Enhancing digital evolution in Indian clinical trials: bridging technological, participant, and regulatory gaps

The rapid evolution of digital technologies has transformed clinical trials, offering improved efficiency and broader patient participation. However, in India, the transition to digital clinical trials presents multiple challenges, including regulatory uncertainties, ethical concerns, infrastructural limitations, and patient participation barriers. Ethics committees face a lack of trained personnel, unfamiliarity with digital guidelines, and delays in approvals, while regulatory bodies struggle with evolving frameworks and compliance issues. Additionally, sponsors and trial sites encounter difficulties in data security, patient engagement, and technology integration. Addressing these challenges requires a collaborative effort involving regulatory reforms, ethical training, enhanced digital infrastructure, and the implementation of standardized processes. Nevertheless, recent initiatives highlight successful digital adoption, supported by frameworks like the New Drugs and Clinical Trials Rules 2019 and Digital Personal Data Protection Act 2023. This review explores the challenges and proposes strategic solutions to optimize digital clinical trials in India. By leveraging India's digital health momentum and fostering multisectoral collaboration, the clinical research ecosystem can become more agile, equitable, and globally aligned.