SlideShare a Scribd company logo

Dragalin Flexible Design

•Download as PPT, PDF•
•
H
heominkyu
BusinessHealth & Medicine
1 of 21
Flexible designs for pivotal clinical trials Vlad Dragalin, RSU-SDS-BDS-GSK FDA/Industry Workshop Session: Flexible Designs – Are We Ready Yet? Washington, D.C., September 14-16, 2005
Declaimer ,[object Object],[object Object],[object Object]
Acknowledgment ,[object Object],[object Object],[object Object]
Outline ,[object Object],[object Object],[object Object],[object Object]
What are Adaptive Designs? ,[object Object],[object Object],[object Object],PROTOCOL AMENDMENTS
General Structure of Adaptive Designs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Adaptive Design Process Decision Rule New Patient Sampling Rule Stopping Rule Allocation Rule Data
GSK Experience ,[object Object],[object Object],[object Object],[object Object],[object Object]
Background ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Study Designs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Team Concerns ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Details of the Design Primary Endpoint: Primary Goal: Target Difference: STDeviation: Type I error: Power: Traditional Dsgn: Adaptive Dsgn: Efficacy Bndry: Futility Bndry: Inflation Factor: PI-NRS change from Baseline at 8 th W of treatment Comparison of three SBx doses (LD, MD, HD) with Plb 1.3 units 2.1 units  = 0.05 (adjustment for multiplicity  = 0.05/3 = 0.017) 90% 4 parallel groups - 72 patients/per arm (total 288) 3 stage inverse-normal combination test O’Brien-Fleming type nominal levels: (0.0006, 0.014, 0.0235) nominal levels: (0.5, 0.5) 1.025 - maximum 75 patients/arm
1 2 3 4 11 5 6 7 8 9 10 Month Enrollment Period 1st Stage Data Plb MD LD HD 3rd IA 2nd IA 1st IA Randomization CRO 0 8w 2w 1st Stage ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Timing by 80% CP GSK Steering Committee
1 2 3 4 11 5 6 7 8 9 10 Month Enrollment Period 1st Stage Data Plb MD HD 3rd IA 2nd IA 1st IA Randomization CRO 0 8w 2w 2nd Stage 2nd Stage Data GSK Steering Committee ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1 2 3 4 11 5 6 7 8 9 10 Month Enrollment Period 1st Stage Data Plb MD 3rd IA 2nd IA 1st IA Randomization CRO 0 8w 2w 3rd Stage 2nd Stage Data GSK Steering Committee 3rd Stage Data ,[object Object],[object Object],[object Object],[object Object]
Interim Analyses: Data For each arm at each stage
Interim Analyses: Test Null Hypothesis: Estimate of mean 8 th W endpoint: Standardized Test Statistics: Reduced Variance:
Multiplicity Adjustment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Design Properties Parallel 4 arm Dsgn: 72 per arm
Points to Consider ,[object Object],[object Object],[object Object],[object Object],[object Object]
Points to Consider ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Recommended

Cadth 2015 e4 lourenco adaptive design april 2015 final
Cadth 2015 e4 lourenco adaptive design april 2015 finalCadth 2015 e4 lourenco adaptive design april 2015 final
Cadth 2015 e4 lourenco adaptive design april 2015 finalCADTH Symposium
 
Cadth 2015 e4 adaptive design april 2015 final lourenco
Cadth 2015 e4 adaptive design april 2015 final lourencoCadth 2015 e4 adaptive design april 2015 final lourenco
Cadth 2015 e4 adaptive design april 2015 final lourencoCADTH Symposium
 
2011 JSM - Good Statistical Practices
2011 JSM - Good Statistical Practices2011 JSM - Good Statistical Practices
2011 JSM - Good Statistical PracticesTerry Liao
 
Bayesian clinical trials: software and logistics
Bayesian clinical trials: software and logisticsBayesian clinical trials: software and logistics
Bayesian clinical trials: software and logisticsJohn Cook
 
Clinical data-management-overview
Clinical data-management-overviewClinical data-management-overview
Clinical data-management-overviewAcri India
 
Efficient Data Reviews and Quality in Clinical Trials - Kelci Miclaus
Efficient Data Reviews and Quality in Clinical Trials - Kelci MiclausEfficient Data Reviews and Quality in Clinical Trials - Kelci Miclaus
Efficient Data Reviews and Quality in Clinical Trials - Kelci MiclausQuanticate
 
Cdm
CdmCdm
Cdmmanishw21
 
Imaging Endpoints for Clinical Trials by Kenneth G. Faulkner, Ph.D., Corporat...
Imaging Endpoints for Clinical Trials by Kenneth G. Faulkner, Ph.D., Corporat...Imaging Endpoints for Clinical Trials by Kenneth G. Faulkner, Ph.D., Corporat...
Imaging Endpoints for Clinical Trials by Kenneth G. Faulkner, Ph.D., Corporat...PAREXEL International
 

Recommended

Cadth 2015 e4 lourenco adaptive design april 2015 final
Cadth 2015 e4 lourenco adaptive design april 2015 finalCadth 2015 e4 lourenco adaptive design april 2015 final
Cadth 2015 e4 lourenco adaptive design april 2015 finalCADTH Symposium
 
Cadth 2015 e4 adaptive design april 2015 final lourenco
Cadth 2015 e4 adaptive design april 2015 final lourencoCadth 2015 e4 adaptive design april 2015 final lourenco
Cadth 2015 e4 adaptive design april 2015 final lourencoCADTH Symposium
 
