Department of Biomedical Sciences, College of Veterinary Medicine and Animal Sciences, University of Gondar, P.O. Box: 196, Gondar, Ethiopia.
Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, P.O. Box 9086, Addis Ababa, Ethiopia.
BMC Med Res Methodol. 2024 Sep 19;24(1):211. doi: 10.1186/s12874-024-02338-8.
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.
尽管转化研究的目标是将生物医学知识从实验室转化为临床试验和治疗产品，以改善健康，但由于不同国家记录的许多障碍，这一目标并没有像预期的那样经常实现。因此，本研究旨在探讨在埃塞俄比亚将动物研究转化为人体试验的挑战和机遇。
采用描述性定性研究方法，通过深入访谈，邀请参与动物研究或临床试验的主要研究者参与。使用归纳主题过程进行数据分析。
出现了六个挑战主题：缺乏财务和人力资源、基础设施不足、运营障碍和较差的研究治理、缺乏合作、结果不可重现以及延长伦理和监管审批流程。此外，还综合了三个机遇主题：不断增长的基础设施和资源、提高的人力和更好的行政流程以及合作倡议。
研究发现，所确定的特征/特点对于阻碍或促进将动物研究转化为人体试验的实践非常重要。研究表明，应该有足够的基础设施和资金、人力资源建设、良好的研究治理、改进的伦理和监管审批流程、多学科合作以及为研究人员提供激励和认可，以克服所确定的挑战，并允许更有效地将动物研究转化为人体试验。
