Transformative approaches for effective clinical trials to reduce the disease burden of osteoarthritis

Clinical trial design and endpoints should evolve to evaluate new treatments for pre-osteoarthritis (pre-OA) and early osteoarthritis (OA) by different criteria than those set for symptomatic radiographic OA.

Goals for treating earlier disease states include disease modification and prevention; symptomatic improvement is the primary goal for palliation of irreversible established OA.

Because symptoms may not correlate with structural changes in pre-OA and early OA, primary outcomes should match the intended mechanistic target and the therapeutic goal for the disease state treated.

Critical outcomes should be appropriate for the joint disease states and subtypes of the target population and the therapeutic or mechanistic target of the intervention.