1、1850 单词， 1 万英文字符， 3300 汉字 出处： Hamburg M A, Collins F S. The path to personalized medicineJ. New England Journal of Medicine, 2010, 363(4): 301-304. The Path to Personalized Medicine Margaret A. Hamburg, Francis S. Collins Major investments in basic science have created an opportunity for significant
2、 progress in clinical medicine. Researchers have discovered hundreds of genes that harbor variations contributing to human illness, identified genetic variability in patients responses to dozens of treatments, and begun to target the molecular causes of some diseases. In addition, scientists are dev
3、eloping and using diagnostic tests based on genetics or other molecular mechanisms to better predict patients responses to targeted therapy. The challenge is to deliver the benefits of this work to patients. As the leaders of the National Institutes of Health (NIH) and the Food and Drug Administrati
4、on (FDA), we have a shared vision of personalized medicine and the scientific and regulatory structure needed to support its growth. Together, we have been focusing on the best ways to develop new therapies and optimize prescribing by steering patients to the right drug at the right dose at the righ
5、t time. We recognize that myriad obstacles must be overcome to achieve these goals. These include scientific challenges, such as determining which genetic markers have the most clinical significance, limiting the off-target effects of gene-based therapies, and conducting clinical studies to identify
6、 genetic variants that are correlated with a drug response. There are also policy challenges, such as finding a level of regulation for genetic tests that both protects patients and encourages innovation. To make progress, the NIH and the FDA will invest in advancing translational and regulatory science, better define regulatory pathways for coordinated approval of codeveloped diagnostics and therapeutics, develop risk-based approaches for appropriate review of diagnostics to more accuratel
