埃塞俄比亚将动物研究转化为人体试验的挑战与机遇

IF 3.9 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES BMC Medical Research Methodology Pub Date : 2024-09-19 DOI:10.1186/s12874-024-02338-8
Askale Abrhaley, Mirutse Giday, Asrat Hailu
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引用次数: 0

摘要

虽然转化研究的目标是将生物医学知识从实验室带入临床试验和治疗产品,以改善健康状况,但由于不同国家存在许多障碍,这一目标并未如愿实现。因此,本研究旨在调查埃塞俄比亚将动物研究转化为人体试验所面临的挑战和机遇。本研究采用深入访谈的方式,对临床前和临床试验研究人员进行了描述性定性研究,他们作为主要研究人员参与了动物研究或临床试验。研究人员采用归纳主题法对数据进行了分析。得出了六个挑战主题:缺乏财力和人力、基础设施不足、操作障碍和研究管理不善、缺乏合作、结果缺乏可重复性以及伦理和监管审批流程冗长。此外,还归纳出三个机遇主题:不断增长的基础设施和资源、更强的人 力、更好的行政程序以及促进合作的举措。研究发现,已确定的特点/特征对于将动物研究转化为人体试验的实践具有重要的阻碍或促进作用。研究建议,应提供充足的基础设施和资金、人员能力建设、良好的研究管理、改进的伦理和监管审批程序、多学科合作以及对研究人员的激励和认可,以克服已确定的挑战,使动物研究转化为人体试验的工作更有效地进行。
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Challenges and opportunities of translating animal research into human trials in Ethiopia
Although the goal of translational research is to bring biomedical knowledge from the laboratory to clinical trial and therapeutic products for improving health, this goal has not been well achieved as often as desired because of many barriers documented in different countries. Therefore, the aim of this study was to investigate the challenges and opportunities of translating animal research into human trials in Ethiopia. A descriptive qualitative study, using in-depth interviews, was conducted in which preclinical and clinical trial researchers who have been involved in animal research or clinical trials as principal investigator were involved. Data were analyzed using inductive thematic process. Six themes were emerged for challenges: lack of financial and human capacity, inadequate infrastructure, operational obstacles and poor research governance, lack of collaboration, lack of reproducibility of results and prolonged ethical and regulatory approval processes. Furthermore, three themes were synthesized for opportunities: growing infrastructure and resources, improved human capacity and better administrative processes and initiatives for collaboration. The study found that the identified characteristics/features are of high importance either to hurdle or enable the practice of translating animal research into human trials. The study suggests that there should be adequate infrastructure and finance, human capacity building, good research governance, improved ethical and regulatory approval process, multidisciplinary collaboration, and incentives and recognition for researchers to overcome the identified challenges and allow translating of animal research into human trials to proceed more efficiently.
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来源期刊
BMC Medical Research Methodology
BMC Medical Research Methodology 医学-卫生保健
CiteScore
6.50
自引率
2.50%
发文量
298
审稿时长
3-8 weeks
期刊介绍: BMC Medical Research Methodology is an open access journal publishing original peer-reviewed research articles in methodological approaches to healthcare research. Articles on the methodology of epidemiological research, clinical trials and meta-analysis/systematic review are particularly encouraged, as are empirical studies of the associations between choice of methodology and study outcomes. BMC Medical Research Methodology does not aim to publish articles describing scientific methods or techniques: these should be directed to the BMC journal covering the relevant biomedical subject area.
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