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

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.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.This was a cross-sectional and questionnaire-based study that included five tertiary eye care hospitals that are part of the Indian Ophthalmology Clinical Trial Network (IOCTN). The IOCTN was sponsored by the Biotechnology Research Assistance Council (BIRAC) under the National Biopharma Mission (NBM) to accelerate the early development of biopharmaceuticals and promote innovation in India (i3), empowering biotech entrepreneurs and accelerating inclusive innovations. The IOCTN represents networks of clinicians and researchers conducting quality CTs and maintaining clinical registries in India, and the activities of the IOCTN represent the development, implementation, and support of a national framework for conducting efficient and effective CTs and quality clinical registries. The IOCTN also has the scope for promoting personalized treatment in ophthalmology to enhance patient compliance with the approved drugs/biologicals. The study was initiated after obtaining approval from the institutional ethics committee. All the participants had signed an informed consent form (ICF) before their recruitment in the study. The study included participants aged more than 18 years who were involved in CTs in the past or were currently enrolled in any CT among the IOCTN. Those unwilling to participate were excluded from the study. A close-ended questionnaire was designed and framed to analyze and oversee the knowledge and perception regarding CTs in India. The 24 questions used in the study were designed from a previously validated questionnaire[11] and reported results from publications.[5,12] The hard-copy questionnaire was translated into local languages such as Hindi, Marathi, Malayalam, and Assamese by certified translators. 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.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.This was a cross-sectional and questionnaire-based study that included five tertiary eye care hospitals that are part of the Indian Ophthalmology Clinical Trial Network (IOCTN). The IOCTN was sponsored by the Biotechnology Research Assistance Council (BIRAC) under the National Biopharma Mission (NBM) to accelerate the early development of biopharmaceuticals and promote innovation in India (i3), empowering biotech entrepreneurs and accelerating inclusive innovations. The IOCTN represents networks of clinicians and researchers conducting quality CTs and maintaining clinical registries in India, and the activities of the IOCTN represent the development, implementation, and support of a national framework for conducting efficient and effective CTs and quality clinical registries. The IOCTN also has the scope for promoting personalized treatment in ophthalmology to enhance patient compliance with the approved drugs/biologicals. The study was initiated after obtaining approval from the institutional ethics committee. All the participants had signed an informed consent form (ICF) before their recruitment in the study. The study included participants aged more than 18 years who were involved in CTs in the past or were currently enrolled in any CT among the IOCTN. Those unwilling to participate were excluded from the study. A close-ended questionnaire was designed and framed to analyze and oversee the knowledge and perception regarding CTs in India. The 24 questions used in the study were designed from a previously validated questionnaire[11] and reported results from publications.[5,12] The hard-copy questionnaire was translated into local languages such as Hindi, Marathi, Malayalam, and Assamese by certified translators. 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.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.This was a cross-sectional and questionnaire-based study that included five tertiary eye care hospitals that are part of the Indian Ophthalmology Clinical Trial Network (IOCTN). The IOCTN was sponsored by the Biotechnology Research Assistance Council (BIRAC) under the National Biopharma Mission (NBM) to accelerate the early development of biopharmaceuticals and promote innovation in India (i3), empowering biotech entrepreneurs and accelerating inclusive innovations. The IOCTN represents networks of clinicians and researchers conducting quality CTs and maintaining clinical registries in India, and the activities of the IOCTN represent the development, implementation, and support of a national framework for conducting efficient and effective CTs and quality clinical registries. The IOCTN also has the scope for promoting personalized treatment in ophthalmology to enhance patient compliance with the approved drugs/biologicals. The study was initiated after obtaining approval from the institutional ethics committee. All the participants had signed an informed consent form (ICF) before their recruitment in the study. The study included participants aged more than 18 years who were involved in CTs in the past or were currently enrolled in any CT among the IOCTN. Those unwilling to participate were excluded from the study. A close-ended questionnaire was designed and framed to analyze and oversee the knowledge and perception regarding CTs in India. The 24 questions used in the study were designed from a previously validated questionnaire[11] and reported results from publications.[5,12] The hard-copy questionnaire was translated into local languages such as Hindi, Marathi, Malayalam, and Assamese by certified translators. 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.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.This was a cross-sectional and questionnaire-based study that included five tertiary eye care hospitals that are part of the Indian Ophthalmology Clinical Trial Network (IOCTN). The IOCTN was sponsored by the Biotechnology Research Assistance Council (BIRAC) under the National Biopharma Mission (NBM) to accelerate the early development of biopharmaceuticals and promote innovation in India (i3), empowering biotech entrepreneurs and accelerating inclusive innovations. The IOCTN represents networks of clinicians and researchers conducting quality CTs and maintaining clinical registries in India, and the activities of the IOCTN represent the development, implementation, and support of a national framework for conducting efficient and effective CTs and quality clinical registries. The IOCTN also has the scope for promoting personalized treatment in ophthalmology to enhance patient compliance with the approved drugs/biologicals. The study was initiated after obtaining approval from the institutional ethics committee. All the participants had signed an informed consent form (ICF) before their recruitment in the study. The study included participants aged more than 18 years who were involved in CTs in the past or were currently enrolled in any CT among the IOCTN. Those unwilling to participate were excluded from the study. A close-ended questionnaire was designed and framed to analyze and oversee the knowledge and perception regarding CTs in India. The 24 questions used in the study were designed from a previously validated questionnaire[11] and reported results from publications.[5,12] The hard-copy questionnaire was translated into local languages such as Hindi, Marathi, Malayalam, and Assamese by certified translators. 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.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.This was a cross-sectional and questionnaire-based study that included five tertiary eye care hospitals that are part of the Indian Ophthalmology Clinical Trial Network (IOCTN). The IOCTN was sponsored by the Biotechnology Research Assistance Council (BIRAC) under the National Biopharma Mission (NBM) to accelerate the early development of biopharmaceuticals and promote innovation in India (i3), empowering biotech entrepreneurs and accelerating inclusive innovations. The IOCTN represents networks of clinicians and researchers conducting quality CTs and maintaining clinical registries in India, and the activities of the IOCTN represent the development, implementation, and support of a national framework for conducting efficient and effective CTs and quality clinical registries. The IOCTN also has the scope for promoting personalized treatment in ophthalmology to enhance patient compliance with the approved drugs/biologicals. The study was initiated after obtaining approval from the institutional ethics committee. All the participants had signed an informed consent form (ICF) before their recruitment in the study. The study included participants aged more than 18 years who were involved in CTs in the past or were currently enrolled in any CT among the IOCTN. Those unwilling to participate were excluded from the study. A close-ended questionnaire was designed and framed to analyze and oversee the knowledge and perception regarding CTs in India. The 24 questions used in the study were designed from a previously validated questionnaire[11] and reported results from publications.[5,12] The hard-copy questionnaire was translated into local languages such as Hindi, Marathi, Malayalam, and Assamese by certified translators.