{"title":"The landscape of Phase IV Clinical Trials in India - A comprehensive analysis of the Clinical Trial Registry-India.","authors":"Bikash Ranjan Meher, Bikram Keshari Rout, Subashri Ponnusamy, Rashmi Ranjan Mohanty, Biswa Mohan Padhy","doi":"10.4103/picr.picr_150_24","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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 (<i>n</i> = 182, 76.4%) were conducted to assess both safety as well as efficacy parameters. Almost 98% of the studies did not provide details of publication on the CTRI platform.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 3","pages":"138-142"},"PeriodicalIF":0.0000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288912/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Perspectives in Clinical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/picr.picr_150_24","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/5/28 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
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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 (n = 182, 76.4%) were conducted to assess both safety as well as efficacy parameters. Almost 98% of the studies did not provide details of publication on the CTRI platform.
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.
期刊介绍：
This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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