Publication rate and characteristics of cancer clinical trials in India

Thomas, Vinay Mathew; John, Vineeth Mathew; Alexander, Swetha Ann; Roy, Arya Mariam; Mathew, Aju

doi:10.1016/j.jcpo.2020.100248

Cited by 5 publications

(5 citation statements)

References 20 publications

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“…Thomas et al, in their study on oncology trials registered with the CTRI in India had found that randomized trials were more likely to be published compared to nonrandomized ones (p = .007). 25 Furthermore,14.4% of the randomized trials were quasirandomized. The proportion of randomized trials that were blinded and got published was slightly higher than the proportion that was not blinded and were unpublished (58.9% vs. 56.7, p = .146).…”

Section: Discussionmentioning

confidence: 99%

“…In the present study, a higher percentage of randomized trials got published, and the majority, without randomization were not published (54.3% vs. 53.8%, p = .023). Thomas et al, in their study on oncology trials registered with the CTRI in India had found that randomized trials were more likely to be published compared to non‐randomized ones ( p = .007) 25 …”

Section: Discussionmentioning

confidence: 99%

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Publication of neurology clinical trials registered with clinical trial registry of India: A cross‐sectional study

Mishra

Agarwal

Nilima

et al. 2022

Acta Neuro Scandinavica

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Unbiased and full disclosure of trial results is vital to evidence-based medicine. Non-publication and selective publication leads to publication bias and unrealistic risk-benefit ratio. In the present study, we aim to determine the publication rate of clinical trials related to neurology registered with the Clinical Trial Registry of India (CTRI), compare the characteristics of published and unpublished trials, and evaluate the adherence of investigators to ethics-approved criteria and outcomes. Materials and Methods: A cross-sectional search using the keyword "neurology" was carried out in CTRI registry. Two independent investigators searched Pubmed, Medline, Scopus, and Google Scholar for published manuscripts. The final literature search occurred in November 2021. Results: Out of 325 trials, 102 trials were published (31.4%). Ninety-one trials were beyond 3 years of expected time of trial completion and were still unpublished.Randomized trials had a slightly higher publication rate than non-randomized ones (56% vs. 46%, p = .223); however the difference was not statistically significant.Majority of trials sponsored by pharmaceutical companies were not published, while majority of those sponsored by non-pharmaceutical institutions were published (34.5% vs. 69.3%, p < .001). Feedback to CTRI about trial status was particularly poor (31.5% -informed vs. 68.5% -not informed, p < .001). 52 (50.9%) and 65 (63.7%) of the 102 published trials had changed the registered inclusion and exclusion criteria, respectively, in the CTRI registry compared to those in the published manuscript. In 29 (28.3%) of the 102 trials, the primary outcome did not match with that registered in the CTRI and in 73 (57.8%) trials, the secondary outcomes did not match. Conclusion:A large proportion of neurology registered trials are still unpublished, with a majority of pharmaceutical company-sponsored trials not being published.There is scope for improving the provisions in CTRI for enlisting trial results, that may prevent publication bias and also ensure the investigators adhere to the pre-specified ethics approved trial procedures and outcomes.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Publication of neurology clinical trials registered with clinical trial registry of India: A cross‐sectional study

Mishra

Agarwal

Nilima

et al. 2022

Acta Neuro Scandinavica

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“…Research priority setting could also help identify areas where there is a need to address known trials methodology issues. For instance, TMR on the reporting of trial results has consistently shown that a large proportion of Indian clinical trials registered on the CTRI remain unpublished, 44 , 45 emphasising the need for regulations to mandate the timely publication of trial results. Along the same vein, an observational TMR study published in 2013 to evaluate the reporting quality of RCTs found that methods reporting was better in the CTRI than in Indian journal publications, with the latter demonstrating suboptimal compliance with Consolidated Standards for the Reporting of Trials (CONSORT) and International Committee of Medical Journal Editors (ICJME) requirements.…”

Section: What Could Be Achieved If There Was Strategic Funding For Tm...mentioning

confidence: 99%

Trials Methodology Research: what is it and why should India invest in it?

Paramasivan,

Bhan,

Rodrigues

et al. 2024

The Lancet Regional Health - Southeast Asia

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“…1 We recently published a research study that investigated publication rates of clinical trials in the CTRI. 4 We identified cancer clinical trials registered in CTRI till February 2016. In doing so, we ensured that there was enough time for the trials to be published since the manuscript search started in December 2019.…”

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confidence: 99%