Bridging the Gap: How Digital Twins Can Address Clinical Trial Delays in India

Abstract

Clinical trials in India are often delayed due to regulatory bottlenecks, site-level inefficiencies, and patient recruitment challenges. Digital twin technology—virtual replicas of real-world processes—offers potential to streamline trials through simulation, optimisation, and predictive modelling. However, research on its application in India remains scarce. This study aimed to explore whether digital twins could help reduce trial delays and to assess the perceptions and readiness of clinical research professionals in India. Methods A mixed methods strategy was adopted, combining primary and secondary research. Surveys were conducted with 149 clinical research professionals to gather quantitative insights, while in-depth interviews with 8 experts provided qualitative perspectives. Quantitative data were analysed using descriptive statistics, and qualitative data were examined through thematic analysis to identify themes and sub-themes aligned with the research objectives. Results Findings showed that delays were primarily driven by slow regulatory approvals, ethics committee backlogs, site-level inefficiencies, and recruitment difficulties. Awareness of digital twins was limited, but professionals recognised their potential to improve protocol design, patient recruitment, and trial predictability. Key barriers included high costs, infrastructure limitations, regulatory uncertainty, and lack of expertise. Despite these obstacles, respondents expressed cautious optimism about adoption, citing ongoing digitalisation trends, workforce training, and evolving regulatory frameworks as enablers. Conclusion The study concludes that while India’s clinical trials continue to face systemic delays, digital twin technology represents a promising avenue for improvement. The research fills a regional gap in the literature, offering both conceptual insights and practical recommendations for future adoption. Broader stakeholder engagement and pilot projects will be crucial to validate its effectiveness in real-world settings