AHRQ's comparative clinical effectiveness research, authorized by the Medicare Modernization Act, should invoke a broader range of data than most randomized controlled trials currently offer, AdvaMed contends.

"While it is universally acknowledged that well-designed randomized clinical trials can provide highly valuable evidence regarding efficacy of healthcare services, they often study only a very narrow range of endpoints among those that are important to patients, physicians and the country as a whole," the association notes in a June 25 letter to the Agency for Healthcare Research & Quality.

Urging a "broad-based approach" toward "evidence collection and evidence review," AdvaMed asks AHRQ to fold into its analysis such factors as quality-of-life, work loss, adherence to therapy, patient preferences, geographic variation, symptom control and outcomes long after a trial concludes.

By focusing largely on HHS' "overall approach" in implementing Sec. 1013 of MMA, AdvaMed is anticipating the possibility that AHRQ's current emphasis on comparative clinical trials for drugs eventually may extend to devices. In April, AHRQ published a notice explaining that its initial priority list likely will address prescription drug effectiveness. Therefore, AdvaMed's recommended research priorities apply to fiscal 2006 and beyond.

In earlier comments to AHRQ, Guidant had suggested cardiovascular care quality for women and carotid artery disease screening as potential research topics (¹ Also see "Carotid Artery Disease Screening Should Make AHRQ Research List – Guidant" - Medtech Insight, 24 May, 2004., p. 20). For its part, Medtronic advocates research on suboptimal care for Type 1 diabetics, and cost barriers that programs such as Medicare/Medicaid may pose to this population.

AdvaMed concurs with its members' proposals, but adds the benefit of health information and monitoring technologies for underserved communities as another priority research item. AHRQ should evaluate the use of such devices in Medicaid disease management programs, even as CMS tracks the progress of its Medicare Chronic Care Improvement Program, beginning in 2005, AdvaMed suggests. The group recently formed a digital health information technology product sector, comprised of member firms.

AdvaMed Urges “Broad-Based Approach” To AHRQ Research

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