ArticleCureus2026
Phase III Trials in India: A Comprehensive Analysis of the Clinical Trials Registry-India.
Article in Cureus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPhase III clinical trials are essential for establishing the safety and efficacy of therapeutic interventions prior to regulatory approval. India has emerged as an important clinical research hub; however, long-term trends in phase III trials registered in the Clinical Trials Registry-India (CTRI) remain inadequately explored.
methodsA comprehensive analysis of phase III clinical trials registered in CTRI between 2007 and June 2025 was conducted. Trials were categorized into two periods, namely, 2007-2014 and 2015-2025, representing pre- and post-regulatory reform eras. Data regarding randomization, blinding, comparator type, intervention model, sponsorship, study site, intervention agents, geographic scope, and recruitment status were extracted and analyzed using descriptive statistics and chi-squared/Fisher's exact tests.
resultsA total of 1385 phase III clinical trials were analyzed. Randomized controlled trials significantly increased from 360 (88.7%) in 2007-2014 to 928 (94.8%) in 2015-2025 (p<0.001), while non-randomized studies declined. Active-controlled trials increased significantly (234 (57.6%) vs. 608 (62.1%); p=0.025), and parallel-group designs became more common (365 (89.9%) vs. 922 (94.2%); p=0.005). Industry-sponsored trials decreased from 374 (92.1%) to 799 (81.6%), accompanied by increased participation from educational and research institutions (p<0.001). Drug trials remained predominant, although vaccine and biologic/device-based studies increased significantly in the latter period. Recruitment status analysis demonstrated declining completed trials and increasing ongoing or "not yet recruiting" studies, likely reflecting stricter registration practices and pandemic-related disruptions.
conclusionPhase III clinical trials registered in CTRI demonstrated substantial improvements in methodological rigor, comparator selection, intervention design, sponsorship diversity, and reporting characteristics during 2015-2025 compared with 2007-2014. These favorable trends are temporally associated with the major Indian and international regulatory reforms, including the New Drugs and Clinical Trials (NDCT) Rules 2019, International Council for Harmonisation's Guideline for Good Clinical Practice (ICH-GCP) updates, and strengthened ethical oversight. Nevertheless, persistent challenges related to trial completion and reporting transparency warrant continued regulatory strengthening.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.