What Principles Should Guide Treatment Effectiveness Study?

Value: Value is defined as the best balance between benefits and costs, and better value as improved clinical outcomes, quality, and/or patient satisfaction per dollar spent.

Independence: A federally sponsored CER entity should be an objective, independent authority that produces valid, scientifically rigorous research.

Stable funding: The entity should have secure and sufficient funding to maintain the necessary infrastructure and resources to produce quality CER.

Rigorous scientifically sound methodology: CER should be conducted using rigorous scientific methods to ensure that conclusions from such research are evidence-based and valid for the population studied.

Transparent process: The processes for setting research priorities, establishing accepted methodologies, selecting researchers or research organizations, and disseminating findings must be transparent and provide physicians and researchers a central and significant role.

Significant patient and physician oversight role: The oversight body of the CER entity must provide patients, physicians—including clinical practice physicians—and independent scientific researchers with substantial representation and a central decision-making role.

Conflicts of interest disclosed and minimized: All conflicts of interest must be disclosed and safeguards developed to minimize actual, potential, and perceived conflicts of interest to ensure that stakeholders with such conflicts of interest do not undermine the integrity and legitimacy of the research findings and conclusions.

Scope of research: Diagnostic and treatment modalities should include drugs, biologics, imaging and laboratory tests, medical devices, health services, or combinations. It should not be limited to new treatments.... The priority areas of CER should be on high volume, high-cost diagnosis, treatment, and health services for which there is significant variation in practice.

Dissemination of research: The CER entity must work with health care professionals and health care professional organizations to effectively disseminate the results of studies in a timely manner by significantly expanding dissemination capacity and intensifying efforts to communicate to physicians utilizing a variety of strategies and methods.

Coverage and payment: The CER entity must not have a role in making or recommending coverage or payment decisions for payers.

Patient variation and physician discretion: Physician discretion in the treatment of individual patients remains central to the practice of medicine.