Clinical Trial Symposium

Date/Time: Wednesday, April 29, 2020 - 10:30 AM to 3:30 PM
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Description:

Optimal clinical trials design is needed to bring new treatments to patients. OARSI aims to be the place to go for clinical research and pharma-academia interactions for shaping the future of OA research, and advancing clinical trials design. To facilitate these discussions, and information sharing, OARSI will host a clinical trial symposium, consisting of 6-8 to the point lectures followed by in depth discussions.   

Clinical Science in OA - Status and Perspectives
Jeymi Tambiah

  • How does clinical study design look today and tomorrow in OA? How did we change?
  • Do we need TKR? & how does PROs fit into modern clinical development
  • How can we enrich and standardize for TKR?
  • The relationship between structure and symptoms: Accordance or discordance?
  • Implication for approvals of novel treatment for OA – Symptoms or structure or both?

How to Reduce the Placebo Effect in Clinical Studies
Nathaniel Katz

Methodologies to be applied to establish a differentiation between active treatment and placebo: Medication, screening, blinding, Questionnaires, co-morbidities associated with poor pain reporting

Biomarkers from A Regulatory Perspective: A Case Study from Idea to Approval
Virginia Byers-Kraus
Morten Karsdal

CASE STUDY: The low cartilage repair endotype - are we beginning to understand endotypes? data from the UK biobank study – and how to develop this into a tool that can be us for clinical research as well as in the real world.

The regulatory side of biomarkers – implementation in clinical studies, trial enrichment and in the real world?

  • ​Research use only
  • Qualification of a biomarkers for clinical studies – the drug development tool
  • Standard approval pathways
  • A clinical trial assay (CTA) under CLSI guidelines
  • CDx or complementary diagnostics?
  • Limitations and possibilities – smaller patient population or higher response rates?

Regulatory Considerations for Knee OA Trials
Asger Bihlet & Merck Serono

  • Lessons learned from clinical development in NASH/OP & Cancer with accelerated approval?
  • Why is accelerated approval of the table for OA as the first drug to be approved, and can that be changed?
  • How the regulatory agencies view MRI, X-RAY as compared to soluble biomarkers?
  • What is a PRO, and how is a PRO developed and qualified?
  • Importance of patient reported Pain and importance of patient reported Function in relation to approval/ labeling of knee OA drugs
  • Implication for approvals of novel treatments for OA

The Patient Perspective in OA

Update on the Status, Progress and Future Data of Clinical Trials in the OA Field
Timothy McAlindon

  • ADAMTS-5 – where are we today?
  • FGF-18 – does more cartilage translate into clinical efficacy?
  • Wnt signaling in OA – today and tomorrow
  • Anti-NGF – Who is the optimal patient population?
  • Invossa – stem cell therapy in OA

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