2011 JSM - Good Statistical Practices
2011 JSM - Good Statistical Practices2011 JSM - Good Statistical Practices
2011 JSM - Good Statistical PracticesTerry Liao
 
Bayesian clinical trials: software and logistics
Bayesian clinical trials: software and logisticsBayesian clinical trials: software and logistics
Bayesian clinical trials: software and logisticsJohn Cook
 
Clinical data-management-overview
Clinical data-management-overviewClinical data-management-overview
Clinical data-management-overviewAcri India
 
Efficient Data Reviews and Quality in Clinical Trials - Kelci Miclaus
Efficient Data Reviews and Quality in Clinical Trials - Kelci MiclausEfficient Data Reviews and Quality in Clinical Trials - Kelci Miclaus
Efficient Data Reviews and Quality in Clinical Trials - Kelci MiclausQuanticate
 
Cdm
CdmCdm
Cdmmanishw21
 
Imaging Endpoints for Clinical Trials by Kenneth G. Faulkner, Ph.D., Corporat...
Imaging Endpoints for Clinical Trials by Kenneth G. Faulkner, Ph.D., Corporat...Imaging Endpoints for Clinical Trials by Kenneth G. Faulkner, Ph.D., Corporat...
Imaging Endpoints for Clinical Trials by Kenneth G. Faulkner, Ph.D., Corporat...PAREXEL International
 
Clinical research and clinical data management - Ikya Global
Clinical research and clinical data management - Ikya GlobalClinical research and clinical data management - Ikya Global
Clinical research and clinical data management - Ikya Globalikya global
 
Are we using the correct quality goals?
Are we using the correct quality goals?Are we using the correct quality goals?
Are we using the correct quality goals?Ola Elgaddar
 
clinical data management
clinical data managementclinical data management
clinical data managementsopi_1234
 
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Bhaswat Chakraborty
 
causes of laboratory errors
causes of laboratory errorscauses of laboratory errors
causes of laboratory errorsShahad Bakhdar
 
Clinical Data Management
Clinical Data ManagementClinical Data Management
Clinical Data ManagementMahesh Koppula
 
Quality tools (2), Ola Elgaddar, 30 09 - 2013
Quality tools (2), Ola Elgaddar, 30 09 - 2013Quality tools (2), Ola Elgaddar, 30 09 - 2013
Quality tools (2), Ola Elgaddar, 30 09 - 2013Ola Elgaddar
 
What do clinicians need to know about lab tests?
What do clinicians need to know about lab tests?What do clinicians need to know about lab tests?
What do clinicians need to know about lab tests?Ola Elgaddar
 
Leverage Your EDC Solution to Mitigate Risk in Clinical Research
Leverage Your EDC Solution to Mitigate Risk in Clinical ResearchLeverage Your EDC Solution to Mitigate Risk in Clinical Research
Leverage Your EDC Solution to Mitigate Risk in Clinical Researchwww.datatrak.com
 
Fall09 wilson
Fall09 wilsonFall09 wilson
Fall09 wilsonweb2get
 
Clinical Data Management
Clinical Data ManagementClinical Data Management
Clinical Data ManagementShray Jali
 
評量 ACGME 六大核心能力
評量 ACGME 六大核心能力評量 ACGME 六大核心能力
評量 ACGME 六大核心能力pedgishih
 
Planning And Development Of The Iss Ise Webinar Final
Planning And Development Of The Iss Ise Webinar FinalPlanning And Development Of The Iss Ise Webinar Final
Planning And Development Of The Iss Ise Webinar FinalJay1818mar
 
Clinical Data Review Best Practices - E. Herbel
Clinical Data Review Best Practices - E. HerbelClinical Data Review Best Practices - E. Herbel
Clinical Data Review Best Practices - E. HerbelQuanticate
 
Measuring the Effectiveness of eHealth Initiatives in Hospitals
Measuring the Effectiveness of eHealth Initiatives in HospitalsMeasuring the Effectiveness of eHealth Initiatives in Hospitals
Measuring the Effectiveness of eHealth Initiatives in HospitalsHealth Informatics New Zealand
 
Amia Pres Oct 26 2011 Final
Amia Pres Oct 26 2011 FinalAmia Pres Oct 26 2011 Final
Amia Pres Oct 26 2011 FinalBrad Doebbeling
 
Streamlining Data Management Start-up
Streamlining Data Management Start-upStreamlining Data Management Start-up
Streamlining Data Management Start-upjbarag
 
The impact of electronic data capture on clinical data management
The impact of electronic data capture on clinical data managementThe impact of electronic data capture on clinical data management
The impact of electronic data capture on clinical data managementClin Plus
 
Bioanalytical validation house of cards
Bioanalytical validation house of cardsBioanalytical validation house of cards
Bioanalytical validation house of cardsE. Dennis Bashaw
 
East sample size re estimation
East sample size re estimationEast sample size re estimation
East sample size re estimationCytel
 
Bike.December.2008
Bike.December.2008Bike.December.2008
Bike.December.2008giovanny builes
 
Bike photo anual
Bike photo anualBike photo anual
Bike photo anualgiovanny builes
 

More Related Content

What's hot

Clinical research and clinical data management - Ikya Global
Clinical research and clinical data management - Ikya GlobalClinical research and clinical data management - Ikya Global
Clinical research and clinical data management - Ikya Globalikya global
 
Are we using the correct quality goals?
Are we using the correct quality goals?Are we using the correct quality goals?
Are we using the correct quality goals?Ola Elgaddar
 
clinical data management
clinical data managementclinical data management
clinical data managementsopi_1234
 
