Researchers, policy makers, insurers, and other stakeholders have voiced enthusiasm about the value of comparative effectiveness research that rigorously evaluates 2 or more drugs or devices. The most recent boost for these efforts has been the US congressional financial stimulus package that contains provisions for $1.1 billion to be devoted to this effort. The appeal of comparative effectiveness research is undeniable. If there is one issue that stakeholders agree about, it is that increasing health care costs are ultimately unsustainable and society needs more value for its money. However, it is not clear that comparative effectiveness research, as it is commonly framed, has a comparative advantage when it comes to improving the US health care system.

If comparative effectiveness research is to succeed, future initiatives will need to

1. generate data prior to the widespread adoption of a drug or treatment;
   
2. link evidence directly to strategies proven to modify clinical practice;
   
3. expand the research agenda far beyond drugs and devices;
   
4. incorporate the principles of comparative effectiveness research throughout the process of US Food and Drug Administration (FDA) approval and regulation; and
5.  examine the costs, as well as the effectiveness, of treatment alternatives.