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

参与者感知仍然是发展中国家临床研究面临的主要挑战——一项混合方法研究

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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.

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