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Osteoarthritis Initiative
Updated June 24,1999
OA Biochemical Biomarkers Subcommittee Discussions Summary
Attendees:
Thasia Woodworth, chair (Pfizer)
Bernadette Tyree (National Institute of Arthritis and Musculoskeletal and Skin Diseases)
David Eyre (University of Washington)
Kenneth Gruber (National Institute of Dental and Craniofacial Research)
Zeb Horowitz (Novartis)
Michael Lark (SmithKline Beecham)
Ruth Raiss (Hoechst AG (Germany))
Stephen Myers (Eli Lilly)
Yetunde Taiwo (Proctor & Gamble)
Robin Poole (McGill University)
Linda Sandell (Washington University)1
Jean-Claude Becker (Bristol-Myers Squibb)
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1representing the Orthopaedic Research Society
Goals:
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Long Term: To enhance the "clinical do-ability" of OA clinical trials, enabling expeditious identification of novel, disability-preventing treatments
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Medium Term: To gain acceptance of identified markers as surrogate for OA status and improvement, or slowing of progression
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Short Term: Establish a comprehensive understanding of available and candidate biochemical markers
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Characterization of patients with measurably progressing OA, able to detect change < 1 year
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Assays: validated methodology, reference standards
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Facilitate recognition of validated clinical use (specimen archives with clinical data, comparisons among markers)
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Actions for committee:
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Submit* description of marker(s) which you believe may qualify to become surrogate"
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Assay method, availability of reference standard, publications, list of needs for clinical validation
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Suggest speakers for "Winter Meeting" - see list below *Submission: email: thasia_g_woodworth@groton.pfizer.com
Biochemical marker opportunities:
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Characterize Patient Populations - "diagnostic" (med./Long term), monitoring need for therapy, effect of therapy, safety
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Correlate with clinically relevant outcomes:
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Pain
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Disability - Health Economics
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Function
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Joint replacement
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Maintenance of Structure (surrogate for function - how much better on treatment???)
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Mechanisms for marker assessment:
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Study design - specific patient subsets with CLINICAL DATABASE
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Sample achives: Biofluids = serum/plasma
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Urine
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WBC/DNA
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Synovial fluid
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Associate with clinical data /outcomes, safety
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Synchronize (collect archive samples anonymously) in clinical trials?
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Relate to short, intermediate, and long-term outcomes, especially disability
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Issues of concern:
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Conditions of access
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Confidentiality / Informed consent "Anonymous" databases
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Proprietary concerns
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Patents
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Cost
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Diagnosis, assessing progression
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Which markers to assay?
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Biochemical, genetic
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Distinguish mechanism of agent from (measuring cartilage status)
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Safety markers?
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Patterns - bone, cartilage (degradation/synthesis)
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Disease status
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Pt. Management
Process:
Establish baseline: "OA Clinical Paradigms" - post-injury, genetic, degenerative, combinations
Define disease - where can we intervene with therapy?
Clinical end points to be measured
Critically evaluate current info.
Candidate markers - current available
Patient Populations
Current longitudinal studies
Guidance for future studies
Cross-sectional and longitudinal studies
Education - including the public
Hypotheses generated - priorities for current archives
Standards for collection, storage
Clinical data
Database acquisition
Structure for prospective
Methodology for samples - storage/cataloguing
Assay standards
Control population?
Recognize comorbidities