Phase III Clinical Trials in India Show Major Gains in Quality and Design Over Two Decades: New Review
India: A new analysis of phase III clinical trials registered in the Clinical Trials Registry-India (CTRI) suggests that the quality, design, and reporting of late-stage clinical research in India have improved substantially over the past decade.
Researchers found greater use of randomized study designs, more diverse sponsorship, and better trial methodologies between 2015 and 2025 compared with the 2007-2014 period. However, they also noted ongoing challenges related to trial completion and transparency in reporting results.
The findings, published in Cureus, are based on a study led by Ajaya Sahoo from the Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.
Phase III clinical trials play a critical role in confirming the safety and effectiveness of new therapies before they receive regulatory approval. Although India has become a major destination for clinical research, long-term trends in the design and conduct of these trials have not been comprehensively evaluated. To address this gap, the researchers analyzed all phase III trials registered in CTRI from 2007 through June 2025.
The investigators reviewed 1,385 phase III clinical trials and compared two time periods: 2007-2014, representing the years before major regulatory reforms, and 2015-2025, reflecting the period after implementation of updated national and international clinical research guidelines. The analysis assessed trial methodology, sponsorship, intervention type, recruitment status, study design, comparator selection, and reporting characteristics.
Key findings:
- A total of 1,385 phase III clinical trials registered in CTRI between 2007 and June 2025 were analyzed.
- The proportion of randomized controlled trials increased significantly from 88.7% during 2007-2014 to 94.8% in 2015-2025, while non-randomized studies declined.
- Active-controlled trials became more common, indicating greater use of established therapies as comparators instead of placebo alone.
- Parallel-group study designs were increasingly adopted during the later period, reflecting improved methodological practices.
- Although industry remained the leading sponsor, its share declined, while participation from academic and research institutions increased significantly.
- Drug trials continued to dominate, but the number of vaccine, biologic, and medical device studies rose during 2015-2025.
- The proportion of completed trials decreased, whereas ongoing and "not yet recruiting" studies increased, possibly reflecting stricter registration requirements and disruptions related to the COVID-19 pandemic.
The researchers attributed these improvements to major national and international regulatory reforms, including the NDCT Rules 2019, updated ICH-GCP guidelines, revised ICMR ethical guidance, and stronger clinical trial oversight, noting that India's progress aligns with global trends.
They added that although the study offers a comprehensive overview of phase III clinical trials registered in CTRI over nearly two decades, it is limited by its reliance on registry data and does not assess trial quality, protocol adherence, or completeness of reported results.
The authors concluded that despite significant advances, improving trial completion and reporting transparency remains a priority. They recommended mandatory and timely disclosure of trial results, enhanced ethics committee oversight, and automated systems to monitor compliance with reporting requirements.
Reference:
Sahoo A, Meher B R, Jena M, et al. (June 11, 2026) Phase III Trials in India: A Comprehensive Analysis of the Clinical Trials Registry-India. Cureus 18(6): e110645. DOI 10.7759/cureus.110645
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