Ethical Legal and Social Implications Issues in Comparative Effectiveness Researc

描述（由申请人提供）：两个主要的力量在临床医学的地平线上，预计将改变临床护理的范式。一种是个性化基因组医学（PGM），它试图利用有关个人遗传禀赋的知识来个性化定制特定的医学疗法。当今医疗保健的第二个驱动力是进行比较有效性研究（CER），以直接比较相同疾病或病症的替代疗法或诊断方式的有效性，有时甚至是成本。由于CER是针对PGM的替代方法进行的，因此适当解决基因组研究引起的伦理、法律的和社会问题非常重要，ELSI计划已阐明了这些问题。然而，到目前为止，还没有重大的尝试，以确定如何设计和实施的CER研究PGM应形成的教训，从ELSI计划。本项目旨在通过全面审查个性化基因组医学（CER/PGM）的比较有效性研究所提出的特定伦理，法律的和社会问题，并提出一套在设计和进行这项研究时要考虑的问题，以便以伦理，法律的和社会适当的方式进行。 公共卫生相关性：个性化基因组医学和比较有效性研究正在成为提高医疗保健质量和控制医疗保健成本的越来越重要的工具，预计比较各种个性化基因组干预措施和方法的有效性的研究数量将增加。虽然已经有相当大的努力来理解和解决个性化基因组医学的伦理，法律的和社会影响，很少尝试将这些知识应用于个性化基因组医学的比较有效性研究的设计，实施和翻译。该项目将确定这些问题，并建议如何通过这种类型的研究适当地解决这些问题。

DESCRIPTION (provided by applicant): Two major forces in clinical medicine on the horizon are expected to change the paradigm of clinical care. One is personalized genomic medicine (PGM), which seeks to harness knowledge about the genetic endowment of the individual to individually tailor specific medical therapies. The second driving force in healthcare today is to conduct comparative effectiveness research (CER) to directly compare the effectiveness, and sometimes the cost, of alternative therapies or diagnostic modalities for the same disease or condition. As CER is conducted on alternative approaches to PGM, it is important for it to appropriately address the ethical, legal, and social concerns raised by genomic research, which have been elucidated by the ELSI program. To date, however, there has been no significant attempt to determine how the design and conduct of CER research on PGM should be shaped by the lessons from the ELSI program. This project aims to respond to this gap by comprehensively examining the specific ethical, legal, and social issues raised by comparative effectiveness research on personalized genomic medicine (CER/PGM), and to propose a set of points to consider in designing and conducting this research so that it can be carried out in an ethical, legal, and socially appropriate manner. PUBLIC HEALTH RELEVANCE: Both personalized genomic medicine and comparative effectiveness research are becoming increasingly important tools for improving the quality of health care and controlling health care costs, and the number of studies comparing the effectiveness of various personalized genomic interventions and approaches is expected to grow. While there has been a considerable effort to understand and address the ethical, legal, and social implications of personalized genomic medicine, there has been little attempt to apply this knowledge to the design, conduct, and translation of comparative effectiveness research on personalized genomic medicine. This project will identify these concerns and suggest how they can be appropriately addressed by this type of research.