背景:将医学研究转变为现实世界的医疗保健解决方案是一项复杂的工作,可能会受益于学术研究之间的协同作用,政府支持,和行业创新。
目的:在本文中,我们深入研究了巴西的转化医学研究(TMR)框架,阐明公立大学和其他关键利益相关者在转化过程中可能的相互作用。
方法:我们的焦点是Rapha®设备,一种创新的医疗技术,当我们探索它的道德和监管之旅。我们寻求通过混合方法研究设计来了解塑造医疗技术发展的环境,将政策分析与利益相关者访谈相结合。
结果:研究开始于研究公共政策,旨在创造一个具有社会包容性和有利的生态系统。然后我们突出关键的组成部分——步骤,里程碑,利益相关者,以及支持TMR进程的政策。我们的研究结果表明,尽管TMR经常以专利和技术转让协议告终,存在特定的监管和生产挑战,特别是在从T3(临床试验)过渡到T4(公共卫生实践)阶段期间。我们通过追踪Rapha®设备从基础研究(T0)到临床试验(T3)的发展阶段,为其转化过程提供见解。
结论:最终,这项研究强调了TMR在推进医疗保健准入方面的重要作用,并认为学术机构可以显著影响道德健壮的创造,受管制,和有影响力的医学创新,为全球医疗保健做出有意义的贡献。
BACKGROUND: Transforming medical research into real-world healthcare solutions is a complex endeavor that may benefit from the synergy between academic research, governmental support, and industry innovation.
OBJECTIVE: In this article we delve into the framework of Translational Medical Research (
TMR) in Brazil, elucidating the possible interplay between public universities and other pivotal stakeholders in the translational journey.
METHODS: Our focal point is the Rapha® device, an innovative medical technology, as we explore its ethical and regulatory journey. We seek to understand the environment that shapes healthcare technology development through a mixed-methods research design, combining policy analysis with stakeholder interviews.
RESULTS: The research begins by examining public policies, aiming to carve out a socially inclusive and advantageous ecosystem. We then highlight the pivotal components-steps, milestones, stakeholders, and policies that underpin the
TMR process. Our findings reveal that while
TMR frequently culminates in patents and technology transfer agreements, specific regulatory and production challenges exist, particularly during transitioning from the T3 (clinical trials) to T4 (public health practice) phase. We provide insights into its translational progression by tracing the developmental stages from foundational research (T0) to clinical trials (T3) for the Rapha® device.
CONCLUSIONS: Ultimately, this study underscores
TMR\'s vital role in advancing healthcare access and posits that academic institutions can significantly influence the creation of ethically robust, regulated, and impactful medical innovations, contributing meaningfully to global healthcare.