, Volume 8, Issue 1, pp 68-69
Date: 23 Dec 2011

Study Methodologies for Osteoarthritis: Clinical Trials and Tribulations

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Introduction

Clinical trials represent the most rigorous approach to evaluating the efficacy of interventions. The clinical trial is a relatively young methodology, used rarely until the middle of the twentieth century. Most clinical trials evaluate medications. In fact a review of clinicaltrials.gov in 2011 indicated that of more than 100,000 registered trials, over 70% were drug trials [1]. The remainder was divided among devices, surgery, and behavioral and educational interventions. While drug trials are important for development of therapeutics in osteoarthritis, trials of surgery, devices, and educational and behavioral interventions are critical as well.

Typical Clinical Trial Methodologies

Most of the methodology for clinical trials was developed for evaluation of medications. Other types of interventions pose unique challenges to the clinical trial paradigm. Table 1 lists five methodological considerations (standardization, concealment, contamination, equipoise, and crossover) an