Preventative and Disease-Modifying Investigations for Osteoarthritis Management Are Significantly Underrepresented in the Clinical Trial Pipeline: A 2020 Review.

Abstract

PURPOSE\nto conduct a review of active U.S. based clinical trials investigating prevention, symptom resolution, and disease-modifying therapies for osteoarthritis.\n\n\nMETHODS\nA review of currently active clinical trials for OA using data obtained from ClinicalTrials.gov database as of August 2020 was conducted. Inclusion criteria were active studies registered in the U.S. that involved the prevention, symptom resolution, or disease-modification of OA. Descriptive statistics were recorded and summarized.\n\n\nRESULTS\n3859 clinical trials were identified and 311 were included in final analysis. Of the currently active trials, 89% (n=275) targeted symptom resolution in patients with existing OA, 6% (n=19) targeted OA disease-modifying therapeutics, and 5% (n=16) targeted the prevention of OA in high-risk patients (P < .001). Primary interventions included medical devices (44%, n=137), pharmaceutical drugs (14%, n=42), surgical procedures (14%, n=42), cellular biologics (13%, n=41), and behavioral therapies (13%, n=41). There was a significantly higher number of disease-modifying therapeutics for cellular biologics than pharmaceutical trials (30% vs.14%, respectively) (P = .015). The majority of trials targeted the knee joint (63%, P = .042) with 38% of all trials evaluating joint arthroplasty. There were no significant differences between private sector and government funding sources (43% and 49%, respectively) (P = .288), yet there was a significantly lower rate of funding from industry (8%) (P = .026).\n\n\nCONCLUSION\nThere was a significantly higher number of clinical trials investigating symptomatic resolution therapy (89%) for existing OA in comparison to prevention (5%) and disease-modifying (6%) therapies. The most common interventions involved medical devices and joint replacement surgery with the knee joint accounting for > 60% of the current clinical trials for OA. There was a significantly higher number of disease-modifying therapeutics for cellular biologics than pharmaceutical drugs. Funding of clinical trials was split between private sector and government, with a low rate of reported funding from industry partners.