Lupatini Evandro de Oliveira, Zimmermann Ivan Ricardo, Barreto Jorge Otávio Maia, Nunes da Silva Everton
Graduate Program for Collective Health, Faculty of Health Sciences, University of Brasília, Campus Darcy Ribeiro, Asa Norte, Brasília, Brazil.
Departament of Collective Health, Faculty of Health Sciences, University of Brasília, Campus Darcy Ribeiro, Asa Norte, Brasília, Brazil.
Ann Transl Med. 2022 Jul;10(13):738. doi: 10.21037/atm-22-397.
The literature reports long time lags between the several processes involved in the translation of drug research and development into clinical application. To expedite these processes, translational research has emerged as a process that can be applied to reduce the lag between scientific discoveries and their practical application. Thus, the objective of this study was to estimate the time lag in translational research of biological drugs for the treatment of rheumatoid arthritis included in the Brazilian Unified Health System [ (SUS)].
A descriptive retrospective study was conducted based on secondary data loaded by SUS users in public sources and systems to estimate the time lag between the publication of phase I clinical trial results to drug use in clinical settings. The dates of translational research activities were identified from markers and steps. Structured searches were conducted in the literature and reports from the National Commission for the Incorporation of Technologies in the SUS (Conitec) as well as from health authorities, and analyzed.
Between 2012 and 2019, SUS included five biological agents for the treatment of rheumatoid arthritis. The mean time lag from clinical development to use of these agents was 11.13 years (range, 8.57 to 12.90 years). The mean time lag for the stages of translational research were 5.30 (T1-basic research to clinical research), 5.08 (T2-clinical research to research synthesis), and 0.75 (T3-research synthesis to evidence-based practice) years. A shorter time lag was observed in the Brazilian case when it was possible to compare with other studies.
The estimated time lag of biological drugs used in the treatment of rheumatoid arthritis was determined based on the translational research steps model adapted to the Brazilian context. Brazil has instituted legal frameworks that set deadlines for sanitary registration, health technology assessment (HTA), and the availability of drugs in the SUS, thus, allowing for a reduced stage T2 time lag. Nevertheless, improvements are still required in stages T1 and T2, especially in publishing the results of clinical trials.
文献报道了药物研发转化为临床应用所涉及的几个过程之间存在较长的时间滞后。为加快这些过程，转化研究应运而生，它可用于缩短科学发现与其实际应用之间的滞后时间。因此，本研究的目的是估计巴西统一卫生系统（SUS）中用于治疗类风湿关节炎的生物药物转化研究中的时间滞后情况。
基于SUS用户在公共来源和系统中加载的二手数据进行描述性回顾性研究，以估计从I期临床试验结果发表到临床环境中药物使用之间的时间滞后。从标志物和步骤中确定转化研究活动的日期。在文献以及国家技术纳入SUS委员会（Conitec）和卫生当局的报告中进行结构化检索并分析。
2012年至2019年期间，SUS纳入了五种用于治疗类风湿关节炎的生物制剂。从临床开发到这些制剂使用的平均时间滞后为11.13年（范围为8.57至12.90年）。转化研究各阶段的平均时间滞后分别为5.30年（T1 - 基础研究到临床研究）、5.08年（T2 - 临床研究到研究综合）和0.75年（T3 - 研究综合到循证实践）。与其他研究进行比较时，巴西案例中的时间滞后较短。
用于治疗类风湿关节炎的生物药物的估计时间滞后是基于适用于巴西情况的转化研究步骤模型确定的。巴西制定了法律框架，为卫生注册、卫生技术评估（HTA）以及SUS中药物的可及性设定了期限，从而缩短了T2阶段的时间滞后。然而，T1和T2阶段仍需改进，特别是在发表临床试验结果方面。
