Training OPportunities in Translational Imaging Education and Research (TOP-TIER)

项目摘要 精准医疗正在成为一种疾病治疗和预防的方法， 考虑到基因、环境和生活方式的个体差异。虽然在精确度方面取得了一些有限的进展， 尽管在肿瘤学领域已经制造了精确医学，但精确医学还没有广泛应用。精度 医学已经成为美国国立卫生研究院（NIH）及其合作伙伴的一项倡议。发展 患者特异性生物标志物成像的方法，以指导和监测患者特异性治疗， 需要推进NIH的这项新计划训练有素的医生科学家队伍是采取行动的关键 这些新发展的优势。精密成像的进步是跨学科的技术 跨越物理、计算和生物科学的创新。这些研究始于 使用基于靶向病理学的成像进行临床前机制研究，然后扩展到人类 科目人体研究包括安全性测试和美国食品药品监督管理局（FDA） 研究性新药（IND）和器械豁免（IDE）流程。最终目的是为了研究 创新广泛提供给公众和整个执业医学界，通过 商业化虽然这种“从板凳到床边”的过程受到了广泛的赞誉，但仍然存在一个问题， 医学成像研究界关于如何将临床前研究纳入 以及如何将这些创新推向大众。此外，临床科学家-居民和 研究员-往往缺乏了解导航研究监管要求以及 知识库，以了解或执行临床前研究，将告知创新机制。 一个全新的教育和创造性的范例需要更好地准备未来的成像科学家 美国国立卫生研究院精准医学计划的挑战。医生-科学家跨学科小组 必须在生物学、技术和医学的界面上共同工作，医生必须 接受教育，通过FDA监管程序将创新带入人类受试者， 通过商业化。在这个应用程序中，我们提出了一个不同于任何其他教育的模型， 为居民和其他医生，科学家，将为他们提供为期两年的培训计划，包括 （a）必修课程（第一年），不仅包括道德、监管和实践方面的培训， 成像研究的各个方面，但也有创新翻译的技能，以及B）专门的翻译 影像学研究（第2年）在高度熟练的成像临床前和临床医生的指导下 科学家考虑到这些需求和目标，我们提出了TOP-TIER（培训机会， 翻译成像教育和研究），临床医生-科学家博士后培训计划，在 位于圣路易斯的华盛顿大学（WU）准备住院医师和其他学员， 将创新应用于患者和医学实践。

PROJECT SUMMARY Precision medicine is emerging as an approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle. While some limited advances in precision medicine have been made in the field of oncology, precision medicine is not in broad practice. Precision medicine has become an initiative of the National Institutes of Health (NIH) and its partners. Development of methods of patient-specific biomarker imaging to guide and monitor patient-specific therapies will be needed to move forward this new NIH initiative. A trained physician-scientist workforce is key to taking advantage of these new developments. Precision imaging advances are interdisciplinary with technology innovations crossing the physical, computational, and biological sciences. These studies start with preclinical mechanistic inquiries using targeted pathology-based imaging and then expand into human subjects. Human studies include safety testing and the Food and Drug Administration's (FDA) Investigational New Drug (IND) and Device Exemption (IDE) process. The ultimate goal is to make research innovations widely available to the public and the entire practicing medical community through commercialization. Although this “bench-to-bedside” process has been widely acclaimed, there remains a knowledge gap in the medical imaging research community as to how to take preclinical research into humans, and how to then take these innovations to the public. Moreover, clinical scientists – residents and fellows – often lack the understanding to navigate research regulatory requirements as well as the knowledge base to understand or perform preclinical research that will inform the mechanism of innovation. A completely new educational and creative paradigm is required to better prepare future imaging scientists for the challenges of the NIH Precision Medicine Initiative. Interdisciplinary teams of physician-scientists must work together at the interfaces of biology, technology, and medicine, and physicians must be educated to work to bring innovation through the FDA regulatory processes, into human subjects and to the public through commercialization. In this application, we propose a model of education unlike any other for resident and fellow physician-scientists that will provide them with a two-year training program consisting of a) a required curriculum (year 1) that covers not only training in the ethics, regulatory and practical aspects of imaging research, but also a skill set for innovation translation, and b) dedicated translational imaging research (year 2) under the mentorship of highly-accomplished imaging pre-clinical and clinician scientists. With these needs and goals in mind, we are proposing TOP-TIER (Training OPportunities in Translational Imaging Education and Research), a clinician-scientist post-doctoral training program at Washington University (WU) in St. Louis to prepare resident and fellow trainees to bring preclinical imaging innovations into patients and to the practice of medicine.