Fundação Oswaldo Cruz-Fiocruz, Instituto Oswaldo Cruz, Laboratório de Inovação em Terapias, Ensino e Bioprodutos, Rio de Janeiro, RJ, Brasil.
Mem Inst Oswaldo Cruz. 2022 Mar 21;117:e220001. doi: 10.1590/0074-02760220001. eCollection 2022.
Translational research (TR) is an interdisciplinary branch of the biomedical field that seeks to connect its three supporting pillars: basic research on the bench, the hospital beds and other health system services, and the delivery of products for the well-being and health of the community. Here, we review the five transition stages of the TR spectrum, registering the lessons learned during > 20 years leading to the first clinical trial designed and performed in Brazil for testing a complementary treatment for Chagas disease (CD): the selenium trial (STCC). Lessons learned were: (1) to consider all the TR spectrum since the beginning of the project; (2) to start simultaneously animal studies and translation to humans; (3) to ensure a harmonious interaction between clinical and basic research teams; (4) to include MSc and PhD students only in pre-clinical and basic studies (TR0) or vertical clinical studies using retrospective samples and data (TR1); (5) to identify potential suppliers in the national commercial market for a future final treatment since the pre-clinical stage; (6) to keep an international network of experts as permanent advisers on the project. In the whole process, some perspectives were created: a complementary clinical trial for the opened questions and the construction of a Brazilian clinical CD platform.
转化研究(TR)是生物医学领域的一个跨学科分支,旨在连接其三个支撑支柱:基础研究、医院病床和其他卫生系统服务,以及为社区福祉和健康提供产品。在这里,我们回顾了 TR 谱的五个转化阶段,记录了在领导巴西第一个临床试验以测试恰加斯病(CD)的补充治疗过程中 20 多年来的经验教训:硒试验(STCC)。吸取的经验教训包括:(1)从项目开始就要考虑所有 TR 谱;(2)同时开始动物研究和向人类转化;(3)确保临床和基础研究团队之间的和谐互动;(4)仅在临床前和基础研究(TR0)或使用回顾性样本和数据的垂直临床研究(TR1)中纳入硕士生和博士生;(5)从临床前阶段开始就为未来的最终治疗在国内商业市场上确定潜在的供应商;(6)为项目建立一个由国际专家组成的永久顾问网络。在整个过程中,我们创造了一些视角:为开放性问题构建了一个补充性的临床试验,并构建了一个巴西临床 CD 平台。