RESUMO
PURPOSE: The knowledge and attitude of participants toward clinical trials (CTs) are a key determinant in successful recruitment and retention. This study aimed to evaluate knowledge and awareness-attitude among the recruited CT participants about CTs. METHODS: This was a cross-sectional face-to-face survey comprising CT participants involved in the past or currently a part of a CT during this study within the Indian Ophthalmology Clinical Trial Network (IOCTN). A previously validated questionnaire was used, and data regarding demographics, knowledge, and awareness-attitude about CTs were collected. The total awareness-attitude score was used to determine the knowledge and awareness of the participants. RESULTS: A total of 121 subjects had participated in the study who were part of ongoing trials, of which only five participants had prior experience of CTs. The majority (90%) had knowledge about CTs, whereas only 7% had confirmed signing consent forms. The total awareness-attitude score significantly varied across locations (27% for the southern zone, 53% for the central zone, and 52% for the western zone), and this was negatively associated with education. The most negative attitude (38.6%) was observed regarding adequate information sharing among participants, whereas non-disruption of their routine family life (60.7%) and financial stability (67.6%) were the top most positive attitudes revealed during their participation. The participants' pre- and post-participation attitude toward CTs revealed a positive attitude. CONCLUSION: The factors influencing a participant's knowledge and attitudes toward CTs were revealed in the study. Furthermore, the need for awareness regarding benefits of CTs to the public, participant's rights, and their voluntary power were the major highlights.
Assuntos
Conhecimentos, Atitudes e Prática em Saúde , Humanos , Estudos Transversais , Inquéritos e Questionários , Índia/epidemiologiaRESUMO
Purpose: Advances in patient treatment depend heavily on clinical trials (CTs). Patient volunteers for CT are tougher to recruit and retain. In order to administer CTs effectively, it is necessary to comprehend how the public views and perceives participating in them. The study assessed the perception and attitudes of patients and bystanders toward CTs in India. Methods: This was a multi-centric, cross-sectional study among patients and bystanders using a questionnaire that consisted of socio-demographic characteristics and questions on knowledge and attitude toward participation in CTs. The minimum sample size estimated for the survey was 750. Results: A total of 1260 respondents (patients and bystanders) had participated in the survey. 42% of total respondents were aware about CTs. Unawareness regarding (i) voluntary power of an individual to participate in a CT (only 47%), (ii) entitled benefits of free treatment and medical insurance during enrolment in a CT (only 47%), and (iii) only 16% of the respondents knew involvement of human subjects in CT were the major highlights among those who had prior knowledge about CTs. Education was the most pervasive factor in shaping positive perception among the respondents. Occupation was another ubiquitous factor in shaping their perception regarding CTs. Conclusion: The majority of respondents were not aware of CTs. The major concerns observed were time consumption and harmful nature of CTs that influenced their unwillingness to participate in CTs. Initiatives such as awareness campaigns and survey assessments that would result in scientifically effective health service policies would be strategic methods to enhance CT participation.
