A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information

Nigel Stallard

doi:10.1002/sim.3863

A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information

Statistics in Medicine ◽

10.1002/sim.3863 ◽

2010 ◽

Vol 29 (9) ◽

pp. 959-971 ◽

Cited By ~ 30

Author(s):

Nigel Stallard

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Trial Design ◽

Clinical Trial Design ◽

Short Term

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An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information

Trials ◽

10.1186/1745-6215-12-s1-a2 ◽

2011 ◽

Vol 12 (S1) ◽

Author(s):

Nigel Stallard

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Trial Design ◽

Clinical Trial Design ◽

Short Term

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Extending the two‐stage single arm phase II clinical trial design to the delayed response scenario

Pharmaceutical Statistics ◽

10.1002/pst.2171 ◽

2021 ◽

Author(s):

Bo Chen ◽

Xing Zhao ◽

Juying Zhang

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Trial Design ◽

Clinical Trial Design ◽

Phase Ii Clinical Trial ◽

Delayed Response ◽

Two Stage

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P3-037: CLINICAL TRIAL DESIGN FOR A PHASE II, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF AMX0035 IN ALZHEIMER'S DISEASE

Alzheimer s & Dementia ◽

10.1016/j.jalz.2018.06.1392 ◽

2006 ◽

Vol 14 (7S_Part_20) ◽

pp. P1078-P1079

Author(s):

Kent L. Leslie ◽

Joshua Cohen ◽

Justin Klee ◽

Victoria Williams ◽

Steven E. Arnold

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Clinical Trial ◽

Phase Ii ◽

Trial Design ◽

Controlled Trial ◽

Clinical Trial Design

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Phase II Clinical Trial Design: Methods in Translational Research from the Genitourinary Committee at the Eastern Cooperative Oncology Group: Table 1.

Clinical Cancer Research ◽

10.1158/1078-0432.ccr-05-1136 ◽

2006 ◽

Vol 12 (7) ◽

pp. 1966-1969 ◽

Cited By ~ 27

Author(s):

Robert Gray ◽

Judith Manola ◽

Scott Saxman ◽

John Wright ◽

Jan Dutcher ◽

...

Keyword(s):

Clinical Trial ◽

Translational Research ◽

Phase Ii ◽

Trial Design ◽

Eastern Cooperative Oncology Group ◽

Clinical Trial Design ◽

Design Methods ◽

Phase Ii Clinical Trial ◽

Oncology Group

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The effects of heterogeneity on Simon Phase II clinical trial design operating characteristics

Open Access Journal of Clinical Trials ◽

10.2147/oajct.s10470 ◽

2010 ◽

pp. 107 ◽

Cited By ~ 2

Author(s):

Christopher Barnes

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Trial Design ◽

Clinical Trial Design ◽

Phase Ii Clinical Trial ◽

Operating Characteristics

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Biomarker-based Bayesian randomized phase II clinical trial design to identify a sensitive patient subpopulation

Statistics in Medicine ◽

10.1002/sim.6209 ◽

2014 ◽

Vol 33 (23) ◽

pp. 4008-4016 ◽

Cited By ~ 6

Author(s):

Satoshi Morita ◽

Hideharu Yamamoto ◽

Yasuo Sugitani

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Trial Design ◽

Clinical Trial Design ◽

Phase Ii Clinical Trial ◽

Randomized Phase Ii

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A two‐stage phase II clinical trial design with nested criteria for early stopping and efficacy

Pharmaceutical Statistics ◽

10.1002/pst.1965 ◽

2019 ◽

Vol 18 (6) ◽

pp. 700-713

Author(s):

Michelle DeVeaux ◽

Michael Kane ◽

Wei Wei ◽

Daniel Zelterman

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Trial Design ◽

Clinical Trial Design ◽

Phase Ii Clinical Trial ◽

Early Stopping ◽

Two Stage

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Operating characteristics of a Simon two-stage phase II clinical trial design incorporating continuous toxicity monitoring

Pharmaceutical Statistics ◽

10.1002/pst.510 ◽

2012 ◽

Vol 11 (2) ◽

pp. 170-176 ◽

Cited By ~ 4

Author(s):

H.E. Ray ◽

S.N. Rai

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Trial Design ◽

Clinical Trial Design ◽

Phase Ii Clinical Trial ◽

Operating Characteristics ◽

Two Stage ◽

Toxicity Monitoring

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An Adaptive, Phase II, Dose-Finding Clinical Trial Design to Evaluate L-Carnitine in the Treatment of Septic Shock Based on Efficacy and Predictive Probability of Subsequent Phase III Success

Critical Care Medicine ◽

10.1097/ccm.0b013e318287f850 ◽

2013 ◽

Vol 41 (7) ◽

pp. 1674-1678 ◽

Cited By ~ 22

Author(s):

Roger J. Lewis ◽

Kert Viele ◽

Kristine Broglio ◽

Scott M. Berry ◽

Alan E. Jones

Keyword(s):

Clinical Trial ◽

Septic Shock ◽

Phase Ii ◽

Trial Design ◽

Clinical Trial Design ◽

Dose Finding ◽

Phase Iii ◽

Predictive Probability ◽

Subsequent Phase

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A Bayesian-frequentist two-stage single-arm phase II clinical trial design

Statistics in Medicine ◽

10.1002/sim.5330 ◽

2012 ◽

Vol 31 (19) ◽

pp. 2055-2067 ◽

Cited By ~ 14

Author(s):

Gaohong Dong ◽

Weichung Joe Shih ◽

Dirk Moore ◽

Hui Quan ◽

Stephen Marcella

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Trial Design ◽

Clinical Trial Design ◽

Phase Ii Clinical Trial ◽

Two Stage

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