Literature DB >> 21351287

Extended model-based designs for more complex dose-finding studies.

John O'Quigley1, Mark Conaway.   

Abstract

We discuss extensions of model-based designs, such as the continual reassessment method, for use in dose-finding studies. Rather than work with a single model to carry out the design and analysis of a dose-finding study we indicate how the use of several models can greatly increase flexibility. We can appeal to established results on Bayesian model choice and this device makes the inferential problem essentially straightforward. The greater flexibility enables us to take on board many different kinds of added complexity. Examples include extended models to deal with subject heterogeneity, extended models to take account of different treatment schedules and extended models to tackle the problem of partial ordering.
Copyright © 2011 John Wiley & Sons, Ltd.

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Year:  2011        PMID: 21351287      PMCID: PMC3480175          DOI: 10.1002/sim.4024

Source DB:  PubMed          Journal:  Stat Med        ISSN: 0277-6715            Impact factor:   2.373


  9 in total

1.  A simple technique to evaluate model sensitivity in the continual reassessment method.

Authors:  Ying Kuen Cheung; Rick Chappell
Journal:  Biometrics       Date:  2002-09       Impact factor: 2.571

2.  Designs for single- or multiple-agent phase I trials.

Authors:  Mark R Conaway; Stephanie Dunbar; Shyamal D Peddada
Journal:  Biometrics       Date:  2004-09       Impact factor: 2.571

3.  Retrospective robustness of the continual reassessment method.

Authors:  John O'Quigley; Sarah Zohar
Journal:  J Biopharm Stat       Date:  2010-09       Impact factor: 1.051

4.  Continual reassessment method: a likelihood approach.

Authors:  J O'Quigley; L Z Shen
Journal:  Biometrics       Date:  1996-06       Impact factor: 2.571

5.  Continual reassessment method: a practical design for phase 1 clinical trials in cancer.

Authors:  J O'Quigley; M Pepe; L Fisher
Journal:  Biometrics       Date:  1990-03       Impact factor: 2.571

6.  Two-sample continual reassessment method.

Authors:  J O'Quigley; L Z Shen; A Gamst
Journal:  J Biopharm Stat       Date:  1999-03       Impact factor: 1.051

7.  Phase I dose-finding and pharmacokinetic study of paclitaxel and carboplatin with oral valspodar in patients with advanced solid tumors.

Authors:  A Patnaik; E Warner; M Michael; M J Egorin; M J Moore; L L Siu; P M Fracasso; S Rivkin; I Kerr; M Litchman; A M Oza
Journal:  J Clin Oncol       Date:  2000-11-01       Impact factor: 44.544

8.  Continual reassessment method for ordered groups.

Authors:  John O'Quigley; Xavier Paoletti
Journal:  Biometrics       Date:  2003-06       Impact factor: 2.571

9.  Model calibration in the continual reassessment method.

Authors:  Shing M Lee
Journal:  Clin Trials       Date:  2009-06       Impact factor: 2.486

  9 in total
  11 in total

Review 1.  The changing landscape of phase I trials in oncology.

Authors:  Kit Man Wong; Anna Capasso; S Gail Eckhardt
Journal:  Nat Rev Clin Oncol       Date:  2015-11-10       Impact factor: 66.675

2.  Flexible Phase I-II design for partially ordered regimens with application to therapeutic cancer vaccines.

Authors:  Nolan A Wages; Craig L Slingluff
Journal:  Stat Biosci       Date:  2019-06-04

3.  Design considerations for dose-expansion cohorts in phase I trials.

Authors:  Alexia Iasonos; John O'Quigley
Journal:  J Clin Oncol       Date:  2013-10-07       Impact factor: 44.544

4.  A Phase I/II adaptive design to determine the optimal treatment regimen from a set of combination immunotherapies in high-risk melanoma.

Authors:  Nolan A Wages; Craig L Slingluff; Gina R Petroni
Journal:  Contemp Clin Trials       Date:  2015-01-29       Impact factor: 2.226

Review 5.  Implementation of adaptive methods in early-phase clinical trials.

Authors:  Gina R Petroni; Nolan A Wages; Gautier Paux; Frédéric Dubois
Journal:  Stat Med       Date:  2016-02-29       Impact factor: 2.373

6.  Seamless Phase I/II Adaptive Design for Oncology Trials of Molecularly Targeted Agents.

Authors:  Nolan A Wages; Christopher Tait
Journal:  J Biopharm Stat       Date:  2014-06-06       Impact factor: 1.051

7.  A Phase I/II adaptive design for heterogeneous groups with application to a stereotactic body radiation therapy trial.

Authors:  Nolan A Wages; Paul W Read; Gina R Petroni
Journal:  Pharm Stat       Date:  2015-05-11       Impact factor: 1.894

8.  The Impact of Early-Phase Trial Design in the Drug Development Process.

Authors:  Mark R Conaway; Gina R Petroni
Journal:  Clin Cancer Res       Date:  2018-10-16       Impact factor: 12.531

9.  Phase I/II adaptive design for drug combination oncology trials.

Authors:  Nolan A Wages; Mark R Conaway
Journal:  Stat Med       Date:  2014-01-28       Impact factor: 2.373

10.  Shift models for dose-finding in partially ordered groups.

Authors:  Bethany Jablonski Horton; Nolan A Wages; Mark R Conaway
Journal:  Clin Trials       Date:  2018-10-11       Impact factor: 2.486

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