Abstract
BackgroundThe $1.1 billion investment in comparative effectiveness research will reshape the evidence-base supporting decisions about treatment effectiveness, safety, and cost. Defining the current prevalence and characteristics of comparative effectiveness (CE) research will enable future assessments of the impact of this program.MethodsWe conducted an observational study of clinical trials addressing priority research topics defined by the Institute of Medicine and conducted in the US between 2007 and 2010. Trials were identified in ClinicalTrials.gov. Main outcome measures were the prevalence of comparative effectiveness research, nature of comparators selected, funding sources, and impact of these factors on results.Results231 (22.3%; 95% CI 19.8%–24.9%) studies were CE studies and 804 (77.7%; 95% CI, 75.1%–80.2%) were non-CE studies, with 379 (36.6%; 95% CI, 33.7%–39.6%) employing a placebo control and 425 (41.1%; 95% CI, 38.1%–44.1%) no control. The most common treatments examined in CE studies were drug interventions (37.2%), behavioral interventions (28.6%), and procedures (15.6%). Study findings were favorable for the experimental treatment in 34.8% of CE studies and greater than twice as many (78.6%) non-CE studies (P<0.001). CE studies were more likely to receive government funding (P = 0.003) and less likely to receive industry funding (P = 0.01), with 71.8% of CE studies primarily funded by a noncommercial source. The types of interventions studied differed based on funding source, with 95.4% of industry trials studying a drug or device. In addition, industry-funded CE studies were associated with the fewest pediatric subjects (P<0.001), the largest anticipated sample size (P<0.001), and the shortest study duration (P<0.001).ConclusionsIn this sample of studies examining high priority areas for CE research, less than a quarter are CE studies and the majority is supported by government and nonprofits. The low prevalence of CE research exists across CE studies with a broad array of interventions and characteristics.
Highlights
Comparative effectiveness (CE) research is the ‘‘generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor health conditions in ‘real world’ settings’’.[1]
In the United States, comparative effectiveness (CE) research was recently appropriated $1.1 billion through the American Recovery and Reinvestment Act of 2009.[1,8] This funding reflects the growing awareness that improved data is needed on the relative benefits of therapies to enable patients and clinicians to make informed decisions and to reduce gross geographic variations in healthcare allocations seen across the United States.[9,10]
We examine research areas highlighted in the 2009 Institute of Medicine (IOM) list of 100 priority topics deemed to be most pertinent to improving the health of the population, commissioned by the United States Congress to inform the initial investment in CE research.[11]
Summary
Comparative effectiveness (CE) research is the ‘‘generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor health conditions in ‘real world’ settings’’.[1]. We examine research areas highlighted in the 2009 Institute of Medicine (IOM) list of 100 priority topics deemed to be most pertinent to improving the health of the population, commissioned by the United States Congress to inform the initial investment in CE research.[11] Since we focus on research activity in the United States, we limit our study to trials registered in ClinicalTrials.gov, which is the primary registry employed by investigators in the United States and which has previously been used to define and study large trial cohorts.[12,13] To begin to anticipate the impact of the investment in CE research, we determine the prevalence of CE research to date, the types of interventions studied, and the role of funding sources sponsoring CE research. Defining the current prevalence and characteristics of comparative effectiveness (CE) research will enable future assessments of the impact of this program
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