Stimulus-Funded CER: Few Awards Are For Drug Vs. Drug Studies
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Pitting one drug against another proved not to be a key focus of the comparative effectiveness research funding given from the $1.1 billion set aside for CER in the American Recovery and Reinvestment Act. According to recent analysis from Avalere Health, 38% of the 422 total awards (including both grants and contracts) provided out of ARRA as of September 30 were earmarked for evidence development. Avalere found that 16% of projects are generating drug vs. drug comparative evidence and another 11% are focused on drug vs. non-drug interventions. Those figures are based on an analysis of 134 evidence development awards that had an abstract available and did not specifically involve "horizon scanning" (identifying where there are gaps in information or there is information emerging, rather than actually evaluating services). The majority of contracts in the evidence development category are for non-drug vs. non-drug interventions (40%) and health care delivery system comparisons (32%).
Types of ARRA CER Awards
“That was expected by us for the simple reason that if you take a look at the stakeholder input both at the [Federal Coordinating Committee for Comparative Effectiveness Research] testimony as well as the [Institute of Medicine] priorities and the input that they received, the priorities that they identified were two kinds: one was that you needed to focus on interventions that were much broader than just drug versus drug, and I think that is reflected,” Riaz Ali, director of the Avalere Center for Evidence Based Medicine, said in an interview. “But more importantly, what I think they were also saying was that you needed to invest a lot more in the infrastructure to build out a more sustainable apparatus to conduct CER,” Ali continued. “So the thought that there are registries to fuel multiple kinds of studies, the fact that there is a focus on dissemination and translation of evidence, all of those things were higher priorities than amplifying the amount of research on drugs versus drugs.” In fact, of the 422 awards, 46% were given for infrastructure and methods development, according to the Avalere analysis. The remaining 16% went for translation and dissemination of comparative effectiveness research. The Federal Coordinating Council and the IoM both provided recommendations on how to spend the allocated funds in the stimulus act that primarily focused on infrastructure development (Also see "Comparative Effectiveness Infrastructure Is Priority, Federal Advisors Say" - Pink Sheet, 6 Jul, 2009.).
Types Of ARRA CER Evidence Generation Awards
This lack of emphasis on drug versus drug comparative trials is expected to continue when the Patient-Centered Outcomes Research Institute begins funding research (Also see "CER To Play A Larger Role In Investment Decisions – Merck's McElwee" - Pink Sheet, 20 Sep, 2010.). Cardiovascular Is Lead Therapeutic Group In looking at the 422 total awards given out by the Agency for Healthcare Research and Quality (82), the Department of Health and Human Services (121) and the National Institutes of Health (219), the lead therapeutic area to receive attention is cardiovascular and peripheral disease, with 13% of the awards. Following that is oncology and hematology (10%) and endocrinology, metabolic disorders and geriatrics (5%). The focus on these therapeutic areas also did not surprise Ali. “The other thing that I would say that was noteworthy, but I wouldn’t characterize as a surprise, is that when you did actually kind of take a look at some of the therapeutic level interventions, which investments are actually focused on therapies, the focus on cardiovascular and on oncology and then the endocrinology space as sort of the top three didn’t surprise us,” Ali said “Those are perfectly in line with where the IoM was focused, perfectly in line with all of the other CER investments to date.” |