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Bhaswat Chakraborty
 
causes of laboratory errors
causes of laboratory errorscauses of laboratory errors
causes of laboratory errorsShahad Bakhdar
 
Clinical Data Management
Clinical Data ManagementClinical Data Management
Clinical Data ManagementMahesh Koppula
 
Quality tools (2), Ola Elgaddar, 30 09 - 2013
Quality tools (2), Ola Elgaddar, 30 09 - 2013Quality tools (2), Ola Elgaddar, 30 09 - 2013
Quality tools (2), Ola Elgaddar, 30 09 - 2013Ola Elgaddar
 
What do clinicians need to know about lab tests?
What do clinicians need to know about lab tests?What do clinicians need to know about lab tests?
What do clinicians need to know about lab tests?Ola Elgaddar
 
Leverage Your EDC Solution to Mitigate Risk in Clinical Research
Leverage Your EDC Solution to Mitigate Risk in Clinical ResearchLeverage Your EDC Solution to Mitigate Risk in Clinical Research
Leverage Your EDC Solution to Mitigate Risk in Clinical Researchwww.datatrak.com
 
Fall09 wilson
Fall09 wilsonFall09 wilson
Fall09 wilsonweb2get
 
Clinical Data Management
Clinical Data ManagementClinical Data Management
Clinical Data ManagementShray Jali
 
評量 ACGME 六大核心能力
評量 ACGME 六大核心能力評量 ACGME 六大核心能力
評量 ACGME 六大核心能力pedgishih
 
Planning And Development Of The Iss Ise Webinar Final
Planning And Development Of The Iss Ise Webinar FinalPlanning And Development Of The Iss Ise Webinar Final
Planning And Development Of The Iss Ise Webinar FinalJay1818mar
 
Clinical Data Review Best Practices - E. Herbel
Clinical Data Review Best Practices - E. HerbelClinical Data Review Best Practices - E. Herbel
Clinical Data Review Best Practices - E. HerbelQuanticate
 
Measuring the Effectiveness of eHealth Initiatives in Hospitals
Measuring the Effectiveness of eHealth Initiatives in HospitalsMeasuring the Effectiveness of eHealth Initiatives in Hospitals
Measuring the Effectiveness of eHealth Initiatives in HospitalsHealth Informatics New Zealand
 
Amia Pres Oct 26 2011 Final
Amia Pres Oct 26 2011 FinalAmia Pres Oct 26 2011 Final
Amia Pres Oct 26 2011 FinalBrad Doebbeling
 
Streamlining Data Management Start-up
Streamlining Data Management Start-upStreamlining Data Management Start-up
Streamlining Data Management Start-upjbarag
 
The impact of electronic data capture on clinical data management
The impact of electronic data capture on clinical data managementThe impact of electronic data capture on clinical data management
The impact of electronic data capture on clinical data managementClin Plus
 
Bioanalytical validation house of cards
Bioanalytical validation house of cardsBioanalytical validation house of cards
Bioanalytical validation house of cardsE. Dennis Bashaw
 
East sample size re estimation
East sample size re estimationEast sample size re estimation
East sample size re estimationCytel
 

What's hot (20)

Clinical research and clinical data management - Ikya Global
Clinical research and clinical data management - Ikya GlobalClinical research and clinical data management - Ikya Global
Clinical research and clinical data management - Ikya Global
 
Are we using the correct quality goals?
Are we using the correct quality goals?Are we using the correct quality goals?
Are we using the correct quality goals?
 
clinical data management
clinical data managementclinical data management
clinical data management
 
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...
 
causes of laboratory errors
causes of laboratory errorscauses of laboratory errors
causes of laboratory errors
 
Clinical Data Management
Clinical Data ManagementClinical Data Management
Clinical Data Management
 
Quality tools (2), Ola Elgaddar, 30 09 - 2013
Quality tools (2), Ola Elgaddar, 30 09 - 2013Quality tools (2), Ola Elgaddar, 30 09 - 2013
Quality tools (2), Ola Elgaddar, 30 09 - 2013
 
What do clinicians need to know about lab tests?
What do clinicians need to know about lab tests?What do clinicians need to know about lab tests?
What do clinicians need to know about lab tests?
 
Leverage Your EDC Solution to Mitigate Risk in Clinical Research
Leverage Your EDC Solution to Mitigate Risk in Clinical ResearchLeverage Your EDC Solution to Mitigate Risk in Clinical Research
Leverage Your EDC Solution to Mitigate Risk in Clinical Research
 
Fall09 wilson
Fall09 wilsonFall09 wilson
Fall09 wilson
 
Clinical Data Management
Clinical Data ManagementClinical Data Management
Clinical Data Management
 
評量 ACGME 六大核心能力
評量 ACGME 六大核心能力評量 ACGME 六大核心能力
評量 ACGME 六大核心能力
 
Planning And Development Of The Iss Ise Webinar Final
Planning And Development Of The Iss Ise Webinar FinalPlanning And Development Of The Iss Ise Webinar Final
Planning And Development Of The Iss Ise Webinar Final
 
Clinical Data Review Best Practices - E. Herbel
Clinical Data Review Best Practices - E. HerbelClinical Data Review Best Practices - E. Herbel
Clinical Data Review Best Practices - E. Herbel
 
Measuring the Effectiveness of eHealth Initiatives in Hospitals
Measuring the Effectiveness of eHealth Initiatives in HospitalsMeasuring the Effectiveness of eHealth Initiatives in Hospitals
Measuring the Effectiveness of eHealth Initiatives in Hospitals
 
