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Knee Osteoarthritis Clinical Trial Design: An Imaging-Based Approach

November 05, 2021
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MMI’s orthopedics expert discusses the imaging modalities and endpoints relevant for the design of knee OA clinical trials.

Key Highlights

  • Practicality and implementation of common X-ray vs. MRI assessments in knee osteoarthritis clinical trials
  • How imaging can be leveraged for trials focused on symptom vs. structural modification
  • Regulatory considerations when designing imaging endpoints
  • Tips for monitoring site compliance and image quality

Osteoarthritis of the knee is a leading cause of disability in the world, especially among the elderly population. In the United States, multiple common risk factors, such as increasing average age and obesity, have led to a rise in knee osteoarthritis incidence. As such, novel therapies and treatments that can slow down, halt, or even reverse the progression of disease are in high demand, and biotech and pharmaceutical companies are continuing to design clinical trials that test the safety and efficacy of new products.

Imaging plays an important role in the design of such clinical trials, as selecting the appropriate imaging modalities, assessments, and endpoints are critical to conducting a successful study. Imaging can be leveraged as part of the subject selection process to identify osteoarthritis phenotypes and to stratify patient populations that are appropriate for a trial. Depending on the type of treatment, imaging assessments can also be designed to focus on the structural correlates of pain, or to evaluate structural changes in cartilage and bone for disease modification claims.

During this presentation, originally hosted as a virtual Xtalks webinar with our friends at MCRA CRO, MMI key opinion leader Dr. Timothy Mosher provides an overview of the imaging modalities for the evaluation of knee osteoarthritis as well as the importance of imaging for trials focuses on symptom modification vs. cartilage repair. Then, Dave McGurl and Iman Ahmad from MCRA consider endpoint design and other regulatory considerations for the above scenarios.

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