What is the use of having recommendations if no one follows them? A team led by researchers from the Perelman School of Medicine at the University of Pennsylvania, has plunged into the issue of regulatory guidance documents and cartilage repair. Indicating in the October 21, 2015 news release that there is “little to no” adherence to the recommendations published by U.S. and European regulatory agencies on how translational research is conducted and reported in large animal models used to study cartilage repair, the researchers undertook an evaluation of 114 large animal studies.
The team analyzed three sets of regulatory guidance documents published by the U.S. Food and Drug Administration, the European Medicines Agency, and the American Society for Testing and Materials. The team looked at cartilage repair studies published over the past two decades and scored the studies based on adherence to 24 categories appearing in the guidance documents (such as animal age and gender, study duration) and to the methods used for determining successful outcomes, and whether a follow-up MRI or clinical evaluation were performed.
“When we started this project, we assumed that there would be strong positive correlation between the publication of the guidance documents and the level of adherence to these guidelines following publication, ” said Robert Mauck, Ph.D., an associate professor of Orthopedic Surgery and Bioengineering and director of Penn’s McKay Orthopaedic Research Laboratory. “However, when we completed our analysis, we were surprised to find that for the large animal studies we examined, most did not follow the guidelines to any great extent. This got us thinking about the reasons behind the lack of adherence, and the steps that could be taken to help the field more closely align with these recommendations.”
The research team also included Christian Pfeifer, M.D., of the Regensburg University Medical Center and Matthew Fisher, Ph.D., of North Carolina State University and the University of North Carolina at Chapel Hill, former postdoctoral fellows in the McKay Orthopaedic Research Laboratory.
Dr. Mauck told OTW, “We were quite surprised to discover that the publication of the guidance documents from regulatory and standards organization had little impact on the field of preclinical large animal models of cartilage repair, and how poor overall the adherence to these guidelines was. This made us consider the reasons for this low adherence to and lead to a broader discussion on the ways in which these guidelines could be more widely implemented and adopted by the field.”
“Orthopaedic surgeons should consider these guidance documents as they develop and participate in translational studies that involve pre-clinical testing in large animal models. They should also participate in the formulation of these documents, so that those assays and outcomes most relevant to clinical translation are represented in these documents. Ultimately, the goal is to improve the rate at which ideas transition to products, with the potential to transform musculoskeletal regenerative medicine.”
