Factors Affecting Trust in Clinical Trials Conduct: Views of Stakeholders from a Qualitative Study in Ghana

"The increasing signs of distrust in public institutions and biomedical science...clearly suggest a need for examining factors affecting trust in clinical research especially in low-income settings."

In Africa, there have been reported cases of public distrust in biomedical research, which led, for instance, to the boycott of the 2003 polio vaccination campaigns in Northern Nigeria. More recent examples in Ghana include the unsuccessful conduct of the Ebola vaccine trial and the initial refusal of parents to allow their children to receive a piloted malaria vaccine. This study explored participants' views on factors affecting trust in clinical trials conduct in Ghana.

Kasperson's social amplification of risks framework (KSARF) has been adopted and used in the design of this study. This framework highlights factors that influence risk perception and how risk events are interpreted and communicated by social actors such as institutional stakeholders and traditional and social media in ways that may increase or decrease public reactions to the risk event. The KSARF was deemed relevant to this work because it provides the framework to analyse individual-, community-, and socio-cultural-level actors pertaining to trust in clinical trials and how messages about trials are communicated.

As part of this cross-sectional exploratory study, 48 in-depth interviews and key informant interviews were conducted between June and August 2019. The study participants included: community opinion leaders; clinical trial scientists and monitors; and community members (i.e., people who: have never taken part in clinical trials, who qualified but have not shown interest in participating in trials, who were recruited into trials and later dropped out, and who have taken part in at least 3 trials).

Overall, participants saw the need for the conduct of clinical trials in Ghana because clinical trials enable scientists to create effective medicines for the management of diseases. Nonetheless, some participants perceived that it was risky for new medicines to be tested on human beings through the conduct of clinical trials. Pre-implementation factors (i.e., before the conduct of trial studies) affecting trust included:

• Inadequate community and stakeholder engagement to create awareness on clinical trials: Lack of stakeholders' engagement and education led to the failed Ebola vaccine trial in Ghana, according to participants. Clinical trial monitors and regulators also reported that lack of information could lead to misconceptions about clinical trials conduct, such as the notion that human beings are used as guinea pigs.
• Rumours and negative influence: Clinical trial scientists and regulators reported that misinformation given to community members about perceived risks associated with the conduct of clinical trials negatively affected trust. They gave examples of how community members were negatively influenced through audios, videos, and WhatsApp messages that were circulated on social media platforms and internet advising people not to take part in the planned Ebola vaccine trial and the piloted malarial vaccine in Ghana. Some community members also recounted instances where negative influence from individuals through audio recordings had influenced their trust and decision to drop out of the piloted malaria vaccine exercise in Ghana.

Implementation factors (i.e., during the conduct of trial studies) that negatively affected trust in clinical trials conduct included:

• Perceived risks and uncertainties: Community members explained that experience of side effects from routine vaccinations people had received in the past contributed to low trust in clinical trials conduct. They gave examples on how people were scared of the piloted malaria vaccine, which made them refuse to allow their children to participate in the exercise. It was reported by one opinion leader that people had the perception that using clinical trial drugs could lead to impotency and also shortened an individual life span.
• Apprehension about drawing and use of blood samples: According to participants, the inability of clinical trial scientists to explain to community members on reasons for drawing and use of blood samples led to doubts on what exactly these samples were used for. One clinical trial scientist said, "The reason is that blood is very significant in our local communities because some people believe that life is in the blood and so, when you take somebody's blood you have actually come in contact with the person's spirit. There is also rumour that blood drawn from study participants is sold by researchers."
• Poor informed consent administration: One of the clinical trial scientists emphatically stated that serious attention was not given to informed consent by clinical trial investigators in terms of how well data collectors were trained to administer informed consent to participants prior to their recruitment into these studies.
• No perception of illness: One community member said, "I am not sick and yet researchers want to give me medicine! I do not really understand..."

Thus, this study highlighted the "need for collective efforts by all stakeholders particularly academic institutions, research institutions, Ghana health services and civil society organizations as well as clinical trial regulatory bodies to take the issue of trust in the conduct of clinical trials seriously. In addition, investment in national, regional and community level trust-building activities through appropriate community and stakeholder engagement strategies is highly recommended to address the issue of mistrust resulting from misconceptions people have in clinical trials conduct."