Dr Roemer and Colleagues Outline the Role of Imaging in Disease-Modifying OA Clinical Trials
In this recent paper BICL‘s Dr. Roemer and Colleagues describe in detail the current role of imaging in clinical trials of disease modifying osteoarthritis drugs to help trialists setting up trials and running them in the most efficient and successful way possible. The focus is on radiography and MRI and their role as both inclusion criteria and structural outcome measures. Today, radiography is primarily used to define the severity of structural disease and to measure joint space width as an inclusionary criterion. Limitations include a lack of reproducibility, a lack of sensitivity, specificity, and responsiveness regarding structural progression, and an insufficient ability to depict diagnoses of exclusion. MRI is more sensitive and specific in assessing tissue damage and its progression. Using abbreviated imaging protocols and rapid image assessment, MRI may be applied at screening. Quantitative and semiquantitative approaches have been commonly used as outcome measures, and both have advantages and disadvantages that are being discussed. Further a suggestion and flow chart is presented how to chronologically apply the different imaging methods in the context of screening and on-study evaluation.