The combination of an aging population and gains in longevity increases the significance and societal burden of osteoarthritis (OA). Bioclinica has worked actively in the application of imaging for OA clinical trials for more than 20 years, but a safe and effective disease-modifying therapy remains elusive. Nevertheless, interest in this disease remains high and pharmaceutical and biotech companies continue to discover and test new candidate therapies in hopes of solving this unmet medical need.
While a regulatory approval has not been achieved, advances in trial design and methods of evaluating biomarkers of interest have occurred, providing new confidence in running effective and efficient trials. One of the first challenges in designing an OA trial is selecting the right patient population to study. Clear clinical and imaging criteria have been established to diagnose the patient suffering from osteoarthritis. However, a successful trial will depend on more than that. Based on the candidate drug’s therapeutic target and method of action, the study population must also meet the endotype/phenotype requirements to maximize the chance to see a therapeutic effect. In addition, given the slowly evolving nature of this disease, careful subject selection can help shorten trial duration facilitating go/no-go and dose selection decisions.
It is now standard to use both radiography and MRI to select study participants who meet the baseline characteristics required by the trial design while excluding subjects with confounding conditions and other pathology. Moreover, imaging is shown to be useful for identifying an enriched cohort with increased risk of progression (e.g. radiographic joint space narrowing or cartilage loss).
Register for this webinar to explore the role of imaging in determining subject eligibility in OA trials. Topics to be covered will include:
- The complementary roles of radiography and MRI for subject selection and when to use each
- Specific selection criteria to target the right OA patients
- Workflow strategies for efficient screening
- The current status of prognostic imaging biomarkers for disease progression