The use of genomics in clinical trial design.

PubWeight™: 2.61‹?› | Rank: Top 1%

🔗 View Article (PMID 18829477)

Published in Clin Cancer Res on October 01, 2008

Authors

Richard Simon1

Author Affiliations

1: Biometric Research Branch, National Cancer Institute, 9000 Rockville Pike, Bethesda, MD 20892, USA. rsimon@nih.gov

Articles citing this

Charting a course for genomic medicine from base pairs to bedside. Nature (2011) 9.39

Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst (2009) 7.95

Randomized clinical trials with biomarkers: design issues. J Natl Cancer Inst (2010) 3.30

Molecular classification and novel targets in hepatocellular carcinoma: recent advancements. Semin Liver Dis (2010) 2.46

Gene-expression signature of vascular invasion in hepatocellular carcinoma. J Hepatol (2011) 2.39

Prognostic gene expression signature for patients with hepatitis C-related early-stage cirrhosis. Gastroenterology (2013) 2.13

A genomic and clinical prognostic index for hepatitis C-related early-stage cirrhosis that predicts clinical deterioration. Gut (2014) 1.84

Assessing the role of circulating, genetic, and imaging biomarkers in cardiovascular risk prediction. Circulation (2011) 1.77

Validation of analytic methods for biomarkers used in drug development. Clin Cancer Res (2008) 1.73

Statistical design of personalized medicine interventions: the Clarification of Optimal Anticoagulation through Genetics (COAG) trial. Trials (2010) 1.72

Envisioning the future of early anticancer drug development. Nat Rev Cancer (2010) 1.67

Validation of biomarker-based risk prediction models. Clin Cancer Res (2008) 1.57

The COXEN principle: translating signatures of in vitro chemosensitivity into tools for clinical outcome prediction and drug discovery in cancer. Cancer Res (2010) 1.54

Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology. Per Med (2010) 1.47

Institutional shared resources and translational cancer research. J Transl Med (2009) 1.41

Fool's gold, lost treasures, and the randomized clinical trial. BMC Cancer (2013) 1.39

Are randomized trials obsolete or more important than ever in the genomic era? Genome Med (2013) 1.33

Adaptive clinical trial designs for simultaneous testing of matched diagnostics and therapeutics. Clin Cancer Res (2011) 1.32

Emerging concepts in biomarker discovery; the US-Japan Workshop on Immunological Molecular Markers in Oncology. J Transl Med (2009) 1.31

Implementing prognostic and predictive biomarkers in CRC clinical trials. Nat Rev Clin Oncol (2011) 1.31

What should physicians look for in evaluating prognostic gene-expression signatures? Nat Rev Clin Oncol (2010) 1.29

Statistical challenges in preprocessing in microarray experiments in cancer. Clin Cancer Res (2008) 1.19

Advancing precision medicine for prostate cancer through genomics. J Clin Oncol (2013) 1.16

Integrating predictive biomarkers and classifiers into oncology clinical development programmes. Nat Rev Drug Discov (2011) 1.14

Translating biomarkers to clinical practice. Mol Psychiatry (2011) 1.09

Clinical trials for predictive medicine: new challenges and paradigms. Clin Trials (2010) 1.08

Potential responders to FOLFOX therapy for colorectal cancer by Random Forests analysis. Br J Cancer (2011) 1.06

Analysis of DNA microarray expression data. Best Pract Res Clin Haematol (2009) 1.03

Quantifying factors for the success of stratified medicine. Nat Rev Drug Discov (2011) 1.00

Genetic architecture of colorectal cancer. Gut (2015) 0.97

Pathogenesis and prevention of hepatitis C virus-induced hepatocellular carcinoma. J Hepatol (2014) 0.96

Comparison of global versus epidermal growth factor receptor pathway profiling for prediction of lapatinib sensitivity in bladder cancer. Neoplasia (2009) 0.92

The benefits of using genetic information to design prevention trials. Am J Hum Genet (2013) 0.91

Use of yeast chemigenomics and COXEN informatics in preclinical evaluation of anticancer agents. Neoplasia (2011) 0.89

DNA repair and personalized breast cancer therapy. Environ Mol Mutagen (2010) 0.88

Drug-diagnostics co-development in oncology. Front Oncol (2013) 0.88

Unblocking blockbusters: using boolean text-mining to optimise clinical trial design and timeline for novel anticancer drugs. Cancer Inform (2009) 0.87

Study designs and statistical analyses for biomarker research. Sensors (Basel) (2012) 0.86

Systems biology and cancer: promises and perils. Prog Biophys Mol Biol (2011) 0.85

Impact of bioinformatic procedures in the development and translation of high-throughput molecular classifiers in oncology. Clin Cancer Res (2013) 0.84

Genomic biomarkers for personalized medicine: development and validation in clinical studies. Comput Math Methods Med (2013) 0.84

Genomic markers for decision making: what is preventing us from using markers? Nat Rev Clin Oncol (2009) 0.82

Current targeted therapies in the treatment of advanced colorectal cancer: a review. Ther Adv Med Oncol (2016) 0.81

Biomarker-based targeting of the androgen-androgen receptor axis in advanced prostate cancer. Adv Urol (2012) 0.81

Moving from correlative science to predictive oncology. EPMA J (2010) 0.81

New evidence-based adaptive clinical trial methods for optimally integrating predictive biomarkers into oncology clinical development programs. Chin J Cancer (2013) 0.81

Evaluating surrogate endpoints, prognostic markers, and predictive markers: Some simple themes. Clin Trials (2014) 0.80

Integrating complex genomic datasets and tumour cell sensitivity profiles to address a 'simple' question: which patients should get this drug? BMC Med (2009) 0.79

Adaptive clinical trial designs in oncology. Chin Clin Oncol (2014) 0.79

Creative trial design in RA: optimizing patient outcomes. Nat Rev Rheumatol (2013) 0.78

Improving clinical trial efficiency by biomarker-guided patient selection. Trials (2014) 0.78

Why the Shift? Taking a Closer Look at the Growing Interest in Niche Markets and Personalized Medicine. World Med Health Policy (2015) 0.77

Multiple testing of treatment-effect-modifying biomarkers in a randomized clinical trial with a survival endpoint. Stat Med (2011) 0.77

Prognostic and predictive value of immunological parameters for chemoradioimmunotherapy in patients with pancreatic adenocarcinoma. Br J Cancer (2015) 0.76

Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review. PLoS One (2016) 0.76

Strategies for power calculations in predictive biomarker studies in survival data. Oncotarget (2016) 0.76

Data integration to prioritize drugs using genomics and curated data. BioData Min (2016) 0.75

Optimal marker-strategy clinical trial design to detect predictive markers for targeted therapy. Biostatistics (2016) 0.75

Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review. J Pers Med (2017) 0.75

How to develop treatments for biologically heterogeneous "diseases". Clin Cancer Res (2012) 0.75