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

项目总结 精准医学正在成为一种疾病治疗和预防的方法，它将 考虑到个体在基因、环境和生活方式上的差异。虽然在精度方面有一些有限的进步 医学已经在肿瘤学领域取得了长足的进步，但精准医学并没有广泛应用。精密度 医学已成为美国国立卫生研究院(NIH)及其合作伙伴的倡议。发展 指导和监测患者特定治疗的患者特定生物标志物成像方法的方法将是 需要推进这项新的NIH倡议。一支训练有素的医生-科学家队伍是 利用这些新的发展。精密成像的进步是与技术交叉的学科 跨越物理、计算和生物科学的创新。这些研究始于 使用基于病理学的靶向成像进行临床前机制研究，然后扩展到人类 研究对象。人体研究包括安全测试和食品和药物管理局(FDA)的 研究新药(IND)和设备豁免(IDE)流程。最终的目标是进行研究 公众和整个执业医学界通过以下途径广泛获得创新 商业化。尽管这种从板凳到床边的过程广受好评，但仍有一种 医学影像研究界关于如何开展临床前研究的知识差距 人类，以及如何将这些创新带给公众。此外，临床科学家-住院医生和 研究员-通常缺乏对驾驭研究法规要求以及 了解或执行将为创新机制提供信息的临床前研究的知识库。 为了更好地为未来的成像科学家做好准备，需要一种全新的教育和创新范式 以应对美国国立卫生研究院精准医学计划的挑战。跨学科的内科-科学家团队 必须在生物、技术和医学的界面上共同努力，医生必须 受过教育，致力于通过FDA监管程序将创新带入人类受试者，并 通过商业化向公众开放。在本申请中，我们提出了一种不同于其他任何教育模式的教育模式 对于住院医师和其他内科科学家，这将为他们提供为期两年的培训计划，包括 A)必修课程(一年级)，不仅包括道德、监管和实践方面的培训 影像研究方面，但也是创新翻译的技能集，以及b)专注于翻译 在卓越的临床前和临床医生的指导下进行影像研究(第二年) 科学家。考虑到这些需求和目标，我们建议提供顶级(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，位于 位于圣路易斯的华盛顿大学(吴)为住院医生和其他受训人员准备带来临床前成像 创新转化为患者和医学实践。

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.