Amia Pres Oct 26 2011 Final
Amia Pres Oct 26 2011 FinalAmia Pres Oct 26 2011 Final
Amia Pres Oct 26 2011 Final
 
Streamlining Data Management Start-up
Streamlining Data Management Start-upStreamlining Data Management Start-up
Streamlining Data Management Start-up
 
The impact of electronic data capture on clinical data management
The impact of electronic data capture on clinical data managementThe impact of electronic data capture on clinical data management
The impact of electronic data capture on clinical data management
 
Bioanalytical validation house of cards
Bioanalytical validation house of cardsBioanalytical validation house of cards
Bioanalytical validation house of cards
 
East sample size re estimation
East sample size re estimationEast sample size re estimation
East sample size re estimation
 

Viewers also liked

Main Portfolio
Main PortfolioMain Portfolio
Main Portfoliodhermil
 
Mountain.Bike.Action.April.2009
Mountain.Bike.Action.April.2009Mountain.Bike.Action.April.2009
Mountain.Bike.Action.April.2009giovanny builes
 
mountain bike rider octubre 2009
mountain bike rider octubre 2009mountain bike rider octubre 2009
mountain bike rider octubre 2009giovanny builes
 
Mountain Bike Action 2009 09
Mountain Bike Action 2009 09Mountain Bike Action 2009 09
Mountain Bike Action 2009 09giovanny builes
 
360 Anskaffelse Og Kontrakt 12 Mai 2009
360 Anskaffelse Og Kontrakt 12 Mai 2009360 Anskaffelse Og Kontrakt 12 Mai 2009
360 Anskaffelse Og Kontrakt 12 Mai 2009SoftwareInnovation
 
Diapositivas Emmanuel Castro(Ied)
Diapositivas Emmanuel Castro(Ied)Diapositivas Emmanuel Castro(Ied)
Diapositivas Emmanuel Castro(Ied)emmanuelcastro
 
Mountain Bike Action 2009 07
Mountain Bike Action 2009 07Mountain Bike Action 2009 07
Mountain Bike Action 2009 07giovanny builes
 
Que Significa Convertirse En Persona
Que Significa Convertirse En PersonaQue Significa Convertirse En Persona
Que Significa Convertirse En Personadaviduaslp
 
Viii Simposium De Educacion Catedra
Viii Simposium De Educacion CatedraViii Simposium De Educacion Catedra
Viii Simposium De Educacion Catedradaviduaslp
 
ePro Adaptive Design
ePro Adaptive DesignePro Adaptive Design
ePro Adaptive DesignchallPHT
 
Eugm 2011 pocock - dm cs-and-adaptive-trials
Eugm 2011 pocock - dm cs-and-adaptive-trialsEugm 2011 pocock - dm cs-and-adaptive-trials
Eugm 2011 pocock - dm cs-and-adaptive-trialsCytel USA
 
D6 transforming oncology development with adaptive studies - 2011-04
D6 transforming oncology development with adaptive studies - 2011-04D6 transforming oncology development with adaptive studies - 2011-04
D6 transforming oncology development with adaptive studies - 2011-04therealreverendbayes
 

Viewers also liked (20)

Bike.December.2008
Bike.December.2008Bike.December.2008
Bike.December.2008
 
Bike photo anual
Bike photo anualBike photo anual
Bike photo anual
 
Bike Magazine noviembre
Bike Magazine noviembreBike Magazine noviembre
Bike Magazine noviembre
 
Bike magazine octubre
Bike magazine octubreBike magazine octubre
Bike magazine octubre
 
Main Portfolio
Main PortfolioMain Portfolio
Main Portfolio
 
Mountain.Bike.Action.April.2009
Mountain.Bike.Action.April.2009Mountain.Bike.Action.April.2009
Mountain.Bike.Action.April.2009
 
mountain bike rider octubre 2009
mountain bike rider octubre 2009mountain bike rider octubre 2009
mountain bike rider octubre 2009
 
Simonsen
SimonsenSimonsen
Simonsen
 
solo bici junio 2009
solo bici junio 2009solo bici junio 2009
solo bici junio 2009
 
Mountain Bike Action 2009 09
Mountain Bike Action 2009 09Mountain Bike Action 2009 09
Mountain Bike Action 2009 09
 
360 Anskaffelse Og Kontrakt 12 Mai 2009
360 Anskaffelse Og Kontrakt 12 Mai 2009360 Anskaffelse Og Kontrakt 12 Mai 2009
360 Anskaffelse Og Kontrakt 12 Mai 2009
 
Diapositivas Emmanuel Castro(Ied)
Diapositivas Emmanuel Castro(Ied)Diapositivas Emmanuel Castro(Ied)
Diapositivas Emmanuel Castro(Ied)
 
Hoja Maplet
Hoja MapletHoja Maplet
Hoja Maplet
 
Mountain Bike Action 2009 07
Mountain Bike Action 2009 07Mountain Bike Action 2009 07
Mountain Bike Action 2009 07
 
Que Significa Convertirse En Persona
Que Significa Convertirse En PersonaQue Significa Convertirse En Persona
Que Significa Convertirse En Persona
 
Road Bike Action aosto
Road Bike Action aostoRoad Bike Action aosto
Road Bike Action aosto
 
Viii Simposium De Educacion Catedra
Viii Simposium De Educacion CatedraViii Simposium De Educacion Catedra
Viii Simposium De Educacion Catedra
 
ePro Adaptive Design
ePro Adaptive DesignePro Adaptive Design
ePro Adaptive Design
 
Eugm 2011 pocock - dm cs-and-adaptive-trials
Eugm 2011 pocock - dm cs-and-adaptive-trialsEugm 2011 pocock - dm cs-and-adaptive-trials
Eugm 2011 pocock - dm cs-and-adaptive-trials
 
