Evidence map›Paper›PMID 40718886›Full record

ArticlePerspectives in clinical research

The landscape of Phase IV Clinical Trials in India - A comprehensive analysis of the Clinical Trial Registry-India.

Bikash Ranjan Meher, Bikram Keshari Rout, Subashri Ponnusamy, Rashmi Ranjan Mohanty, Biswa Mohan Padhy

Abstract read
In one paragraph

Article in Perspectives in clinical research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Bikash Ranjan MeherDepartment of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
Bikram Keshari RoutDepartment of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
Subashri PonnusamyDepartment of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
Rashmi Ranjan MohantyDepartment of General Medicine, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
Biswa Mohan PadhyDepartment of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Phase IV clinical studies are usually performed after a new drug obtains approval from a regulatory agency for marketing and use in the general population. There is not much information available on public platform regarding the types of contemporary Phase IV studies conducted in India. We aimed to determine the fundamental characteristics of Phase IV clinical trials using the Clinical Trials Registry-India (CTRI) registry data. Materials and Methods: A comprehensive search was undertaken for the total number of Phase IV studies registered between the inception of CTRI and May 2024. Information was analyzed based on the different characteristics of the registered study like year of registration, type of study, type of intervention, type of outcome, and type of sponsorship. Results: Two hundred and thirty-eight studies fulfilling the inclusion criteria were included in the analysis. Twenty-nine (12.2%) of those were undertaken to assess only safety outcomes, 27 (11.4%) had only efficacy outcomes whereas a large number of studies ( Conclusion: Although progress has been made in the conduction of clinical research in India, there is a need to conduct more Phase IV clinical studies and provide the details of their publication on the CTRI site to enhance credibility and transparency.

Indexed as

Clinical trial registryClinical Trials Registry-IndiaPhase IV clinical trialsPhase IV studiespostmarketing studies

Identifiers

PMID40718886
PMCPMC12288912

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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Registered trials

None linked

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.