Literature DB >> 28670507

Adaptive Clinical Trials: Overview of Early-Phase Designs and Challenges.

Olga Marchenko1, Valerii Fedorov2, J Jack Lee3, Christy Nolan4, José Pinheiro5.   

Abstract

In this paper, we describe developments in adaptive design methodology and discuss implementation strategies and operational challenges in early phase adaptive clinical trials. The BATTLE trial - the first completed, biomarker-based, Bayesian adaptive randomized study in lung cancer - is presented as a case study to illustrate main ideas and share learnings.

Entities:  

Keywords:  Adaptive design; clinical trial management; data monitoring committee; early phase designs; modeling and simulation

Year:  2013        PMID： 28670507      PMCID： PMC5489916          DOI： 10.1177/2168479013513889

Source DB:  PubMed          Journal:  Ther Innov Regul Sci        ISSN： 2168-4790            Impact factor:   1.778


  44 in total

Review 1.  Adaptive randomization for clinical trials.

Authors:  William F Rosenberger; Oleksandr Sverdlov; Feifang Hu
Journal:  J Biopharm Stat       Date:  2012       Impact factor: 1.051

2.  A new BATTLE in the evolving war on cancer.

Authors:  Lecia V Sequist; Alona Muzikansky; Jeffrey A Engelman
Journal:  Cancer Discov       Date:  2011-06-01       Impact factor: 39.397

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

Authors:  Nigel Stallard
Journal:  Stat Med       Date:  2010-02-26       Impact factor: 2.373

4.  Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes.

Authors:  P F Thall; R M Simon; E H Estey
Journal:  Stat Med       Date:  1995-02-28       Impact factor: 2.373

Review 5.  Bayesian clinical trials in action.

Authors:  J Jack Lee; Caleb T Chu
Journal:  Stat Med       Date:  2012-06-18       Impact factor: 2.373

6.  Disease control rate at 8 weeks predicts clinical benefit in advanced non-small-cell lung cancer: results from Southwest Oncology Group randomized trials.

Authors:  Primo N Lara; Mary W Redman; Karen Kelly; Martin J Edelman; Stephen K Williamson; John J Crowley; David R Gandara
Journal:  J Clin Oncol       Date:  2008-01-20       Impact factor: 44.544

7.  Feasibility of image-guided transthoracic core-needle biopsy in the BATTLE lung trial.

Authors:  Alda L Tam; Edward S Kim; J Jack Lee; Joe E Ensor; Marshall E Hicks; Ximing Tang; George R Blumenschein; Christine M Alden; Jeremy J Erasmus; Anne Tsao; Scott M Lippman; Waun K Hong; Ignacio I Wistuba; Sanjay Gupta
Journal:  J Thorac Oncol       Date:  2013-04       Impact factor: 15.609

8.  Cancer phase I clinical trials: efficient dose escalation with overdose control.

Authors:  J Babb; A Rogatko; S Zacks
Journal:  Stat Med       Date:  1998-05-30       Impact factor: 2.373

9.  Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset.

Authors:  Sue-Jane Wang; Robert T O'Neill; H M James Hung
Journal:  Pharm Stat       Date:  2007 Jul-Sep       Impact factor: 1.894

10.  The BATTLE trial: personalizing therapy for lung cancer.

Authors:  Edward S Kim; Roy S Herbst; Ignacio I Wistuba; J Jack Lee; George R Blumenschein; Anne Tsao; David J Stewart; Marshall E Hicks; Jeremy Erasmus; Sanjay Gupta; Christine M Alden; Suyu Liu; Ximing Tang; Fadlo R Khuri; Hai T Tran; Bruce E Johnson; John V Heymach; Li Mao; Frank Fossella; Merrill S Kies; Vassiliki Papadimitrakopoulou; Suzanne E Davis; Scott M Lippman; Waun K Hong
Journal:  Cancer Discov       Date:  2011-06-01       Impact factor: 39.397
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  1 in total

Review 1.  Statistical controversies in clinical research: basket trials, umbrella trials, and other master protocols: a review and examples.

Authors:  L A Renfro; D J Sargent
Journal:  Ann Oncol       Date:  2017-01-01       Impact factor: 32.976
  1 in total

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