2021 Clinical Trials Symposium
October 20, 2021
9:00 AM EST
The OARSI Clinical Trials Symposium is scheduled for Wednesday, October 20th at 9 am EDT. This symposium is envisioned as a debate continuing the discussions held with OARSI, the FDA, and the Arthritis Foundation (AF) in June of 2021. The debate “How can we design clinical trials for regulatory approval in OA” will feature OARSI members and individuals from the FDA. The agenda and registration details are below.
1. Welcome by moderator (Ali Mobasheri, OARSI President)
2. Where do we stand with compounds in clinical trials for OA? (with special remarks on potential DMOADs and how that align with outcome studies) (Marc Hochberg) – 30 minutes
3. Debate: “How can we design clinical trials for regulatory approval in OA?” (Citation: Concept Endpoints Informing Design Considerations for Confirmatory Clinical Trials in Osteoarthritis.) A clinically relevant approach to the development of such drugs is to utilize a long-term clinical endpoint, i.e., a direct measure of how patients function, feel, or survive, as the primary endpoint in clinical trials.
a. Setting the scene –the current regulatory landscape for OA (Nikolay Nikolov; with colleague Dr. Yura Kim – 15 minutes
b. Lessons learned from osteoporosis, NASH, Diabetes and subpart H: how to tackle hard outcomes (Morten Karsdal) – 15 minutes
c. Is there any benefit to distinguishing disease from illness in OA? (Virginia Kraus) – 15 minutes
d. Is pain the disease or the consequence of disease? (Lars Arendt-Nielsen) – 15 minutes
e. Debate (All presenters) – 30 minutes
4. Closing remarks by moderator (Ali Mobasheri)