Participant perception, still a major challenge to clinical research in developing countries—A mixed methods study

Abstract

Background With the introduction of the Clinical Trial Act in 2011, Mauritius has witnessed significant progress in the running of clinical trials. Our aim was to provide insights on the perception of clinical trials among Mauritian citizens and highlight areas of opportunities to address gaps in public perception and awareness. Population, materials and methods A mixed study was carried out which consisted of 2 phases: a qualitative, with thematic approach followed by a quantitative study with cross-sectional design. For the qualitative study, computer literate individuals were invited to fill an unstructured, online open-ended questionnaire. Conclusions derived from the latter were used to adapt a validated questionnaire which was then distributed to 400 consented participants. Results There were 23 participants who responded to the online qualitative survey, which showed poor knowledge and diverse views on clinical trials. Quantitatively up to 48% of the participants were not aware of clinical trials which included people of older age group, those from low socioeconomic status and those with low literacy level (p<0.050). Majority of respondents agreed with the value of research while a minority had poor perception related to trust in research companies and conduct of clinical trials. Respondents who had previously engaged in clinical research had better knowledge and perception compared to those who did not participate in one (Odds Ratio = 1.7). Conclusion This novel study provided a foundation of how Mauritian citizens perceive clinical trials. Public awareness and educational programs can be created to address lack of awareness, the negative perceptions and knowledge gaps of clinical trials among Mauritian citizens.

Translation and Validation of the Greek Version of a Questionnaire Measuring Patient Views on Participation in Clinical Trials

“…Respondents (28.4%) in a study carried out recently by Mowlabaccus and Jodheea-Jutton raise concerns towards trust in pharmaceutical companies [41]. It seems to be important to participants in clinical trials to be sure that the nal bene ciaries of trials are patients rather than commercial pharmaceutical companies [74].…”

“…It seems to be important to participants in clinical trials to be sure that the nal bene ciaries of trials are patients rather than commercial pharmaceutical companies [74]. Furthermore, 32.8% of the responders perceived government as an insu cient guarantor of public against unethical clinical research [41]. In the same vein was a study carried out by Burt et al [75].…”

“…However, several studies reported several facilitators or signi cant barriers to trial participation [32,33]. Among factors affecting people's willingness to participate in clinical trials the following have been cited: age and race [34,35,36,37], inconvenience to participate [38,39], economic bene t [40,41], socio-economic factors [34,42], education level [34,41,43], availability of treatment options, participants' burden, participants' health status, racial difference [44], and types of research [45].…”

“…Improving participants' health status is cited as a facilitator of clinical trial participation [41]. Ferrell et al found that patients inclined to participate "had no other treatment options if they wanted to live longer, or they wanted to help future patients with cancer.…”

“…More particularly, fears of drugrelated side effects have been cited in literature as a major barrier to participating in clinical trials [34,42,89]. In a recent study, around 47% of participants were afraid of potential side effects [41]. Catania et al found that 50% of the respondents in their study were feared of receiving unknown or little-known drugs [31].…”