Clinical Trial Symposium
Date/Time: Wednesday, April 29, 2020 - 10:30 AM to 3:30 PM
Log in to Add to My Schedule
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