Defining the balance of risk and benefit in the era of genomics and proteomics.
The ability to measure the function of genes and proteins has spawned the construct of personalized medicine, in which patients' own risks and preferences are used to choose diagnostic and therapeutic strategies. The complexity of clinical data required to guide personalized medicine calls for improvements in our system of clinical research, including (1) overhauling it to produce networks that can do adequate-size pragmatic trials; (2) synchronization of regulatory and payment systems to encourage adequate studies; and (3) an investment in education of providers and patients to improve the understanding of the probabilistic predictions forming the basis of personalized medicine.
Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University Medical Center in Durham, North Carolina, USA.
Robert M
RM
Califf
D002986:Clinical Trials as Topic; D023281:Genomics; D006801:Humans; D040901:Proteomics; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration