Literature DB >> 20199395

A pathway and approach to biomarker validation and qualification for osteoarthritis clinical trials.

David J Hunter1, Elena Losina, Ali Guermazi, Deb Burstein, Marissa N Lassere, Virginia Kraus.   

Abstract

This narrative review outlines the work done in other fields with regards biomarker validation and qualification and the lessons that we may learn from this experience. Defining a universally agreed upon path for biomarker validation and qualification is urgently needed to circumvent many of the hurdles faced in OA therapeutic development irrespective of whether we are discussing biochemical markers, imaging markers or other measures. This review proposes a path that may be suitable for osteoarthritis and poses some logical next steps that will take us in this direction.

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Year:  2010        PMID： 20199395      PMCID： PMC3261486          DOI： 10.2174/138945010791011947

Source DB:  PubMed          Journal:  Curr Drug Targets        ISSN： 1389-4501            Impact factor:   3.465


  47 in total

Review 1.  Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies.

Authors:  L J Lesko; A J Atkinson
Journal:  Annu Rev Pharmacol Toxicol       Date:  2001       Impact factor: 13.820

2.  Analysis of the discordance between radiographic changes and knee pain in osteoarthritis of the knee.

Authors:  M T Hannan; D T Felson; T Pincus
Journal:  J Rheumatol       Date:  2000-06       Impact factor: 4.666

3.  The price of innovation: new estimates of drug development costs.

Authors:  Joseph A DiMasi; Ronald W Hansen; Henry G Grabowski
Journal:  J Health Econ       Date:  2003-03       Impact factor: 3.883

4.  An inauspicious start for the US National Biospecimen Network.

Authors:  Karen Birmingham
Journal:  J Clin Invest       Date:  2004-02       Impact factor: 14.808

5.  Combining several screening tests: optimality of the risk score.

Authors:  Martin W McIntosh; Margaret Sullivan Pepe
Journal:  Biometrics       Date:  2002-09       Impact factor: 2.571

6.  Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop.

Authors:  V G De Gruttola; P Clax; D L DeMets; G J Downing; S S Ellenberg; L Friedman; M H Gail; R Prentice; J Wittes; S L Zeger
Journal:  Control Clin Trials       Date:  2001-10

Review 7.  Imaging in osteoarthritis.

Authors:  Ali Guermazi; Deborah Burstein; Philip Conaghan; Felix Eckstein; Marie-Pierre Hellio Le Graverand-Gastineau; Helen Keen; Frank W Roemer
Journal:  Rheum Dis Clin North Am       Date:  2008-08       Impact factor: 2.670

Review 8.  Is knee radiography useful for studying the efficacy of a disease-modifying osteoarthritis drug in humans?

Authors:  Steven A Mazzuca; Kenneth D Brandt
Journal:  Rheum Dis Clin North Am       Date:  2003-11       Impact factor: 2.670

Review 9.  Principles of use of surrogate markers and endpoints.

Authors:  C Kluft
Journal:  Maturitas       Date:  2004-04-15       Impact factor: 4.342

Review 10.  Overview of biomarkers and surrogate endpoints in drug development.

Authors:  John A Wagner
Journal:  Dis Markers       Date:  2002       Impact factor: 3.434
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  26 in total

Review 1.  Pharmacologic therapy for osteoarthritis--the era of disease modification.

Authors:  David J Hunter
Journal:  Nat Rev Rheumatol       Date:  2010-11-16       Impact factor: 20.543

2.  Clinical relevance of bone marrow lesions in OA.

Authors:  C Kent Kwoh
Journal:  Nat Rev Rheumatol       Date:  2012-12-11       Impact factor: 20.543

Review 3.  Biomarkers for osteoarthritis: current position and steps towards further validation.

Authors:  David J Hunter; Michael Nevitt; Elena Losina; Virginia Kraus
Journal:  Best Pract Res Clin Rheumatol       Date:  2014-02       Impact factor: 4.098

Review 4.  The promise of biomarkers in diagnosing major depression in primary care: the present and future.

Authors:  Eva E Redei; Neha S Mehta
Journal:  Curr Psychiatry Rep       Date:  2015-08       Impact factor: 5.285

Review 5.  OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.

Authors:  V B Kraus; F J Blanco; M Englund; Y Henrotin; L S Lohmander; E Losina; P Önnerfjord; S Persiani
Journal:  Osteoarthritis Cartilage       Date:  2015-05       Impact factor: 6.576

Review 6.  Systematic review of the concurrent and predictive validity of MRI biomarkers in OA.

Authors:  D J Hunter; W Zhang; Philip G Conaghan; K Hirko; L Menashe; L Li; W M Reichmann; E Losina
Journal:  Osteoarthritis Cartilage       Date:  2011-03-23       Impact factor: 6.576

Review 7.  Post-traumatic osteoarthritis: from mouse models to clinical trials.

Authors:  Christopher B Little; David J Hunter
Journal:  Nat Rev Rheumatol       Date:  2013-05-21       Impact factor: 20.543

8.  Dendritic spine remodeling following early and late Rac1 inhibition after spinal cord injury: evidence for a pain biomarker.

Authors:  Peng Zhao; Myriam Hill; Shujun Liu; Lubin Chen; Lakshmi Bangalore; Stephen G Waxman; Andrew M Tan
Journal:  J Neurophysiol       Date:  2016-03-02       Impact factor: 2.714

9.  Magnetic resonance biomarkers in radiation oncology: The report of AAPM Task Group 294.

Authors:  Kiaran P McGee; Ken-Pin Hwang; Daniel C Sullivan; John Kurhanewicz; Yanle Hu; Jihong Wang; Wen Li; Josef Debbins; Eric Paulson; Jeffrey R Olsen; Chia-Ho Hua; Lizette Warner; Daniel Ma; Eduardo Moros; Neelam Tyagi; Caroline Chung
Journal:  Med Phys       Date:  2021-05-20       Impact factor: 4.071

10.  Applications of proteomics to osteoarthritis, a musculoskeletal disease characterized by aging.

Authors:  Ali Mobasheri
Journal:  Front Physiol       Date:  2011-12-23       Impact factor: 4.566
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