Clinical Trial Symposium
Date/Time: Wednesday, May 1, 2019 - 10:30 AM to 3:30 PM
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.
Review of the Updated FDA Guidelines and Discussion of their Implications
Jeymi Tambiah, MD
- Review of the actual document and the implications
- OA as a disease of the whole joint - which tissue is on the critical path?
- The role of TKRs and outcomes in the future
- What is clinical benefit to patients?
Discussion – How to Run a Phase III Clinical Study Yesterday and Today in Reflection of the New Guidelines
Clinical trial design in the era subpart H and the FDA-OARSI Initiative
Virginia Byers Kraus, MD, PhD – Duke University
- Accelerated Approval Accepted - Virginia Byers Kraus, MD, PhD – Duke University
- Accelerated Approval Rejected – Jeffrey Kraines, MD, EMD Serono
General discussion 15 minutes on the potential of subpart H for OA
Break for Lunch
Imaging in OA
Felix Eckstein, MD - Paracelsus Medical University Institute of Anatomy
- Can we use imaging to enrich for outcome (TKR)?
- Is imaging a surrogate of how a patient feels, functions, or survives?
- As a surrogate endpoint
- As inclusion criteria
- As a surrogate endpoint
- As inclusion criteria (KL grading, fixed JSW, what views)
Discussion on imaging technologies supporting clinical development in OA
Endotypes in OA that may Help Guide Clinical Trial Design - APPROACH
Chris Ladel, PhD - EMD Serono
Anne-Christine Bay-Jensen, MSc, PhD – Nordic Bioscience
- The inflammatory phenotype – is it a true progression phenotype we may use for specific anti-inflammatory drugs in OA?
- The bone phenotype – can this be targeted in OA?
- Is there a metabolic phenotype? And which potential treatment may be repositioned for this?
- The cartilage phenotype and potential targets and treatments: Can we identify a special phenotype for anabolic treatment versus anti-catabolic treatment?
Discussion – Are Endotypes Needed for OA Clinical Development and are they Feasible?
FNIH stage 2: an initiative to support clinical trial design
David Hunter, MBBS, PhD, MSc, FRACP - Institute of Bone and Joint Research, Royal North Shore Hospital
- Soluble biomarker update
The Aggrecanase OA Research Transitioning into Clinical Data - Where are we and what may we Expect?
Ellen van der Aar, PhD - Galapagos
- Focus on transitioning from a preclinical into a clinical project
- Design of a Phase II study – one drug for all endotypes?
Discussion – is there a special endotype for ADAMTS inhibitors or does one size fit all?
Discussion - What did we learn and how can we do better?
This Clinical Trial Symposium requires an additional ticketed fee and can be purchased online at registration. This symposia has been designated for 4.75 AMA PRA Category 1 CreditsTM.