Browman George P, Vollmann Jochen, Virani Alice, Schildmann Jan
British Columbia Cancer Agency, Vancouver Island Centre, Canada.
The School of Population & Public Health, University of British Columbia, Vancouver, Canada.
Per Med. 2014 Jun;11(4):413-423. doi: 10.2217/pme.14.17.
The evolving vision for personalized medicine (PM) implies a systems approach to the re-organization of healthcare and how we define the boundary between care and research. Calls for scaling PM up to a systems level requires a broad definition of quality not restricted to how the different elements of the system perform (e.g., laboratory quality control, biomarker prediction, biobanking, information systems, data sharing and security, and clinical outcomes) but how these elements work together to optimize population relevant quality indicators - effectiveness, affordability, system sustainability, public confidence and accessibility. Examples of PM-associated information technologies and innovative clinical evaluation methods with a focus on cancer medicine are provided to demonstrate how quality and ethics are inextricably linked to a PM systems approach. While current, traditional ethical standards sometimes challenge the PM approach, PM is challenging us to review ethical standards and improve ethical frameworks to meet new and future realities.
个性化医疗（PM）不断发展的愿景意味着采用系统方法来重新组织医疗保健以及界定医疗与研究之间的界限。将个性化医疗扩展到系统层面的呼声要求对质量进行广泛定义，这不仅限于系统不同要素的运作方式（例如实验室质量控制、生物标志物预测、生物样本库、信息系统、数据共享与安全以及临床结果），还包括这些要素如何协同工作以优化与人群相关的质量指标——有效性、可负担性、系统可持续性、公众信心和可及性。本文提供了以癌症医学为重点的与个性化医疗相关的信息技术和创新临床评估方法的示例，以说明质量和伦理如何与个性化医疗系统方法紧密相连。虽然当前传统伦理标准有时对个性化医疗方法构成挑战，但个性化医疗也促使我们审视伦理标准并改进伦理框架，以适应新的和未来的现实情况。
