Warning: Undefined array key "mm" in /www/wwwroot/www.ai-bt.com/si.php on line 10 Deprecated: trim(): Passing null to parameter #1 ($string) of type string is deprecated in /www/wwwroot/www.ai-bt.com/si.php on line 10 Adjusting for misclassification in a stratified biomarker clinical trial.

Literature DB >> 24733510

Adjusting for misclassification in a stratified biomarker clinical trial.

Chunling Liu¹, Aiyi Liu, Jiang Hu, Vivian Yuan, Susan Halabi.

Abstract

Clinical trials utilizing predictive biomarkers have become a research focus in personalized medicine. We investigate the effects of biomarker misclassification on the design and analysis of stratified biomarker clinical trials. For a variety of inference problems including marker-treatment interaction in particular, we show that marker misclassification may have profound adverse effects on the coverage of confidence intervals, power of the tests, and required sample sizes. For each inferential problem, we propose methods to adjust for the classification errors.

Entities: CellLine Chemical Disease Gene Species

Keywords: biomarkers; classification error; correction for error; personalized medicine; power and sample size; prevalence; randomized controlled clinical trials; sensitivity and specificity

Mesh：

Substances：

Year: 2014 PMID： 24733510 PMCID： PMC4107031 DOI： 10.1002/sim.6164

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

18 in total

1. Estimation of genotype error rate using samples with pedigree information--an application on the GeneChip Mapping 10K array.

Authors: Ke Hao; Cheng Li; Carsten Rosenow; Wing Hung Wong
Journal: Genomics Date: 2004-10 Impact factor: 5.736

2. The retinoblastoma tumor suppressor controls androgen signaling and human prostate cancer progression.

Authors: Ankur Sharma; Wen-Shuz Yeow; Adam Ertel; Ilsa Coleman; Nigel Clegg; Chellappagounder Thangavel; Colm Morrissey; Xiaotun Zhang; Clay E S Comstock; Agnieszka K Witkiewicz; Leonard Gomella; Erik S Knudsen; Peter S Nelson; Karen E Knudsen
Journal: J Clin Invest Date: 2010-11-22 Impact factor: 14.808

3. Innovative Clinical Trial Designs: Toward a 21st-Century Health Care System.

Authors: Tze L Lai; Philip W Lavori
Journal: Stat Biosci Date: 2011-12

4. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma.

Authors: Robert J Motzer; Thomas E Hutson; Piotr Tomczak; M Dror Michaelson; Ronald M Bukowski; Olivier Rixe; Stéphane Oudard; Sylvie Negrier; Cezary Szczylik; Sindy T Kim; Isan Chen; Paul W Bycott; Charles M Baum; Robert A Figlin
Journal: N Engl J Med Date: 2007-01-11 Impact factor: 91.245

5. On the efficiency of targeted clinical trials.

Authors: A Maitournam; R Simon
Journal: Stat Med Date: 2005-02-15 Impact factor: 2.373

6. Prospective alpha allocation in the Clarification of Optimal Anticoagulation through Genetics (COAG) trial.

Authors: Jungnam Joo; Nancy L Geller; Benjamin French; Stephen E Kimmel; Yves Rosenberg; Jonas H Ellenberg
Journal: Clin Trials Date: 2010-08-06 Impact factor: 2.486

7. Prognostic or predictive plasma cytokines and angiogenic factors for patients treated with pazopanib for metastatic renal-cell cancer: a retrospective analysis of phase 2 and phase 3 trials.

Authors: Hai T Tran; Yuan Liu; Amado J Zurita; Ying Lin; Katherine L Baker-Neblett; Anne-Marie Martin; Robert A Figlin; Thomas E Hutson; Cora N Sternberg; Rafael G Amado; Lini N Pandite; John V Heymach
Journal: Lancet Oncol Date: 2012-07-02 Impact factor: 41.316

8. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206.

Authors: Brian I Rini; Susan Halabi; Jonathan E Rosenberg; Walter M Stadler; Daniel A Vaena; San-San Ou; Laura Archer; James N Atkins; Joel Picus; Piotr Czaykowski; Janice Dutcher; Eric J Small
Journal: J Clin Oncol Date: 2008-10-20 Impact factor: 44.544

Adjusting for misclassification in a stratified biomarker clinical trial.

1. Estimation of genotype error rate using samples with pedigree information--an application on the GeneChip Mapping 10K array.

2. The retinoblastoma tumor suppressor controls androgen signaling and human prostate cancer progression.

3. Innovative Clinical Trial Designs: Toward a 21st-Century Health Care System.

4. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma.

5. On the efficiency of targeted clinical trials.

6. Prospective alpha allocation in the Clarification of Optimal Anticoagulation through Genetics (COAG) trial.

7. Prognostic or predictive plasma cytokines and angiogenic factors for patients treated with pazopanib for metastatic renal-cell cancer: a retrospective analysis of phase 2 and phase 3 trials.

8. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206.

9. Retinoblastoma tumor suppressor status is a critical determinant of therapeutic response in prostate cancer cells.

Review 10. Study designs and statistical analyses for biomarker research.

1. Relative efficiency of precision medicine designs for clinical trials with predictive biomarkers.

2. On the design and the analysis of stratified biomarker trials in the presence of measurement error.

3. Biomarkers in early-phase trials: fundamental issues.