Chatio Samuel Tamti, Ganle John Kuumuori, Adongo Philip Baba, Ansah Patrick Odum, Nonterah Engelbert A, Mensah Nathan Kumasenu, Akazili James, Beisel Ulrike
Navrongo Health Research Centre, Navrongo, Ghana.
School of Public Health, C.K Tedam University of Technology and Applied Sciences, Navrongo, Ghana.
PLOS Glob Public Health. 2025 Apr 8;5(4):e0003201. doi: 10.1371/journal.pgph.0003201. eCollection 2025.
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.
虽然随着时间的推移，临床试验不断发展和改进，在疾病的诊断、治疗和预防方面取得了重大进展，但也存在一些关键挑战，如某些临床试验的可行性，以及最重要的是临床试验实施过程中的信任问题。因此，本研究提供了科学证据，以应对与临床试验实施相关的挑战，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，于2019年6月至8月期间对参与者进行了48次深入访谈和关键信息人访谈。访谈进行了录音、转录，并在进行主题内容分析之前，使用QSR Nvivo 12软件编码成主题。结果显示，加纳民众对临床试验实施的信任度较低。参与者推荐了几种信任建立策略，以在整个临床试验周期中提高信任度。建议采取实施前策略，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。强烈推荐采取实施策略，如有效监测、解决关于血液样本采集和使用的不可信问题和误解、改进知情同意程序，以及实施后策略，如及时向临床试验社区反馈，以建立对临床试验实施的信任。信任是影响临床试验实施的一个重要因素，特别是在发展中国家。通过适当的利益相关者参与和临床试验监管机构的有效监测系统，在国家和社区层面投资于信任建设活动，是提高对临床试验实施信任度的关键策略。
