Comparative effectiveness research – How effective is it for vulnerable populations?

Comparative effectiveness research has received much attention, and money, in the stimulus package of 2009. The idea of using studies to determine the most effective drug or device seems a quite effective form of health care reform, but when studies are done without ensuring participation of persons with disabilities or other groups which might be disproportionately impacted, what effect should this have on policy? The Consortium for Citizens with Disabilities (CCD), which represents over 120 organizations representing persons with disabilities and their families, has expressed support for the idea of CER. While this organization has supported CER, the question remains how to best utilize this process to the advantage of those who might be underrepresented in clinical trials or utilize multiple treatments at one time. This talk examines different possibilities such as: prohibiting results from being utilized by payment companies as the primary reason to decline coverage, marketing results to the public rather than payers, consideration of special populations when using double blind studies as “gold standard”, among others. A discussion of the ethics and possible regulatory solutions will be included.