:trendsPeerReviewPeerReview:methodsPeerReview:standardsPeriodicalsasTopicPeriodicalsasTopic:standardsPeriodicalsasTopic:trendsQualityControlResearchResearch:trendsResearchDesign
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1A primer on the design, conduct, and interpretation of clinical trials.
L. Appel. Clinical journal of the American Society of Nephrology : CJASN, 1 (6): 1360-7 (November 2006)5015<m:linebreak></m:linebreak>LR: 20071115; JID: 101271570; 2006/10/11 aheadofprint; ppublish;<m:linebreak></m:linebreak>Disseny; Introductori; RCT; Nefrologia.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:standards
FactorAnalysis
Humans
PatientSelection
RandomizedControlledTrialsasTopic:standards
ResearchDesign
Statistical
RCT
ClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:standardsFactorAnalysisHumansPatientSelectionRandomizedControlledTrialsasTopic:standardsResearchDesignStatisticalRCT
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1Benefits, challenges and obstacles of adaptive clinical trial designs.
S. Chow, und R. Corey. Orphanet journal of rare diseases, (Januar 2011)6593<m:linebreak></m:linebreak>GR: 2P30 AI064518/AI/NIAID NIH HHS/United States; JID: 101266602; OID: NLM: PMC3248853; 2011/08/22 received; 2011/11/30 accepted; 2011/11/30 aheadofprint; epublish;<m:linebreak></m:linebreak>Tipus d'estudis; Dissenys adaptatius.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:standards
DataInterpretation
Dose-ResponseRelationship
Drug
DrugIndustry
DrugIndustry:standards
EndpointDetermination
Humans
ResearchDesign
SampleSize
Statistical
TreatmentOutcome
UnitedStates
UnitedStatesFoodandDrugAdministration
ClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:standardsDataInterpretationDose-ResponseRelationshipDrugDrugIndustryDrugIndustry:standardsEndpointDeterminationHumansResearchDesignSampleSizeStatisticalTreatmentOutcomeUnitedStatesUnitedStatesFoodandDrugAdministration
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1Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes.
D. Revicki, R. Hays, D. Cella, und J. Sloan. Journal of clinical epidemiology, 61 (2): 102-9 (Februar 2008)4488<m:linebreak></m:linebreak>PUBM: Print-Electronic; GR: AG-02-004/AG/United States NIA; GR: AG20679-01/AG/United States NIA; GR: P20-MD00148-01/MD/United States NCMHD; JID: 8801383; RF: 52; 2006/10/06 received; 2007/03/27 revised; 2007/03/31 accepted; 2007/08/03 aheadofprint; ppublish;<m:linebreak></m:linebreak>MDCI.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
DataInterpretation
HealthStatusIndicators
Humans
OutcomeAssessment(HealthCare)
OutcomeAssessment(HealthCare):methods
PatientSatisfaction
QualityofLife
ResearchDesign
Statistical
TreatmentOutcome
ClinicalTrialsasTopicClinicalTrialsasTopic:methodsDataInterpretationHealthStatusIndicatorsHumansOutcomeAssessment(HealthCare)OutcomeAssessment(HealthCare):methodsPatientSatisfactionQualityofLifeResearchDesignStatisticalTreatmentOutcome
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1Outcome based subgroup analysis: a neglected concern.
K. Hirji, und M. Fagerland. Trials, (Januar 2009)5228<m:linebreak></m:linebreak>JID: 101263253; OID: NLM: PMC2693510; 2008/12/09 received; 2009/05/20 accepted; 2009/05/20 aheadofprint; epublish;<m:linebreak></m:linebreak>Comparacions múltiples; Anàlisi de subgrups; RCT.
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Bias(Epidemiology)
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:statistics&numericald
DataInterpretation
Humans
ReproducibilityofResults
ResearchDesign
Statistical
SurvivalAnalysis
TreatmentOutcome
Bias(Epidemiology)ClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:statistics&numericaldDataInterpretationHumansReproducibilityofResultsResearchDesignStatisticalSurvivalAnalysisTreatmentOutcome
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1Noninferiority hypotheses and choice of noninferiority margin.
T. Ng. Statistics in medicine, 27 (26): 5392-406 (November 2008)4579<m:linebreak></m:linebreak>PUBM: Print; JID: 8215016; ppublish;<m:linebreak></m:linebreak>Tests d'equivalència.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ComputerSimulation
DataInterpretation
EndpointDetermination
EndpointDetermination:methods
Humans
ProportionalHazardsModels
ResearchDesign
Statistical
ClinicalTrialsasTopicClinicalTrialsasTopic:methodsComputerSimulationDataInterpretationEndpointDeterminationEndpointDetermination:methodsHumansProportionalHazardsModelsResearchDesignStatistical
