2022 Clinical Trials Symposium
The pain of OA - deconstruction of pain and PROs for the benefit of patients and clinical trial design
Welcome by Moderator
Session 1: The pains of OA - local versus central pain signals
Are OA symptoms (illness) modifiable?
Can we differentiate pain with and without central sensitization? (2)
For purposes of OA clinical trials, what pain features are most directly related to the local joint pathology? (1)
Session Chairs: Ali Mobasheri & Tuhina Neogi
Session 2: Quantification of pain and function in an objective way
Which biomarkers relate to PROs and predict PROs?
How to predict outcome and enrich for outcome in OA clinical studies?
Can biomarkers (soluble and imaging) help to differentiate symptoms from local joint pathology from symptoms that are secondary?
When is pain related to outcome and not?
How to more objectively include function as PROs
Objectively measured function
Session Chairs: Morten Karsdal & Virginia Kraus
Lunch and Networking Break
Session 3: Clinical Trial Design and reflection by FDA/EMA
Review of trials and their outcomes using these two novel study designs (non-OA)
How to implement these designs in OA trials
Are there any OA trials that could be interrogated retrospectively with these designs in mind
FDA/EMA regulatory perspective on these trial designs
Panel discussion with EMA and FDA
Session Chairs: Jeff Katz and Jamie Tambiah
Closing Remarks