Integrating biomarkers in clinical trials (Q37853183)

24 August 2017

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title

Integrating biomarkers in clinical trials (English)

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24 August 2017

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1

Marc Buyse

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Aimery de Gramont

6

object named as

Aimery de Gramont

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Stefan Michiels

2

object named as

Stefan Michiels

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24 August 2017

Daniel J Sargent

3

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PubMed ID

21405968

24 August 2017

Axel Grothey

4

1 reference

PubMed ID

21405968

24 August 2017

Alastair Matheson

5

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24 August 2017

1 March 2011

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Expert Review of Molecular Diagnostics: new diagnostic technologies are set to revolutionise healthcare

24 August 2017

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24 August 2017

11

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24 August 2017

2

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24 August 2017

171-182

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Clinical trials for predictive medicine: new challenges and paradigms

24 August 2017

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https://api.crossref.org/works/10.1586%2FERM.10.120

Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology

21 January 2018

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https://api.crossref.org/works/10.1586%2FERM.10.120

Biomarkers and surrogate endpoints: preferred definitions and conceptual framework

21 January 2018

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https://api.crossref.org/works/10.1586%2FERM.10.120

Statistical evaluation of biomarkers as surrogate endpoints: a literature review

21 January 2018

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https://api.crossref.org/works/10.1586%2FERM.10.120

The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogat

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Biomarkers and surrogate end points--the challenge of statistical validation

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Gene expression profiling predicts clinical outcome of breast cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

A gene-expression signature as a predictor of survival in breast cancer

21 January 2018

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https://api.crossref.org/works/10.1586%2FERM.10.120

Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer

21 January 2018

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https://api.crossref.org/works/10.1586%2FERM.10.120

Strong time dependence of the 76-gene prognostic signature for node-negative breast cancer patients in the TRANSBIG multicenter independent validation series

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Gene-expression signatures in breast cancer

21 January 2018

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https://api.crossref.org/works/10.1586%2FERM.10.120

What should physicians look for in evaluating prognostic gene-expression signatures?

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by Cetuximab plus chemotherapy

21 January 2018

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https://api.crossref.org/works/10.1586%2FERM.10.120

Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

K-ras mutations and benefit from cetuximab in advanced colorectal cancer.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Molecular markers and biological targeted therapies in metastatic colorectal cancer: expert opinion and recommendations derived from the 11th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2009.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Somatic mutations in BRCA1 and BRCA2 could expand the number of patients that benefit from poly (ADP ribose) polymerase inhibitors in ovarian cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Statistical considerations in evaluating pharmacogenomics-based clinical effect for confirmatory trials.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Use of archived specimens in evaluation of prognostic and predictive biomarkers

21 January 2018

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https://api.crossref.org/works/10.1586%2FERM.10.120

Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial

21 January 2018

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https://api.crossref.org/works/10.1586%2FERM.10.120

Gene-expression-based prognostic assays for breast cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Clinical trials design and treatment tailoring: general principles applied to breast cancer research

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Sample size requirements and length of study for testing interaction in a 2 x k factorial design when time-to-failure is the outcome [corrected]

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Clinical trial designs for predictive marker validation in cancer treatment trials

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Clinical trial designs for predictive biomarker validation: one size does not fit all.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Genomic advances and their impact on clinical trial design

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Randomized clinical trials with biomarkers: design issues

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Bayesian adaptive randomization designs for targeted agent development

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Randomized phase III clinical trial designs for targeted agents

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

A predictive probability design for phase II cancer clinical trials

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Bayesian adaptive design for targeted therapy development in lung cancer--a step toward personalized medicine

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Molecular markers to individualize adjuvant therapy for colon cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

The use of genomics in clinical trial design

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Statistical issues in translational cancer research

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

INTERESTing biomarker to select IDEAL patients for epidermal growth factor receptor tyrosine kinase inhibitors: yes, for EGFR mutation analysis, others, I PASS.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Effective incorporation of biomarkers into phase II trials

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Phase I study of everolimus plus weekly paclitaxel and trastuzumab in patients with metastatic breast cancer pretreated with trastuzumab

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Pharmacogenomic predictor discovery in phase II clinical trials for breast cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

A Bayesian adaptive design with biomarkers for targeted therapies

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Pilot study using molecular profiling of patients' tumors to find potential targets and select treatments for their refractory cancers.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

KIT mutations and dose selection for imatinib in patients with advanced gastrointestinal stromal tumours

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Outcome of patients with advanced gastro-intestinal stromal tumours crossing over to a daily imatinib dose of 800 mg after progression on 400 mg.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Phase II clinical trial design for noncytotoxic anticancer agents for which time to disease progression is the primary endpoint.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer)

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

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

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect.

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Adjusted significance levels for subgroup analyses in clinical trials

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Optimizing trial design: sequential, adaptive, and enrichment strategies

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

A threshold sample-enrichment approach in a clinical trial with heterogeneous subpopulations

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

Customizing Cisplatin Based on Quantitative Excision Repair Cross-Complementing 1 mRNA Expression: A Phase III Trial in Non–Small-Cell Lung Cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1586%2FERM.10.120

21 January 2018

Identifiers

DOI

10.1586/ERM.10.120

1 reference

24 August 2017

1 reference

PubMed ID

21405968