Letter on: “An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India”

Maulik, Mohua; Gupta, Jyotsna; Juneja, Atul; Adhikari, Tulsi; Sharma, Saurabh; Panchal, Yashmin; Yadav, Neha; Rao, M. Vishnu Vardhana

doi:10.1186/s13063-019-4010-3

Cited by 2 publications

(3 citation statements)

References 3 publications

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“…Apart from India and USA, there are many countries which maintain their own clinical trial registries including European Union, Japan, China, Korea, Australia, Brazil, Germany, Thailand, and Sri Lanka. [ 11 ] The present study was planned to analyze and evaluate the compliance of Indian and global sponsors with the Clinical Trials Registry-India (CTRI) in terms of reporting of clinical trial results and to compare the proportion of reporting of results with the US FDA Clinical Trial Registry called Clinical Trials. gov website.…”

Section: Discussionmentioning

confidence: 99%

“…[ 10 ] However, most of these deficiencies were addressed in the Letter to the Editor to the same journal by Maulik et al . [ 11 ] In this audit, we aimed to evaluate only the clinical trial results field of CTRI and looked for compliance of Indian and global sponsors with clinical trial site in India in terms of reporting of clinical trial results. We also wished to compare the proportion of studies that reported clinical trial results at CTRI with that of published data available at the US FDA Clinical Trial Registry called as Clinical Trials.gov maintained by the U. S. National Library of Medicine.…”

Section: Introductionmentioning

confidence: 99%

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Public disclosure of clinical trial results at Clinical Trial Registry of India- Need for transparency in research!

Munshi

Pilliwar

Maurya

2022

Perspectives in Clinical Research

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Introduction: Since June 15, 2009, clinical trial registration in the Clinical Trial Registry-India (CTRI) has been made mandatory by the Drugs Controller General of India to improve transparency, accountability, conform to accepted ethical standards and reporting of all relevant results of registered trials. In this study, we planned to evaluate the compliance of Indian and global sponsors with clinical trials conducted in India in terms of reporting of clinical trial results at the CTRI. Methods: We included trials registered in the CTRI between January 2018 and January 2020. The CTRI and ClinicalTrials.gov registry was thoroughly searched for all completed interventional studies. A year-wise comparative analysis was performed to evaluate the number of clinical trials reporting results in both the registry. Results: The reporting of completed interventional clinical trial results was 25/112 (22.32%) in year 2018, y, 8/105 (7.6%) in year 2019 and 17/140 (12.14%) in year 2020. There was significantly less reporting of results of Pharmaceutical company sponsored Interventional Studies-Indian at CTRI when compared with ClinicalTrials.gov registry for the year 2019 (odds ratio [OR]-0.17 (95% confidence interval [CI]: 0.08–0.36) and P < 0.0001) and year 2020 (OR-0.45 [95% CI: 0.24–0.82] and P < 0.01). The difference in results reported at CTRI was significantly low for Pharmaceutical company sponsored Interventional Studies-Global only for year 2019 (OR-0.09 [95% CI: 0.005–1.45] and P = 0.04) compared with ClinicalTrials.gov. Conclusion: There is a need to develop the culture of reporting clinical trial results in CTRI to strengthen the transparency in the research for overall benefit of public, health care professionals, and research community.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Public disclosure of clinical trial results at Clinical Trial Registry of India- Need for transparency in research!

Munshi

Pilliwar

Maurya

2022

Perspectives in Clinical Research

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“…We first consider the listing of more ECs than sites. The CTRI staff have explained one possible cause of this [29], as follows. If new sites are to be added to the CTRI record, the trialist first uploads the ethics approval documents.…”

Section: Plos Global Public Healthmentioning

confidence: 99%

An analysis of deficiencies in the ethics committee data of certain interventional trials registered with the Clinical Trials Registry–India

Chakraborty

Shreya²,

Mendiratta³

et al. 2022

PLOS Glob Public Health

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There is widespread agreement that clinical trials should be registered in a public registry, preferably before the trial commences. It is also important that details of each trial in the public record are complete and accurate. In this study, we examined the trial sites and ethics committee (EC) data for 1359 recent Phase 2 or Phase 3 interventional trials registered with Clinical Trials Registry–India (CTRI), to identify categories of problems that prevent the clear identification of which EC approved a given site. We created an SQLite database that hosted the relevant CTRI records, and queried this database, as needed. We identified two broad categories of problems: those pertaining to the understanding of an individual trial and those to adopting a data analytics approach for a large number of trials. Overall, about 30 problems were identified, such as an EC not being listed; an uninformative name of the EC that precluded its clear identification; ambiguity in which EC supervised a particular site; repetition of a site or an EC; the use of a given acronym for different organizations; site name not clearly listed, etc. The large number of problems with the data in the EC or site field creates a challenge to link particular sites with particular ECs, especially if a programme is used to find the matches. We make a few suggestions on how the situation could be improved. Most importantly, list the EC registration number for each EC, merge the site and EC tables so that it is clear which EC is linked to which site; and implement logic rules that would prevent a trial from being registered unless certain conditions were met. This will raise user confidence in CTRI EC data, and enable data based public policy and inferences. This will also contribute to increased transparency, and trust, in clinical trials, and their oversight, in India.

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Letter on: “An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India”

Cited by 2 publications

References 3 publications

Public disclosure of clinical trial results at Clinical Trial Registry of India- Need for transparency in research!

Public disclosure of clinical trial results at Clinical Trial Registry of India- Need for transparency in research!

An analysis of deficiencies in the ethics committee data of certain interventional trials registered with the Clinical Trials Registry–India

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