D6 transforming oncology development with adaptive studies - 2011-04
D6 transforming oncology development with adaptive studies - 2011-04D6 transforming oncology development with adaptive studies - 2011-04
D6 transforming oncology development with adaptive studies - 2011-04
 

Similar to Dragalin Flexible Design

Innovative Strategies For Successful Trial Design - Webinar Slides
Innovative Strategies For Successful Trial Design - Webinar SlidesInnovative Strategies For Successful Trial Design - Webinar Slides
Innovative Strategies For Successful Trial Design - Webinar SlidesnQuery
 
2020 trends in biostatistics what you should know about study design - slid...
2020 trends in biostatistics what you should know about study design - slid...2020 trends in biostatistics what you should know about study design - slid...
2020 trends in biostatistics what you should know about study design - slid...nQuery
 
Webinar slides sample size for survival analysis - a guide to planning succ...
Webinar slides sample size for survival analysis - a guide to planning succ...Webinar slides sample size for survival analysis - a guide to planning succ...
Webinar slides sample size for survival analysis - a guide to planning succ...nQuery
 
Sample size for survival analysis - a guide to planning successful clinical t...
Sample size for survival analysis - a guide to planning successful clinical t...Sample size for survival analysis - a guide to planning successful clinical t...
Sample size for survival analysis - a guide to planning successful clinical t...nQuery
 
Innovative sample size methods for adaptive clinical trials webinar web ver...
Innovative sample size methods for adaptive clinical trials webinar web ver...Innovative sample size methods for adaptive clinical trials webinar web ver...
Innovative sample size methods for adaptive clinical trials webinar web ver...nQuery
 
Optimizing Oncology Trial Design FAQs & Common Issues
Optimizing Oncology Trial Design FAQs & Common IssuesOptimizing Oncology Trial Design FAQs & Common Issues
Optimizing Oncology Trial Design FAQs & Common IssuesnQuery
 
Adaptive Clinical Trials: Role of Modelling and Simulation
Adaptive Clinical Trials: Role of Modelling and Simulation Adaptive Clinical Trials: Role of Modelling and Simulation
Adaptive Clinical Trials: Role of Modelling and Simulation SGS
 
Can the tqt study be replaced b darpo london june 2013 (2)
Can the tqt study be replaced b darpo london june 2013 (2)Can the tqt study be replaced b darpo london june 2013 (2)
Can the tqt study be replaced b darpo london june 2013 (2)Sasha Latypova
 
Redefining the Gold Standard
Redefining the Gold StandardRedefining the Gold Standard
Redefining the Gold StandardCovance
 
Adaptive Design
Adaptive DesignAdaptive Design
Adaptive Designcasiopeita
 
Adapting CDISC to Adaptive Design
Adapting CDISC to Adaptive DesignAdapting CDISC to Adaptive Design
Adapting CDISC to Adaptive DesignAngelo Tinazzi
 
Joseph Levy MedicReS World Congress 2013 - 1
Joseph Levy MedicReS World Congress 2013 - 1 Joseph Levy MedicReS World Congress 2013 - 1
Joseph Levy MedicReS World Congress 2013 - 1 MedicReS
 
Raskob Iscram 2009
Raskob Iscram 2009Raskob Iscram 2009
Raskob Iscram 2009guestee5a52
 
Overview of ePRO
Overview of ePROOverview of ePRO
Overview of ePROchallPHT
 
Extending A Trial’s Design Case Studies Of Dealing With Study Design Issues
Extending A Trial’s Design Case Studies Of Dealing With Study Design IssuesExtending A Trial’s Design Case Studies Of Dealing With Study Design Issues
Extending A Trial’s Design Case Studies Of Dealing With Study Design IssuesnQuery
 
D1 design and analysis approaches to evaluate cardiovascular risk - 2012 eugm
D1 design and analysis approaches to evaluate cardiovascular risk - 2012 eugmD1 design and analysis approaches to evaluate cardiovascular risk - 2012 eugm
D1 design and analysis approaches to evaluate cardiovascular risk - 2012 eugmtherealreverendbayes
 
Eugm 2012 gaydos - design and analysis approaches to evaluate cardiovascula...
Eugm 2012 gaydos - design and analysis approaches to evaluate cardiovascula...Eugm 2012 gaydos - design and analysis approaches to evaluate cardiovascula...
Eugm 2012 gaydos - design and analysis approaches to evaluate cardiovascula...Cytel USA
 
2012-05-30 EUGM | GAYDOS | Design & Analysis Approaches to Evaluate Cardiovas...
2012-05-30 EUGM | GAYDOS | Design & Analysis Approaches to Evaluate Cardiovas...2012-05-30 EUGM | GAYDOS | Design & Analysis Approaches to Evaluate Cardiovas...
2012-05-30 EUGM | GAYDOS | Design & Analysis Approaches to Evaluate Cardiovas...Cytel USA
 

Similar to Dragalin Flexible Design (20)

Innovative Strategies For Successful Trial Design - Webinar Slides
Innovative Strategies For Successful Trial Design - Webinar SlidesInnovative Strategies For Successful Trial Design - Webinar Slides
Innovative Strategies For Successful Trial Design - Webinar Slides
 
2020 trends in biostatistics what you should know about study design - slid...
2020 trends in biostatistics what you should know about study design - slid...2020 trends in biostatistics what you should know about study design - slid...
2020 trends in biostatistics what you should know about study design - slid...
 
