Literature DB >> 29698104

Bias, Operational Bias, and Generalizability in Phase II/III Trials.

Boris Freidlin1, Edward L Korn1, Jeffrey S Abrams1.   

Abstract

Mesh：

Year:  2018        PMID： 29698104      PMCID： PMC6075858          DOI： 10.1200/JCO.2017.77.0479

Source DB:  PubMed          Journal:  J Clin Oncol        ISSN： 0732-183X            Impact factor:   44.544


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  13 in total

1.  Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections, by H. Schäfer and H.-H. Müller, Statistics in Medicine 2001; 20: 3741-3751.

Authors:  P Bauer; M Posch
Journal:  Stat Med       Date:  2004-04-30       Impact factor: 2.373

2.  Adaptive methods: telling "the rest of the story".

Authors:  Scott S Emerson; Thomas R Fleming
Journal:  J Biopharm Stat       Date:  2010-11       Impact factor: 1.051

3.  Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts.

Authors:  Frank Bretz; Heinz Schmidli; Franz König; Amy Racine; Willi Maurer
Journal:  Biom J       Date:  2006-08       Impact factor: 2.207

4.  Stopping at nothing? Some dilemmas of data monitoring in clinical trials.

Authors:  Steven N Goodman
Journal:  Ann Intern Med       Date:  2007-06-19       Impact factor: 25.391

5.  Stopping clinical trials early for benefit: impact on estimation.

Authors:  Boris Freidlin; Edward L Korn
Journal:  Clin Trials       Date:  2009-04       Impact factor: 2.486

6.  When is a seamless study desirable? Case studies from different pharmaceutical sponsors.

Authors:  Robert L Cuffe; David Lawrence; Andrew Stone; Marc Vandemeulebroecke
Journal:  Pharm Stat       Date:  2014-05-29       Impact factor: 1.894

7.  Outcome--adaptive randomization: is it useful?

Authors:  Edward L Korn; Boris Freidlin
Journal:  J Clin Oncol       Date:  2010-12-20       Impact factor: 44.544

8.  Modeling the relationship between progression-free survival and overall survival: the phase II/III trial.

Authors:  Mary W Redman; Bryan H Goldman; Michael LeBlanc; Anne Schott; Laurence H Baker
Journal:  Clin Cancer Res       Date:  2013-05-15       Impact factor: 12.531

Review 9.  Integrated phase II/III clinical trials in oncology: a case study.

Authors:  Meihua Wang; James J Dignam; Qiang E Zhang; John F DeGroot; Minesh P Mehta; Sally Hunsberger
Journal:  Clin Trials       Date:  2012-11-22       Impact factor: 2.486

10.  Sample Size Reassessment and Hypothesis Testing in Adaptive Survival Trials.

Authors:  Dominic Magirr; Thomas Jaki; Franz Koenig; Martin Posch
Journal:  PLoS One       Date:  2016-02-10       Impact factor: 3.240
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  1 in total

1.  The effects of releasing early results from ongoing clinical trials.

Authors:  Steffen Ventz; Sergio Bacallado; Rifaquat Rahman; Sara Tolaney; Jonathan D Schoenfeld; Brian M Alexander; Lorenzo Trippa
Journal:  Nat Commun       Date:  2021-02-05       Impact factor: 14.919
  1 in total

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