Publication:

Digital transformation of clinical research: facilitating decentralized clinical trials in India

The decentralized clinical trials make clinical research accessible by using digital tools such as e-consent, telehealth, and remote monitoring. Decentralized clinical trials in India have the potential to reduce participant burden and increase trial participation. However, the nation's disparate healthcare system, digital divide, and changing regulatory environment make broad adoption difficult. The current status of decentralized clinical trials in India is examined in this review, including significant operational, regulatory gaps, and potential implementation strategies. The aim is to offer information which will help in scaling decentralized clinical trials in India. This review compiles findings from journals, regulatory guidelines, white papers, blogs and case studies from Indian decentralized clinical trial platforms. It focuses on trends, logistical challenges, regulatory readiness in decentralized clinical trials implementation in the Indian context. To support key details tables and figures are used. India's pilot decentralized clinical trials demonstrate increased cost-effectiveness and reach, particularly when it comes to extending access outside of cities. However, region-specific infrastructure deficiencies, untrained staff for decentralization operations, and absence of e-consent provisions in New Drugs and Clinical Trial Rules 2019, restricts scalability. The 2024 draft guidance of United States’s Food and Drug Administration provides framework for decentralized clinical trials which can be implemented in India. In order to ensure ethical, and successful implementation of decentralized clinical trials for India's diverse healthcare system investment in digital health infrastructure, regulatory revisions, and site personnel training for decentralized clinical trial operations is necessary.