Literature DB >> 22679178

How to develop treatments for biologically heterogeneous "diseases".

Richard M Simon1.   

Abstract

The standard paradigm for the design of phase III clinical trials is not suitable for evaluation of molecularly targeted treatments in biologically heterogeneous groups of patients. Here, we comment on alternative clinical trial designs and propose a prospective discovery/evaluation framework for using tumor genomics in the design of phase III trials.

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Year:  2012        PMID： 22679178      PMCID： PMC4135717          DOI： 10.1158/1078-0432.CCR-12-1586

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN： 1078-0432            Impact factor:   12.531


  11 in total

1.  Clinical trials for predictive medicine: new challenges and paradigms.

Authors:  Richard Simon
Journal:  Clin Trials       Date:  2010-03-25       Impact factor: 2.486

2.  Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients.

Authors:  Boris Freidlin; Richard Simon
Journal:  Clin Cancer Res       Date:  2005-11-01       Impact factor: 12.531

3.  Evaluating the efficiency of targeted designs for randomized clinical trials.

Authors:  Richard Simon; Aboubakar Maitournam
Journal:  Clin Cancer Res       Date:  2004-10-15       Impact factor: 12.531

4.  How much is life worth: cetuximab, non-small cell lung cancer, and the $440 billion question.

Authors:  Tito Fojo; Christine Grady
Journal:  J Natl Cancer Inst       Date:  2009-06-29       Impact factor: 13.506

Review 5.  The use of genomics in clinical trial design.

Authors:  Richard Simon
Journal:  Clin Cancer Res       Date:  2008-10-01       Impact factor: 12.531

6.  Use of archived specimens in evaluation of prognostic and predictive biomarkers.

Authors:  Richard M Simon; Soonmyung Paik; Daniel F Hayes
Journal:  J Natl Cancer Inst       Date:  2009-10-08       Impact factor: 13.506

7.  Adaptive clinical trial designs for simultaneous testing of matched diagnostics and therapeutics.

Authors:  Howard I Scher; Shelley Fuld Nasso; Eric H Rubin; Richard Simon
Journal:  Clin Cancer Res       Date:  2011-11-01       Impact factor: 12.531

8.  A two-stage Bayesian design for co-development of new drugs and companion diagnostics.

Authors:  Stella Wanjugu Karuri; Richard Simon
Journal:  Stat Med       Date:  2012-01-11       Impact factor: 2.373

9.  Estimating the order of mutations during tumorigenesis from tumor genome sequencing data.

Authors:  Ahrim Youn; Richard Simon
Journal:  Bioinformatics       Date:  2012-04-06       Impact factor: 6.937

10.  The cross-validated adaptive signature design.

Authors:  Boris Freidlin; Wenyu Jiang; Richard Simon
Journal:  Clin Cancer Res       Date:  2010-01-12       Impact factor: 12.531
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