Article type
Abstract
Background: Patient engagement and involvement are pivotal for the success of clinical trials. Providing the public with access to information about ongoing trials is essential to facilitate this process. Clinical trial registries serve as comprehensive databases of ongoing trials, offering patients a vital source of this information. However, the accessibility and user-friendliness of the Indian Clinical Trial Registry for the lay community is not known.
Objectives:
1. Assess the accessibility of the existing Clinical Trial Registry – India (CTRI) for the public. Identify features that can enhance accessibility by comparing it with other global registries.
2. Gather insights from patients and patient advocates in India regarding their experiences of accessing trial information.
Methodology: We conducted a comprehensive assessment of various global clinical trial registries, including CTRI, ClinicalTrials.gov, Singapore Clinical Trials Register, European Union Clinical Trials Register, and ISRCTN Registry. This comparative analysis allowed us to identify user access features that could benefit patients/caregivers and assess the patient-friendliness of the CTRI website. Additionally, we conducted a focused group discussion with patients and patient advocates (n=5) to gain insights into their information-seeking behaviours regarding trials and their experiences with using CTRI.
Results: The study identifies significant shortcomings regarding the ease of locating, timeliness, and clarity of information concerning trials in CTRI. Based on these findings, we have formulated the following recommendations aimed at improving its user-friendliness and accessibility for patients:
a) Improving search visibility, search functionality, and presenting crucial information in layperson-friendly language, alongside offering multilingual support.
b) Ensuring the provision of up-to-date information through prominently highlighting study status updates and recruitment statuses.
c) Facilitating comprehension through the provision of comprehensive glossaries, help resources, integration of patient and advocacy organization data, and offering patient-centric education and resources.
Conclusions: While one of CTRI's objectives is to offer transparent information about ongoing trials in the public domain, our study revealed significant shortcomings in its ability to provide comprehensive access to patients. Adopting the recommendations outlined in this study may empower patients and caregivers with crucial trial information, promoting a more transparent and patient-friendly clinical trial landscape in India and aiding in the evidence-generation process.
Objectives:
1. Assess the accessibility of the existing Clinical Trial Registry – India (CTRI) for the public. Identify features that can enhance accessibility by comparing it with other global registries.
2. Gather insights from patients and patient advocates in India regarding their experiences of accessing trial information.
Methodology: We conducted a comprehensive assessment of various global clinical trial registries, including CTRI, ClinicalTrials.gov, Singapore Clinical Trials Register, European Union Clinical Trials Register, and ISRCTN Registry. This comparative analysis allowed us to identify user access features that could benefit patients/caregivers and assess the patient-friendliness of the CTRI website. Additionally, we conducted a focused group discussion with patients and patient advocates (n=5) to gain insights into their information-seeking behaviours regarding trials and their experiences with using CTRI.
Results: The study identifies significant shortcomings regarding the ease of locating, timeliness, and clarity of information concerning trials in CTRI. Based on these findings, we have formulated the following recommendations aimed at improving its user-friendliness and accessibility for patients:
a) Improving search visibility, search functionality, and presenting crucial information in layperson-friendly language, alongside offering multilingual support.
b) Ensuring the provision of up-to-date information through prominently highlighting study status updates and recruitment statuses.
c) Facilitating comprehension through the provision of comprehensive glossaries, help resources, integration of patient and advocacy organization data, and offering patient-centric education and resources.
Conclusions: While one of CTRI's objectives is to offer transparent information about ongoing trials in the public domain, our study revealed significant shortcomings in its ability to provide comprehensive access to patients. Adopting the recommendations outlined in this study may empower patients and caregivers with crucial trial information, promoting a more transparent and patient-friendly clinical trial landscape in India and aiding in the evidence-generation process.