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1Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working Group.
P. Gallo, C. Chuang-Stein, V. Dragalin, B. Gaydos, M. Krams, and J. Pinheiro. Journal of biopharmaceutical statistics, 16 (3): 275-83; discussion 285-91, 293-8, 311-2 (May 2006)5002<br/>LR: 20071115; JID: 9200436; CIN: J Biopharm Stat. 2006 May;16(3):299-309; discussion 311-2. PMID: 16724486; ppublish;<br/>Tipus d'estudis; Dissenys adaptatius.
2 years ago by @jepcastel
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ResearchDesign
ClinicalTrialsDataMonitoringCommittees
GuidelinesasTopic
Humans
DrugIndustry:standards
UnitedStatesFoodandDrugAdministration:standa
Dose-ResponseRelationship
UnitedStatesFoodandDrugAdministration
DataInterpretation
BiomedicalResearch
DrugIndustry
SampleSize
ClinicalTrialsasTopic:standards
Statistical
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
UnitedStates
Drug
ResearchDesignClinicalTrialsDataMonitoringCommitteesGuidelinesasTopicHumansDrugIndustry:standardsUnitedStatesFoodandDrugAdministration:standaDose-ResponseRelationshipUnitedStatesFoodandDrugAdministrationDataInterpretationBiomedicalResearchDrugIndustrySampleSizeClinicalTrialsasTopic:standardsStatisticalClinicalTrialsasTopicClinicalTrialsasTopic:methodsUnitedStatesDrug
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2Challenging Issues in Clinical Trial Design: Part 4 of a 4-Part Series on Statistics for Clinical Trials.
S. Pocock, T. Clayton, and G. Stone. Journal of the American College of Cardiology, 66 (25): 2886-98 (December 2015)Disseny; Dissenys adaptatius; Tests d'equivalència; Early stopping; RCT; Introductori; CV<br/><br/>Molts exemples i bons gràfics.
2 years ago by @jepcastel
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ClinicalTrialsDataMonitoringCommittees
GuidelinesasTopic
Humans
Cardiology:methods
Statistical
ClinicalTrialsasTopic:statistics&numericald
ClinicalTrialsasTopic
DataInterpretation
Cardiology
ClinicalTrialsDataMonitoringCommitteesGuidelinesasTopicHumansCardiology:methodsStatisticalClinicalTrialsasTopic:statistics&numericaldClinicalTrialsasTopicDataInterpretationCardiology
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1Early stopping rules in oncology: considerations for clinicians.
S. Mukherjee, J. Goffin, V. Taylor, K. Anderson, and G. Pond. European journal of cancer (Oxford, England : 1990), 47 (16): 2381-6 (November 2011)Comparacions múltiples; Early stopping; RCT; Oncologia.
2 years ago by @jepcastel
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RCT
ClinicalTrialsDataMonitoringCommittees
Humans
RandomizedControlledTrialsasTopic:statistics
EarlyTerminationofClinicalTrials
RandomizedControlledTrialsasTopic:ethics
BayesTheorem
DataInterpretation
EarlyTerminationofClinicalTrials:methods
Ethics
EarlyTerminationofClinicalTrials:standards
Statistical
EarlyTerminationofClinicalTrials:statistics&
Medical
RCTClinicalTrialsDataMonitoringCommitteesHumansRandomizedControlledTrialsasTopic:statisticsEarlyTerminationofClinicalTrialsRandomizedControlledTrialsasTopic:ethicsBayesTheoremDataInterpretationEarlyTerminationofClinicalTrials:methodsEthicsEarlyTerminationofClinicalTrials:standardsStatisticalEarlyTerminationofClinicalTrials:statistics&Medical
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1Les méthodes adaptatives : quand et comment les utiliser dans les essais cliniques ?
R. Porcher, B. Lecocq, M. Vray, A. D’Andon, F. Bassompierre, J. Béhier, C. Belorgey, J. Bénichou, G. Berdeaux, L. Bergougnoux and 20 other author(s). Thérapie, 66 (4): 309-317 (July 2011)Tipus d'estudis; Dissenys adaptatius; RCT; Introductori.
2 years ago by @jepcastel
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PhaseIasTopic:methods
ClinicalTrials
ResearchDesign
OrganizationandAdministration
ClinicalTrialsDataMonitoringCommittees
PhaseIasTopic:statistics&numericaldata
ClinicalTrialsasTopic:statistics&numericald
PhaseIasTopic
BayesTheorem
DataInterpretation
SampleSize
ResearchDesign:statistics&numericaldata
PhaseIIasTopic
Statistical
ClinicalTrialsasTopic
ClinicalTrialsasTopic:methods
PhaseIasTopic:methodsClinicalTrialsResearchDesignOrganizationandAdministrationClinicalTrialsDataMonitoringCommitteesPhaseIasTopic:statistics&numericaldataClinicalTrialsasTopic:statistics&numericaldPhaseIasTopicBayesTheoremDataInterpretationSampleSizeResearchDesign:statistics&numericaldataPhaseIIasTopicStatisticalClinicalTrialsasTopicClinicalTrialsasTopic:methods
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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 and 3 other author(s). BMJ (Clinical research ed.), (January 2013)7139<m:linebreak></m:linebreak>JID: 8900488; OID: NLM: PMC3541470; epublish;<m:linebreak></m:linebreak>Protocol; RCT.
2 years ago by @jepcastel
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PatientSelection
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Checklist
Medical
StatisticsasTopic
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DataCollection:methods
ResearchSupportasTopic
ClinicalTrialsDataMonitoringCommittees
Humans
ClinicalTrialsasTopic:statistics&numericald
TimeFactors
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ClinicalTrialsasTopic:standards
ComputerSecurity
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TreatmentOutcome
SocialResponsibility
PatientSelectionResearchDesignQualityControlProfessionalRoleEthicsRandomAllocationClinicalProtocolsSampleSizeResearchPersonnelMedicalAuditDataCollectionChecklistMedicalStatisticsasTopicClinicalTrialsasTopic:methodsDataCollection:methodsResearchSupportasTopicClinicalTrialsDataMonitoringCommitteesHumansClinicalTrialsasTopic:statistics&numericaldTimeFactorsClinicalProtocols:standardsPracticeGuidelinesasTopicClinicalTrialsasTopic:standardsComputerSecurityClinicalTrialsasTopicTreatmentOutcomeSocialResponsibility
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1The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it.
R. O'Neill, and R. Temple. Clinical pharmacology and therapeutics, 91 (3): 550-4 (March 2012)Dades censurades; RCT; Regulació; Imputació múltiple; LOCF.
2 years ago by @jepcastel
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DrugApproval
ClinicalTrialsDataMonitoringCommittees
Humans
InformationStorageandRetrieval
ClinicalTrialsasTopic:standards
Statistical
UnitedStatesFoodandDrugAdministration
ClinicalTrialsasTopic
DataInterpretation
UnitedStates
DrugApprovalClinicalTrialsDataMonitoringCommitteesHumansInformationStorageandRetrievalClinicalTrialsasTopic:standardsStatisticalUnitedStatesFoodandDrugAdministrationClinicalTrialsasTopicDataInterpretationUnitedStates
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1Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working Group.

2Challenging Issues in Clinical Trial Design: Part 4 of a 4-Part Series on Statistics for Clinical Trials.

1Early stopping rules in oncology: considerations for clinicians.

1Les méthodes adaptatives : quand et comment les utiliser dans les essais cliniques ?

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

1The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it.

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