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1Introduction to clinical research in dermatology: the link between clinical practice and research.
I. García-Doval, und L. Naldi. Actas dermo-sifiliográficas, 100 (9): 749-55 (November 2009)5988<m:linebreak></m:linebreak>JID: 0373062; RF: 2; ppublish;;<m:linebreak></m:linebreak>Recursos/Organització; Recerca clínica; Dermatologia.
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ClinicalTrialsasTopic
ClinicalTrialsasTopic:ethics
ClinicalTrialsasTopic:methods
CohortStudies
Dermatology
Humans
ResearchDesign
SkinDiseases
SkinDiseases:therapy
Spain
TranslationalMedicalResearch
ClinicalTrialsasTopicClinicalTrialsasTopic:ethicsClinicalTrialsasTopic:methodsCohortStudiesDermatologyHumansResearchDesignSkinDiseasesSkinDiseases:therapySpainTranslationalMedicalResearch
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1Power and sample size for clinical trials when efficacy is required in multiple endpoints: application to an Alzheimer's treatment trial.
C. Xiong, K. Yu, F. Gao, Y. Yan, und Z. Zhang. Clinical trials (London, England), 2 (5): 387-93 (Januar 2005)4845<m:linebreak></m:linebreak>LR: 20071115; GR: AG 03991/AG/NIA NIH HHS/United States; GR: AG 05681/AG/NIA NIH HHS/United States; JID: 101197451; ppublish;<m:linebreak></m:linebreak>Sample size; Comparacions múltiples.
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AlzheimerDisease
AlzheimerDisease:therapy
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:statistics&numericald
DataInterpretation
Humans
ResearchDesign
SampleSize
Statistical
TreatmentOutcome
AlzheimerDiseaseAlzheimerDisease:therapyClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:statistics&numericaldDataInterpretationHumansResearchDesignSampleSizeStatisticalTreatmentOutcome
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1Using balance statistics to determine the optimal number of controls in matching studies.
A. Linden, und S. Samuels. Journal of evaluation in clinical practice, 19 (5): 968-75 (Oktober 2013)CI: (c) 2013; JID: 9609066; OTO: NOTNLM; 2013/07/02 accepted; aheadofprint;.
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Bias(Epidemiology)
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
ClinicalTrialsasTopic:standards
DataInterpretation
Humans
OutcomeAssessment(HealthCare)
OutcomeAssessment(HealthCare):methods
OutcomeAssessment(HealthCare):statistics&num
ResearchDesign
ResearchDesign:standards
SampleSize
Statistical
TreatmentOutcome
Bias(Epidemiology)ClinicalTrialsasTopicClinicalTrialsasTopic:methodsClinicalTrialsasTopic:standardsDataInterpretationHumansOutcomeAssessment(HealthCare)OutcomeAssessment(HealthCare):methodsOutcomeAssessment(HealthCare):statistics&numResearchDesignResearchDesign:standardsSampleSizeStatisticalTreatmentOutcome
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1Adaptive designs: looking for a needle in the haystack-a new challenge in medical research.

1SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

1Clinical versus statistical considerations in the design and analysis of clinical research.

1Trials to assess equivalence: the importance of rigorous methods.

1Methodological issues in comparative effectiveness research: clinical trials.

1Assessment of futility in clinical trials.

1Statistics review 10: further nonparametric methods.

1Determining the non-inferiority margin for patient reported outcomes.

1The two-period cross-over clinical trial.

1Key points in the start and conduct of a clinical trial. From question to reality in an investigator-initiated clinical trial (I).

1Design of clinical trials.

1Are we doing any good by doing really well? (Where's the Bacon?).

1A primer on the design, conduct, and interpretation of clinical trials.

1Benefits, challenges and obstacles of adaptive clinical trial designs.

1Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes.

1Outcome based subgroup analysis: a neglected concern.

1Noninferiority hypotheses and choice of noninferiority margin.

1Introduction to clinical research in dermatology: the link between clinical practice and research.

1Power and sample size for clinical trials when efficacy is required in multiple endpoints: application to an Alzheimer's treatment trial.

1Using balance statistics to determine the optimal number of controls in matching studies.

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