Clinical Trial Symposium
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
- 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
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
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
- 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