Intro To Adaptive Design
Intro To Adaptive DesignIntro To Adaptive Design
Intro To Adaptive Design
 
Webinar slides sample size for survival analysis - a guide to planning succ...
Webinar slides sample size for survival analysis - a guide to planning succ...Webinar slides sample size for survival analysis - a guide to planning succ...
Webinar slides sample size for survival analysis - a guide to planning succ...
 
Sample size for survival analysis - a guide to planning successful clinical t...
Sample size for survival analysis - a guide to planning successful clinical t...Sample size for survival analysis - a guide to planning successful clinical t...
Sample size for survival analysis - a guide to planning successful clinical t...
 
Innovative sample size methods for adaptive clinical trials webinar web ver...
Innovative sample size methods for adaptive clinical trials webinar web ver...Innovative sample size methods for adaptive clinical trials webinar web ver...
Innovative sample size methods for adaptive clinical trials webinar web ver...
 
Optimizing Oncology Trial Design FAQs & Common Issues
Optimizing Oncology Trial Design FAQs & Common IssuesOptimizing Oncology Trial Design FAQs & Common Issues
Optimizing Oncology Trial Design FAQs & Common Issues
 
Adapting to Adaptive
Adapting to AdaptiveAdapting to Adaptive
Adapting to Adaptive
 
Adaptive Clinical Trials: Role of Modelling and Simulation
Adaptive Clinical Trials: Role of Modelling and Simulation Adaptive Clinical Trials: Role of Modelling and Simulation
Adaptive Clinical Trials: Role of Modelling and Simulation
 
Can the tqt study be replaced b darpo london june 2013 (2)
Can the tqt study be replaced b darpo london june 2013 (2)Can the tqt study be replaced b darpo london june 2013 (2)
Can the tqt study be replaced b darpo london june 2013 (2)
 
Redefining the Gold Standard
Redefining the Gold StandardRedefining the Gold Standard
Redefining the Gold Standard
 
Adaptive Design
Adaptive DesignAdaptive Design
Adaptive Design
 
Adapting CDISC to Adaptive Design
Adapting CDISC to Adaptive DesignAdapting CDISC to Adaptive Design
Adapting CDISC to Adaptive Design
 
Joseph Levy MedicReS World Congress 2013 - 1
Joseph Levy MedicReS World Congress 2013 - 1 Joseph Levy MedicReS World Congress 2013 - 1
Joseph Levy MedicReS World Congress 2013 - 1
 
Raskob Iscram 2009
Raskob Iscram 2009Raskob Iscram 2009
Raskob Iscram 2009
 
Overview of ePRO
Overview of ePROOverview of ePRO
Overview of ePRO
 
Extending A Trial’s Design Case Studies Of Dealing With Study Design Issues
Extending A Trial’s Design Case Studies Of Dealing With Study Design IssuesExtending A Trial’s Design Case Studies Of Dealing With Study Design Issues
Extending A Trial’s Design Case Studies Of Dealing With Study Design Issues
 
D1 design and analysis approaches to evaluate cardiovascular risk - 2012 eugm
D1 design and analysis approaches to evaluate cardiovascular risk - 2012 eugmD1 design and analysis approaches to evaluate cardiovascular risk - 2012 eugm
D1 design and analysis approaches to evaluate cardiovascular risk - 2012 eugm
 
Eugm 2012 gaydos - design and analysis approaches to evaluate cardiovascula...
Eugm 2012 gaydos - design and analysis approaches to evaluate cardiovascula...Eugm 2012 gaydos - design and analysis approaches to evaluate cardiovascula...
Eugm 2012 gaydos - design and analysis approaches to evaluate cardiovascula...
 
2012-05-30 EUGM | GAYDOS | Design & Analysis Approaches to Evaluate Cardiovas...
2012-05-30 EUGM | GAYDOS | Design & Analysis Approaches to Evaluate Cardiovas...2012-05-30 EUGM | GAYDOS | Design & Analysis Approaches to Evaluate Cardiovas...
2012-05-30 EUGM | GAYDOS | Design & Analysis Approaches to Evaluate Cardiovas...
 

Recently uploaded

Call Girls In Kishangarh Delhi ❤️8860477959 Good Looking Escorts In 24/7 Delh...
Call Girls In Kishangarh Delhi ❤️8860477959 Good Looking Escorts In 24/7 Delh...Call Girls In Kishangarh Delhi ❤️8860477959 Good Looking Escorts In 24/7 Delh...
Call Girls In Kishangarh Delhi ❤️8860477959 Good Looking Escorts In 24/7 Delh...lizamodels9
 
A.I. Bot Summit 3 Opening Keynote - Perry Belcher
A.I. Bot Summit 3 Opening Keynote - Perry BelcherA.I. Bot Summit 3 Opening Keynote - Perry Belcher
A.I. Bot Summit 3 Opening Keynote - Perry BelcherPerry Belcher
 
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With Room
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With RoomVIP Kolkata Call Girl Howrah 👉 8250192130 Available With Room
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With Roomdivyansh0kumar0
 
BEST Call Girls In BELLMONT HOTEL ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,
BEST Call Girls In BELLMONT HOTEL ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,BEST Call Girls In BELLMONT HOTEL ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,
BEST Call Girls In BELLMONT HOTEL ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,noida100girls
 
(8264348440) 🔝 Call Girls In Hauz Khas 🔝 Delhi NCR
(8264348440) 🔝 Call Girls In Hauz Khas 🔝 Delhi NCR(8264348440) 🔝 Call Girls In Hauz Khas 🔝 Delhi NCR
(8264348440) 🔝 Call Girls In Hauz Khas 🔝 Delhi NCRsoniya singh
 
