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

Abstract

Purpose: To conduct a review of active United States-based clinical trials investigating preventative, symptom resolution, and disease-modifying therapies for osteoarthritis (OA).

Methods: We conducted a review of currently active clinical trials for OA using data obtained from the ClinicalTrials.gov database as of August 2020. The inclusion criteria were active studies registered in the United States that involved the prevention, symptom resolution, or disease modification of OA. Descriptive statistics were recorded and summarized.

Results: A total of 3,859 clinical trials were identified, and 310 were included in the 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 drugs (30% vs 14%) (P = .015). Most 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).

Conclusions: There was a significantly higher number of clinical trials investigating symptomatic resolution therapy (89%) for existing OA in comparison to preventative (5%) and disease-modifying (6%) therapies. The most common interventions involved medical devices and joint replacement surgery, with the knee joint accounting for more than 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 the private sector and government, with a low rate of reported funding from industry partners.

Clinical relevance: Identifying existing needs in the current market may help increase rates of research funding or optimize current funding pathways, in this study, specifically for targeting unaddressed focus areas in OA research. Our systematic review highlights the potential need for additional research and development regarding OA preventative and disease-modifying therapies.