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June 13, 2026CureusOpen Access

Phase III Trials in India: A Comprehensive Analysis of the Clinical Trials Registry-India

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Authors

ASAjaya SahooBMBikash Ranjan MeherMJMonalisa Jena

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Overview

Comprehensive analysis highlights regulatory impact on phase III trial quality in India from 2007 to 2025.

Key Points

  • To analyze trends in phase III clinical trials registered in the Clinical Trials Registry-India (CTRI) from 2007 to 2025.
  • Conducted a comprehensive analysis of 1385 phase III trials registered in CTRI from 2007 to June 2025.
  • Categorized trials into two periods: 2007-2014 and 2015-2025 to assess changes pre- and post-regulatory reforms.
  • Used descriptive statistics and chi-squared/Fisher's exact tests for data analysis.
  • Randomized controlled trials increased significantly from 88.7% in 2007-2014 to 94.8% in 2015-2025 (p<0.001).
  • Active-controlled trials rose from 57.6% to 62.1% during the same periods (p=0.025).
  • Industry-sponsored trials decreased from 92.1% to 81.6%, with increased involvement from educational and research institutions (p<0.001).

Cite This Study

Sahoo et al. (2026) studied this question.

synapsesocial.com/papers/6a2cf4aefaef96ed7f056d68https://doi.org/10.7759/cureus.110645
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