title: Measuring and realizing the translational significance of preclinical in vivo studies of painful osteoarthritis.
abstract: In this communication, we discuss some key issues surrounding the translation of preclinical efficacy studies in models of painful osteoarthritis (OA) to the clinical arena. We highlight potential pitfalls which could negatively impact successful translation. These include lack of alignment between a model + endpoint and the intended clinical population, employing testing strategies in animals that are not appropriate for the targeted human population such as pre-emptive treatment and lastly, underestimating the magnitude of the efficacy signal in animals that may be needed to see an effect in the clinical population. Through careful analysis, we highlight the importance of each pitfall by providing relevant examples that will hopefully improve future chances of optimizing translation in the area of OA pain research. We advocate advancing publications directed at comparing methods, outcomes and conclusions between preclinical and clinical studies, regardless of whether the findings are positive or negative, are important for improving the potential for a desired successful translation from the bench to bedside.
authors: Discovery Research, Purdue Pharma L.P., 6 Cedar Brook Drive, Cranbury, NJ 08512, USA.
authors: M
authors: M
authors: Hummel
authors: Discovery Research, Purdue Pharma L.P., 6 Cedar Brook Drive, Cranbury, NJ 08512, USA. Electronic address: garth.whiteside@pharma.com.
authors: G T
authors: GT
authors: Whiteside
mesh_terms: D000818:Animals; D003627:Data Interpretation, Statistical; D004195:Disease Models, Animal; D023381:Endpoint Determination; D006801:Humans; D010003:Osteoarthritis / Q000473:pathology / Q000628:therapy*; D057170:Translational Research, Biomedical; D016896:Treatment Outcome
keywords: Animal model; Clinical; Osteoarthritis; Pain; Preclinical; Translation