利益相关者对埃塞俄比亚审判后准入安排的看法:一项定性研究。

Q1 Arts and Humanities
Global Bioethics Pub Date : 2025-05-05 eCollection Date: 2025-01-01 DOI:10.1080/11287462.2025.2497599
Gudina Terefe Tucho, Cynthia Khamala Wangamati, Diribe Makonene Kumsa, Rosemarie de la Cruz Bernabe
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引用次数: 0

摘要

虽然在低收入和中等收入国家的临床试验中,关于试验后获取(PTA)的实践经验和指导有限,但利益分享的概念已在国际伦理准则中牢固确立。尽管优惠贸易区在分配正义方面很重要,但在撒哈拉以南非洲很少进行关于优惠贸易区的研究。本研究旨在探讨利益相关者对PTA的看法及其在埃塞俄比亚的可行性。采用深度访谈法对参与临床试验研究与回顾的22位利益相关者进行了探索性质的研究。采用演绎主题分析法对数据进行分析。我们发现研究参与者对PTA的了解有限。他们认为,试验参与者和社区都应从临床试验中受益,而多方利益相关者的合作是PTA规划和安排的关键。但是,他们不确定在埃塞俄比亚实行优惠贸易区的可行性,主要是由于缺乏关于优惠贸易区的立法、条例和准则,以及担心失去赞助者,因为它们有义务提供优惠贸易区而增加费用。建议埃塞俄比亚制定立法和准则来管理优惠贸易区。多方利益相关者参与PTA的规划和安排是PTA有意义的关键,因为责任是由各方共同承担的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Perspectives of stakeholders on post-trial access arrangements in Ethiopia: a qualitative study.

While there is limited practical experience and guidance on post-trial access (PTA) in clinical trials in low- and middle-income countries, the concept of benefit-sharing is firmly established in international ethical guidelines. Few studies have been conducted in sub-Saharan African on PTA despite its importance in distributive justice. This study aims to explore the stakeholders' perspectives on PTA and its feasibility in Ethiopia. An exploratory qualitative study using in-depth interviews was conducted with 22 stakeholders involved in clinical trials study and review. Deductive thematic analysis was used to analyze the data. We found that research participants had limited knowledge on PTA. They opined that both trial participants and communities should benefit from clinical trials and multi-stakeholder collaboration was key in PTA planning and arrangements. However, they were uncertain of PTA feasibility in Ethiopia mostly due to a lack of legislation, regulations and guidelines on PTA and fear of losing sponsors because of increased costs resulting from them being obligated to provide PTA. It was recommended that Ethiopia establishes legislation and guidelines to govern PTA. Multi-stakeholder engagement in PTA planning and arrangements is key for meaningful PTA as the responsibility is shouldered by all parties.

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来源期刊
Global Bioethics
Global Bioethics Arts and Humanities-Philosophy
CiteScore
5.00
自引率
0.00%
发文量
12
审稿时长
37 weeks
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