Knowledge and awareness of clinical trials among trial participants in India: A multicentric questionnaire-based cross-sectional study.

Abstract

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. 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. 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. 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.