Comparative effectiveness research is designed to evaluate which diagnostic and treatment approaches provide the best health and, sometimes, most cost-effective outcomes. Personalized medicine aims to use individual traits, often genetic or biochemical, to guide appropriate care for a patient. A new report from the Lewin Group argues that comparative effectiveness research will be much less valuable if it does not incorporate personalized medicine. (Lewin Paper)
The typical research trial looks at average treatment effect across the study population. This averaging can miss significant differences in effect for subpopulations. Given what we now know about the importance of individual genetic makeup and biochemistry, there is much greater possibility for those subpopulations to exist. If only average treatment effects are examined, many people for who a treatment does not work, or even creates adverse events, will receive it. And in studies which find no significant average treatment effect, there may be subpopulations for whom the treatment does work.
The Lewin report therefore contends that to the greatest extent possible all comparative effectiveness research should identify and test subpopulation effects. This will ultimately allow development of more precise care guidelines. The report also notes the need for good health information systems to facilitate this research and to make its results easily accessible and usable in routine clinical practice. While so much attention is currently focused on reform of the health coverage system, a growing revolution is occurring in actual medical care, a revolution springing from the continued rapid advance of genomic knowledge. The Lewin report acknowledges the importance of incorporating this new approach into research about the most effective and appropriate care.