Use of digital healthcare technology in clinical research in the Indian setting: Opportunities and challenges

Abstract Digital healthcare technologies (DHTs) are increasingly transforming the conduct of clinical trials (CTs) by enabling patient-centric, efficient, data-driven research models. Traditional clinical research is often constrained by challenges related to participant recruitment and retention, frequent site visits, high operational costs, and limitations in real-time data collection. The COVID-19 pandemic accelerated the adoption of digital tools, giving rise to digital and decentralized CTs that leverage electronic data capture, electronic informed consent, mobile health applications, wearable devices, and remote patient monitoring. Globally, the use of DHTs in clinical research has grown rapidly, and India has emerged as an attractive destination due to its diverse disease burden, expanding digital infrastructure, and widespread smartphone penetration. This review examines the opportunities and challenges associated with the use of DHTs in clinical research within the Indian context. DHTs offer several advantages, including targeted and accelerated recruitment, improved participant engagement and retention, reduced travel burden, continuous and objective real-world data collection, and improved operational efficiency. Despite these benefits, multiple barriers hinder optimal adoption in India. Key challenges include data security and privacy concerns, regulatory uncertainty, adoption and acceptance of devices, variable digital literacy, infrastructure and network limitations, and the need for extensive training among stakeholders. In conclusion, DHTs hold significant promise for enhancing the quality, efficiency, and inclusiveness of clinical research in India. Addressing regulatory, infrastructural, ethical, and capacity-building challenges through coordinated stakeholder efforts will be essential to realize their full potential and shape the future of CTs in the Indian setting.