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AdvaMed drafts principles for comparative effectiveness research

Device Regulation Alert: Safety, Compliance and Reimbursement News, November 19, 2007

Concerned about use of comparative effectiveness research concerning medical devices and drugs, AdvaMed issued a set of principles it hopes will guide Congress and others in using information gained from such research.

According to AdvaMed's October 24 press release, comparative effectiveness research reviews effectiveness of alternative treatments and may consider what treatments work "on average across a population." AdvaMed expressed concern that this research could focus too much on cost-effectiveness rather than on the clinical effectiveness of treatments. AdvaMed asserted that such research shouldn't be used to deny coverage or otherwise limit access to drugs, devices, or technologies.

AdvaMed supports comparative effectiveness research and praised its ability to help physicians and patients compare the advantages and disadvantages of various treatment alternatives. Therefore, AdvaMed released a set of principles to help ensure providers and legislators conduct and use comparative effectiveness research appropriately.

According to AdvaMed's principles, comparative effectiveness research should:

• help, rather than interfere with, independent and professional medical decision-making
• promote patient access to treatment and not be used to deny coverage
• include studies of health system issues such as electronic medical records, ways to avoid medical errors, and discharge planning
• include the medical community, manufacturers, patients, and others in determining research priorities and the issues to be studied
• study a time period appropriate to each device or treatment being reviewed
• focus government-sponsored research only on clinical effectiveness
• account for the unique challenges and timing of medical device development
• involve all concerned parties in structuring and conducting the research including patients, hospitals, providers, device industry, and others
• consider all the benefits of a treatment or device including quality of life, safety for healthcare workers, and other factors
• inform personalized treatment decisions and not dictate treatment
• result in clear reporting of the research results acknowledging any limitations and any assumptions made
• involve Congressional or executive branch oversight for government-funded research

Click here to review AdvaMed's principles.

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