Osteomyelitis lacks a universally accepted definition of "cure," which makes clinical trial endpoints hard to design and compare. The article argues that trials must move beyond end-of-therapy snapshots toward long-term (6–12 month), adjudicated endpoints that account for late relapses, surgical confounding, and inconsistent site practices. Citing recent trials OVIVA and SALATIO as models, it recommends a precise, composite cure definition; blinded endpoint adjudication; standardized surgical and oral-switch criteria; and imaging core labs. Sponsors who solve this "endpoint problem" early are best positioned to bring the first approved osteomyelitis therapy to market. The post Defining Cure in Osteomyelitis Clinical Trials: The Endpoint Problem That Keeps Derailing Trials appeared first on Allucent .

Defining Cure in Osteomyelitis Clinical Trials: The Endpoint Problem That Keeps Derailing Trials
Shreya Yeramilli

