在临床试验中建立信任的策略:加纳定性研究中利益相关者的观点。

PLOS global public health Pub Date : 2025-04-08 eCollection Date: 2025-01-01 DOI:10.1371/journal.pgph.0003201
Samuel Tamti Chatio, John Kuumuori Ganle, Philip Baba Adongo, Patrick Odum Ansah, Engelbert A Nonterah, Nathan Kumasenu Mensah, James Akazili, Ulrike Beisel
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引用次数: 0

摘要

虽然临床试验随着时间的推移不断发展和改进,在疾病的诊断、治疗和预防方面取得了重大进展,但同样存在一些关键挑战,例如一些临床试验的可行性,最重要的是对进行临床试验的信任问题。因此,本研究为解决与临床试验行为相关的挑战提供了科学证据,并提供了一个框架,描述了适当的信任建立策略,以指导加纳及其他地区未来临床试验研究的开展。该研究采用定性研究方法,在2019年6月至8月期间对参与者进行了48次深度访谈和关键信息提供者访谈。在主题内容分析之前,使用QSR Nvivo 12软件对访谈进行记录、转录并编码为主题。结果显示,在加纳进行临床试验的信任度较低。与会者建议了几项建立信任的策略,以改善整个临床试验周期的信任。建议实施前战略,如有效的利益相关者参与和加强临床试验监管机构,以建立社区信任。强烈建议采取实施战略,如有效监测、解决关于采集和使用血液样本的不可信问题和误解、改进知情同意程序以及实施后战略,如及时向临床试验社区反馈,以建立对临床试验行为的信任。信任是影响临床试验进行的一个重要因素,特别是在发展中国家。通过利益攸关方的适当参与和临床试验监管机构的有效监测系统,投资于国家和社区一级建立信任的活动,是提高对临床试验行为信任的关键战略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Strategies to build trust in the conduct of clinical trials: Stakeholders' views in a qualitative study in Ghana.

While clinical trials have evolved and improved over time producing significant advances in diagnosis, treatment and prevention of diseases, there are equally key challenges such as feasibility of some clinical trials and most importantly the issue of trust in the conduct of clinical trials. Thus, this study provides scientific evidence to address challenges associated with clinical trials conduct as well as a framework describing appropriate trust building strategies to guide the conduct of future clinical trial studies in Ghana and beyond. The study used qualitative research approach where 48 in-depth and Key informant interviews were conducted with participants between June and August, 2019. The interviews were recorded, transcribed and coded into themes using QSR Nvivo 12 software before thematic content analysis. The results revealed low level of trust in the conduct of clinical trials in Ghana. Participants recommended several trust building strategies to improve trust across the clinical trial cycle. Pre-implementation strategies such as effective stakeholder engagement and strengthening clinical trial regulatory bodies were recommended to build community trust. Implementation strategies such as effective monitoring, addressing issues of untrustworthiness and misconceptions regarding drawing and use of blood samples, improved informed consent procedures as well as post-implementation strategy such as timely feedback to clinical trial communities were highly recommended to build trust in clinical trials conduct. Trust is an important factor affecting clinical trials conduct especially in developing countries. The need to invest in national and community level trust-building activities through appropriate stakeholder engagement and effective monitoring systems by clinical trial regulatory bodies are critical strategies to improve trust in clinical trials conduct.

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