Sales & Marketing Alignment: How to Synergize for Success
Sales & Marketing Alignment: How to Synergize for SuccessSales & Marketing Alignment: How to Synergize for Success
Sales & Marketing Alignment: How to Synergize for SuccessAggregage
 
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...lizamodels9
 
Call Girls in Mehrauli Delhi 💯Call Us 🔝8264348440🔝
Call Girls in Mehrauli Delhi 💯Call Us 🔝8264348440🔝Call Girls in Mehrauli Delhi 💯Call Us 🔝8264348440🔝
Call Girls in Mehrauli Delhi 💯Call Us 🔝8264348440🔝soniya singh
 
(8264348440) 🔝 Call Girls In Keshav Puram 🔝 Delhi NCR
(8264348440) 🔝 Call Girls In Keshav Puram 🔝 Delhi NCR(8264348440) 🔝 Call Girls In Keshav Puram 🔝 Delhi NCR
(8264348440) 🔝 Call Girls In Keshav Puram 🔝 Delhi NCRsoniya singh
 
Call Girls In Connaught Place Delhi ❤️88604**77959_Russian 100% Genuine Escor...
Call Girls In Connaught Place Delhi ❤️88604**77959_Russian 100% Genuine Escor...Call Girls In Connaught Place Delhi ❤️88604**77959_Russian 100% Genuine Escor...
Call Girls In Connaught Place Delhi ❤️88604**77959_Russian 100% Genuine Escor...lizamodels9
 
Vip Female Escorts Noida 9711199171 Greater Noida Escorts Service
Vip Female Escorts Noida 9711199171 Greater Noida Escorts ServiceVip Female Escorts Noida 9711199171 Greater Noida Escorts Service
Vip Female Escorts Noida 9711199171 Greater Noida Escorts Serviceankitnayak356677
 
Keppel Ltd. 1Q 2024 Business Update Presentation Slides
Keppel Ltd. 1Q 2024 Business Update Presentation SlidesKeppel Ltd. 1Q 2024 Business Update Presentation Slides
Keppel Ltd. 1Q 2024 Business Update Presentation SlidesKeppelCorporation
 
The CMO Survey - Highlights and Insights Report - Spring 2024
The CMO Survey - Highlights and Insights Report - Spring 2024The CMO Survey - Highlights and Insights Report - Spring 2024
The CMO Survey - Highlights and Insights Report - Spring 2024christinemoorman
 
BEST Call Girls In Old Faridabad ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,
BEST Call Girls In Old Faridabad ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,BEST Call Girls In Old Faridabad ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,
BEST Call Girls In Old Faridabad ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,noida100girls
 
Banana Powder Manufacturing Plant Project Report 2024 Edition.pptx
Banana Powder Manufacturing Plant Project Report 2024 Edition.pptxBanana Powder Manufacturing Plant Project Report 2024 Edition.pptx
Banana Powder Manufacturing Plant Project Report 2024 Edition.pptxgeorgebrinton95
 
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...lizamodels9
 
2024 Numerator Consumer Study of Cannabis Usage
2024 Numerator Consumer Study of Cannabis Usage2024 Numerator Consumer Study of Cannabis Usage
2024 Numerator Consumer Study of Cannabis UsageNeil Kimberley
 
RE Capital's Visionary Leadership under Newman Leech
RE Capital's Visionary Leadership under Newman LeechRE Capital's Visionary Leadership under Newman Leech
RE Capital's Visionary Leadership under Newman LeechNewman George Leech
 
Lowrate Call Girls In Laxmi Nagar Delhi ❤️8860477959 Escorts 100% Genuine Ser...
Lowrate Call Girls In Laxmi Nagar Delhi ❤️8860477959 Escorts 100% Genuine Ser...Lowrate Call Girls In Laxmi Nagar Delhi ❤️8860477959 Escorts 100% Genuine Ser...
Lowrate Call Girls In Laxmi Nagar Delhi ❤️8860477959 Escorts 100% Genuine Ser...lizamodels9
 

Recently uploaded (20)

Call Girls In Kishangarh Delhi ❤️8860477959 Good Looking Escorts In 24/7 Delh...
Call Girls In Kishangarh Delhi ❤️8860477959 Good Looking Escorts In 24/7 Delh...Call Girls In Kishangarh Delhi ❤️8860477959 Good Looking Escorts In 24/7 Delh...
Call Girls In Kishangarh Delhi ❤️8860477959 Good Looking Escorts In 24/7 Delh...
 
A.I. Bot Summit 3 Opening Keynote - Perry Belcher
A.I. Bot Summit 3 Opening Keynote - Perry BelcherA.I. Bot Summit 3 Opening Keynote - Perry Belcher
A.I. Bot Summit 3 Opening Keynote - Perry Belcher
 
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With Room
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With RoomVIP Kolkata Call Girl Howrah 👉 8250192130 Available With Room
VIP Kolkata Call Girl Howrah 👉 8250192130 Available With Room
 
BEST Call Girls In BELLMONT HOTEL ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,
BEST Call Girls In BELLMONT HOTEL ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,BEST Call Girls In BELLMONT HOTEL ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,
BEST Call Girls In BELLMONT HOTEL ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,
 
(8264348440) 🔝 Call Girls In Hauz Khas 🔝 Delhi NCR
(8264348440) 🔝 Call Girls In Hauz Khas 🔝 Delhi NCR(8264348440) 🔝 Call Girls In Hauz Khas 🔝 Delhi NCR
(8264348440) 🔝 Call Girls In Hauz Khas 🔝 Delhi NCR
 
Sales & Marketing Alignment: How to Synergize for Success
Sales & Marketing Alignment: How to Synergize for SuccessSales & Marketing Alignment: How to Synergize for Success
Sales & Marketing Alignment: How to Synergize for Success
 
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...
 
