Decentralised clinical trials in India: Stakeholders' perspectives
1Department of Clinical Research, Texila American University, Guyana, South America.
The Indian Journal of Medical Research
|April 4, 2026
Summary
Decentralised clinical trials, particularly hybrid models, are gaining traction in India, improving patient convenience and diversity. However, limited digital literacy and regulatory uncertainty pose challenges to wider adoption.
Area of Science:
- Clinical Research
- Digital Health
- Health Services Research
Background:
- Decentralised clinical trials (DCTs) utilize digital technologies to improve accessibility and efficiency in research.
- This study focuses on the adoption of DCTs among Indian clinical research professionals.
Purpose of the Study:
- To assess the adoption, perceived benefits, and challenges of decentralised clinical trials in India.
- To understand patient satisfaction and future expectations regarding DCTs.
Main Methods:
- Sub-analysis of a global cross-sectional survey (n=288) involving 47 Indian site professionals.
- Data collected on roles, trial types, therapeutic areas, benefits, challenges, and patient satisfaction.
- Descriptive statistics, weighted averages, and mean rank analysis were employed.
Main Results:
- Hybrid trials (71%) were more common than fully decentralized trials (29%).
- Home health visits and remote monitoring were frequently adopted components, especially in oncology and cardiovascular trials.
- Key benefits included improved patient convenience (3.8) and diversity (3.5); challenges included limited digital literacy (2.3) and regulatory uncertainty (6.1).
- Patient satisfaction averaged 4.0, with 83% expecting continued growth in hybrid trial adoption.
Conclusions:
- Hybrid DCTs show potential for enhancing inclusivity and efficiency in India, particularly for non-communicable diseases.
- Gaps in digital literacy and regulatory clarity impede the scale-up of DCTs.
- Strategic investments in training, infrastructure, and regulatory frameworks are essential for maximizing DCT potential.
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