BioClinica has expanded its range of imaging services for clinical trials in the area of osteoarthritis (OA). The new positioning device is capable of yielding highly reproducible plain film radiographs capable of showing joint space narrowing changes of less than 0.2 mm per year, according to the company.
Colin G. Miller Ph.D., BioClinica's senior vice president of Medical Affairs, said, “BioClinica has been actively involved in the OA Imaging field for both Disease Modifying Osteoarthritis Drugs (DMOADs) and cartilage repair for years. We have amassed a thorough understanding of the FDA requirements and the challenges for these clinical trials. A new proprietary BioClinica positioning device was specifically developed to provide highly reproducible radiographs of subjects’ knees and address the requirements of demanding DMOAD imaging endpoints.”
Use of the positioning device ensures that patients are positioned correctly and consistently at each visit so that even minimal changes will be accurately measured. The proprietary BioClinica positioner supersedes other positioning devices which have shown significant manufacturing variances and hence positioning variability, according to the company. Both the quality of the positioner results and BioClinica’s methodology in support of one of the largest Phase II studies in this area were recently presented at an OA imaging workshop.