Sigston Elizabeth A W
Monash Institute of Medical Engineering, Monash University, Melbourne, VIC, Australia.
Department of Surgery, School of Clinical Sciences at Monash Health, Monash University Melbourne, Melbourne, VIC, Australia.
Front Bioeng Biotechnol. 2021 Dec 10;9:640611. doi: 10.3389/fbioe.2021.640611. eCollection 2021.
"Translational Research" has traditionally been defined as taking basic scientific findings and developing new diagnostic tools, drugs, devices and treatment options for patients, that are translated into practice, reach the people and populations for whom they are intended and are implemented correctly. The implication is of a unidirectional flow from "the bench to bedside". The rapidly emergent field of additive manufacturing (3D printing) is contributing to a major shift in translational medical research. This includes the concept of bidirectional or reverse translation, early collaboration between clinicians, bio-engineers and basic scientists, and an increasingly entrepreneurial mindset. This coincides with, and is strongly complemented by, the rise of systems biology. The rapid pace at which this type of translational research can occur brings a variety of potential pitfalls and ethical concerns. Regulation surrounding implantable medical devices is struggling to keep up. 3D printing has opened the way for personalization which can make clinical outcomes hard to assess and risks putting the individual before the community. In some instances, novelty and hype has led to loss of transparency of outcomes with dire consequence. Collaboration with commercial partners has potential for conflict of interest. Nevertheless, 3D printing has dramatically changed the landscape of translational research. With early recognition and management of the potential risks, the benefits of reshaping the approach to translational research are enormous. This impact will extend into many other areas of biomedical research, re-establishing that science is more than a body of research. It is a way of thinking.
“转化医学研究”传统上被定义为获取基础科学研究成果,并为患者开发新的诊断工具、药物、设备及治疗方案,这些成果要转化为实际应用,惠及目标人群并得到正确实施。这意味着从“实验室到临床”的单向流程。快速兴起的增材制造(3D打印)领域正在推动转化医学研究发生重大转变。这包括双向或反向转化的概念、临床医生、生物工程师和基础科学家之间的早期合作,以及日益增强的创业思维。这与系统生物学的兴起相契合,并得到其有力补充。这类转化医学研究能够迅速开展,这带来了各种潜在的陷阱和伦理问题。围绕植入式医疗设备的监管难以跟上步伐。3D打印为个性化开辟了道路,这可能使临床结果难以评估,并且存在将个体置于群体利益之上的风险。在某些情况下,新奇性和炒作导致结果缺乏透明度,产生了严重后果。与商业伙伴的合作存在利益冲突的可能性。尽管如此,3D打印已经极大地改变了转化医学研究的局面。通过尽早识别和管理潜在风险,重塑转化医学研究方法的益处是巨大的。这种影响将延伸到生物医学研究的许多其他领域,再次证明科学不仅仅是一系列研究,更是一种思维方式。