(Q38418590)

2 September 2017

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title

Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization (English)

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2 September 2017

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S Amur

1

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2 September 2017

L LaVange

2

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2 September 2017

I Zineh

3

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2 September 2017

S Buckman-Garner

4

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2 September 2017

J Woodcock

5

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2 September 2017

language of work or name

English

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publication date

6 June 2015

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Clinical Pharmacology & Therapeutics

2 September 2017

published in

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2 September 2017

volume

98

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2 September 2017

issue

1

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2 September 2017

page(s)

34-46

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Acceptance of biomarker-based tests for application in clinical practice: criteria and obstacles

2 September 2017

cites work

1 reference

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21 January 2018

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21 January 2018

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Biomarkers: refining diagnosis and expediting drug development - reality, aspiration and the role of open innovation

21 January 2018

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Why most published research findings are false

21 January 2018

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Reproducibility in science: improving the standard for basic and preclinical research

21 January 2018

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Catalyzing the Critical Path Initiative: FDA's progress in drug development activities

21 January 2018

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The predictive safety testing consortium and the coalition against major diseases.

21 January 2018

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Biomarkers and surrogate endpoints: preferred definitions and conceptual framework

21 January 2018

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Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.

21 January 2018

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Believe it or not: how much can we rely on published data on potential drug targets?

21 January 2018

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Policy: NIH plans to enhance reproducibility

21 January 2018

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Power failure: why small sample size undermines the reliability of neuroscience

21 January 2018

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The value, qualification, and regulatory use of surrogate end points in drug development

21 January 2018

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Validation of surrogate endpoints in advanced solid tumors: systematic review of statistical methods, results, and implications for policy makers.

21 January 2018

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Surrogate end points in clinical trials: are we being misled?

21 January 2018

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Correlation of glucose regulation and hemoglobin AIc in diabetes mellitus

21 January 2018

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Relationship between blood glucose level and mortality in type 2 diabetes mellitus: a systematic review

21 January 2018

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Direct measurement of viraemia in patients infected with HIV-1 and its relationship to disease progression and zidovudine therapy

21 January 2018

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Association of plasma human immunodeficiency virus type 1 RNA level with risk of clinical progression in patients with advanced infection. AIDS Clinical Trials Group (ACTG) 116B/117 Study Team. ACTG Virology Committee Resistance and HIV-1 RNA Workin

21 January 2018

1 reference

The use of plasma HIV RNA as a study endpoint in efficacy trials of antiretroviral drugs

21 January 2018

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Surrogate endpoints in clinical trials: definition and operational criteria

21 January 2018

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Principal stratification in causal inference

21 January 2018

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A bayesian approach to surrogacy assessment using principal stratification in clinical trials

21 January 2018

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On meta-analytic assessment of surrogate outcomes.

21 January 2018

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The biomarkers consortium

21 January 2018

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7 January 2021

A prototypical process for creating evidentiary standards for biomarkers and diagnostics

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7 January 2021

Prediction of progression to AIDS with serum HIV-1 RNA and CD4 count

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7 January 2021

Prentice's Approach and the Meta-Analytic Paradigm: A Reflection on the Role of Statistics in the Evaluation of Surrogate Endpoints

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7 January 2021

Surrogate marker evaluation from an information theory perspective

1 reference

7 January 2021

Statistical Validation of Surrogate Endpoints: Problems and Proposals

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7 January 2021

Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation

1 reference

7 January 2021

Identifiers

DOI

10.1002/CPT.136

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2 September 2017

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