- Sean R Tunis, executive director1,
- Steven D Pearson, president2
- 1Center for Medical Technology Policy, Baltimore, MD 21210, USA
- 2Institute for Clinical and Economic Review, Massachusetts General Hospital, Boston, MA, USA
- Correspondence to: S R Tunis
- Accepted 30 June 2010
One of the provisions of the recent US health reform legislation was to create a national Patient-Centered Outcomes Research Institute. The institute, which will be an independent non-profit organisation, will guide the expansion of comparative effectiveness research.1 It will be overseen by a multistakeholder governing board to be appointed by September 2010, with public and private funding rising above $500m (£330m; €400m) a year by 2014.
Expanding the national capacity to generate better evidence to guide decision making seems uncontroversial, but research into comparative effectiveness rapidly became a lightning rod for intense debate. The new institute will soon be launched in a political atmosphere still smouldering with distrust and anger. We describe the central issues and controversies in the debate, explain how they were dealt with in the health reform law, and discuss the critical steps that will be needed to allow the new institute to meet its high expectations.
What is comparative effectiveness research?
Comparing risks and benefits of alternative healthcare strategies has been a longstanding goal of clinical research and health technology assessment, and it is also fundamental to comparative effectiveness research. The discipline uses a wide range of methods including syntheses of existing evidence, analyses of routinely collected data, and the generation of new evidence through prospective registries and clinical trials. The key defining characteristic of comparative effectiveness research is that its explicit purpose is to generate evidence that will help patients, clinicians, and health insurers make more informed clinical and health policy decisions.2 This is the first time that a large research portfolio specifically dedicated to the information needs of decision makers has …