Call Girls in Mehrauli Delhi 💯Call Us 🔝8264348440🔝
Call Girls in Mehrauli Delhi 💯Call Us 🔝8264348440🔝Call Girls in Mehrauli Delhi 💯Call Us 🔝8264348440🔝
Call Girls in Mehrauli Delhi 💯Call Us 🔝8264348440🔝
 
(8264348440) 🔝 Call Girls In Keshav Puram 🔝 Delhi NCR
(8264348440) 🔝 Call Girls In Keshav Puram 🔝 Delhi NCR(8264348440) 🔝 Call Girls In Keshav Puram 🔝 Delhi NCR
(8264348440) 🔝 Call Girls In Keshav Puram 🔝 Delhi NCR
 
Call Girls In Connaught Place Delhi ❤️88604**77959_Russian 100% Genuine Escor...
Call Girls In Connaught Place Delhi ❤️88604**77959_Russian 100% Genuine Escor...Call Girls In Connaught Place Delhi ❤️88604**77959_Russian 100% Genuine Escor...
Call Girls In Connaught Place Delhi ❤️88604**77959_Russian 100% Genuine Escor...
 
Vip Female Escorts Noida 9711199171 Greater Noida Escorts Service
Vip Female Escorts Noida 9711199171 Greater Noida Escorts ServiceVip Female Escorts Noida 9711199171 Greater Noida Escorts Service
Vip Female Escorts Noida 9711199171 Greater Noida Escorts Service
 
Keppel Ltd. 1Q 2024 Business Update Presentation Slides
Keppel Ltd. 1Q 2024 Business Update Presentation SlidesKeppel Ltd. 1Q 2024 Business Update Presentation Slides
Keppel Ltd. 1Q 2024 Business Update Presentation Slides
 
The CMO Survey - Highlights and Insights Report - Spring 2024
The CMO Survey - Highlights and Insights Report - Spring 2024The CMO Survey - Highlights and Insights Report - Spring 2024
The CMO Survey - Highlights and Insights Report - Spring 2024
 
BEST Call Girls In Old Faridabad ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,
BEST Call Girls In Old Faridabad ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,BEST Call Girls In Old Faridabad ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,
BEST Call Girls In Old Faridabad ✨ 9773824855 ✨ Escorts Service In Delhi Ncr,
 
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCREnjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
 
Banana Powder Manufacturing Plant Project Report 2024 Edition.pptx
Banana Powder Manufacturing Plant Project Report 2024 Edition.pptxBanana Powder Manufacturing Plant Project Report 2024 Edition.pptx
Banana Powder Manufacturing Plant Project Report 2024 Edition.pptx
 
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...
Call Girls In Sikandarpur Gurgaon ❤️8860477959_Russian 100% Genuine Escorts I...
 
2024 Numerator Consumer Study of Cannabis Usage
2024 Numerator Consumer Study of Cannabis Usage2024 Numerator Consumer Study of Cannabis Usage
2024 Numerator Consumer Study of Cannabis Usage
 
RE Capital's Visionary Leadership under Newman Leech
RE Capital's Visionary Leadership under Newman LeechRE Capital's Visionary Leadership under Newman Leech
RE Capital's Visionary Leadership under Newman Leech
 
Lowrate Call Girls In Laxmi Nagar Delhi ❤️8860477959 Escorts 100% Genuine Ser...
Lowrate Call Girls In Laxmi Nagar Delhi ❤️8860477959 Escorts 100% Genuine Ser...Lowrate Call Girls In Laxmi Nagar Delhi ❤️8860477959 Escorts 100% Genuine Ser...
Lowrate Call Girls In Laxmi Nagar Delhi ❤️8860477959 Escorts 100% Genuine Ser...
 

Dragalin Flexible Design

  • 1. Flexible designs for pivotal clinical trials Vlad Dragalin, RSU-SDS-BDS-GSK FDA/Industry Workshop Session: Flexible Designs – Are We Ready Yet? Washington, D.C., September 14-16, 2005
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7. Adaptive Design Process Decision Rule New Patient Sampling Rule Stopping Rule Allocation Rule Data
  • 8.
  • 9.
  • 10.
  • 11.
  • 12. Details of the Design Primary Endpoint: Primary Goal: Target Difference: STDeviation: Type I error: Power: Traditional Dsgn: Adaptive Dsgn: Efficacy Bndry: Futility Bndry: Inflation Factor: PI-NRS change from Baseline at 8 th W of treatment Comparison of three SBx doses (LD, MD, HD) with Plb 1.3 units 2.1 units  = 0.05 (adjustment for multiplicity  = 0.05/3 = 0.017) 90% 4 parallel groups - 72 patients/per arm (total 288) 3 stage inverse-normal combination test O’Brien-Fleming type nominal levels: (0.0006, 0.014, 0.0235) nominal levels: (0.5, 0.5) 1.025 - maximum 75 patients/arm
  • 13.
  • 14.
  • 15.
  • 16. Interim Analyses: Data For each arm at each stage
  • 17. Interim Analyses: Test Null Hypothesis: Estimate of mean 8 th W endpoint: Standardized Test Statistics: Reduced Variance:
  • 18.
  • 19. Design Properties Parallel 4 arm Dsgn: 72 per arm
  • 20.
  • 21.