Chatio Samuel Tamti, Ganle John Kuumuori, Adongo Philip Baba, Beisel Ulrike
Department of Social Science, Navrongo Health Research Centre, Navrongo, Ghana.
School of Public Health, Colleague of Health Sciences, University of Ghana, Legon, Accra, Ghana.
PLOS Glob Public Health. 2023 Mar 14;3(3):e0001178. doi: 10.1371/journal.pgph.0001178. eCollection 2023.
Evidence exists that scientists' dehumanization and exploitation of people in the name of science led to suspicion and mistrust in clinical trials conduct. In Ghana, there are equally signs of public distrust in the conduct of biomedical research. Typical examples are the unsuccessful conduct of the Ebola vaccine trial and the initial refusal of parents to allow their children to receive the recently piloted malaria vaccine in Ghana. Therefore, this study explored participants' views on factors affecting trust in clinical trials conduct in Ghana. This was a cross-sectional exploratory study using qualitative research approach. Forty-eight in-depth interviews and Key informant interviews were conducted with stakeholders. Purposive sampling technique was used to select participants. All the interviews were recorded, transcribed and coded into themes using QSR Nvivo 12 software to aid thematic analysis. Overall, participants saw the need for the conduct of clinical trials in Ghana because clinical trial studies enable scientists to come out with effective medicines for the management of diseases. Pre-implementation factors such as inadequate stakeholder engagement, rumours and negative influence affected trust. Implementation factors such as perceived risks about clinical trials medicines, apprehensions on drawing and use of blood samples, poor informed consent administration and perceived no illness all negatively affected trust in clinical trials conduct. Trust is a fundamental factor affecting a successful conduct of clinical trials. Thus, there is need for collective efforts by all stakeholders including research institutions and clinical trial regulatory bodies to take the issue of trust in clinical trials conduct seriously.
有证据表明，科学家以科学之名对人的非人化和剥削导致了对临床试验开展的怀疑和不信任。在加纳，公众对生物医学研究开展同样存在不信任的迹象。典型例子是埃博拉疫苗试验开展失败，以及加纳家长最初拒绝让孩子接种最近试点的疟疾疫苗。因此，本研究探讨了参与者对影响加纳临床试验开展信任度因素的看法。这是一项采用定性研究方法的横断面探索性研究。对利益相关者进行了48次深入访谈和关键信息人访谈。采用目的抽样技术选择参与者。所有访谈都进行了录音、转录，并使用QSR Nvivo 12软件编码成主题，以辅助主题分析。总体而言，参与者认为在加纳开展临床试验有必要，因为临床试验研究能使科学家研发出治疗疾病的有效药物。实施前因素，如利益相关者参与不足、谣言和负面影响，影响了信任。实施因素，如对临床试验药物的感知风险、对采血和使用血样的担忧、知情同意管理不善以及感觉没有患病，都对临床试验开展的信任产生了负面影响。信任是影响临床试验成功开展的一个基本因素。因此，包括研究机构和临床试验监管机构在内的所有利益相关者需要共同努力，认真对待临床试验开展中的信任问题。
