ArticleBMJ open2022
Planned, ongoing and completed tuberculosis treatment trials in Brazil, Russia, India, China and South Africa: a 2019 cross-sectional descriptive analysis.
Article in BMJ open, 2022. 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
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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.
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0 citing papers in PubMed, 1 citations in OpenAlex.
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Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Tuberculosis (TB) remains a deadly challenge globally and Brazil, Russia, India, China and South Africa (BRICS) are among the countries with the highest TB burden. The objective of this study is to identify and describe ongoing, planned and completed TB trials conducted in the BRICS countries registered in WHO-International Clinical Trial Registry Platform (WHO-ICTRP); to report selective outcome reporting by comparing primary outcomes in published trials with their prespecified outcomes in registry records and to evaluate the time to publication. METHODS AND ANALYSIS: We searched the WHO-ICTRP portal (20 January 2019) and the Russian Federation Registry (30 March 2019) to identify TB trials conducted in BRICS countries. We included only registered clinical trials conducted wholly in BRICS countries or with at least one recruitment centre in one of the BRICS countries that were investigating TB treatment.
resultsThe search of the WHO-ICTRP yielded 408 trials and additional 32 trials were identified from the Russian registry. Of those, 253 were included in the analysis. We found that 77 trials were multicountry trials, followed by trials in China (55), India (53), South Africa (34), Russia (23) and Brazil (11). 163 trials were registered prospectively, 69 retrospectively and 21 trials had no registration status. Most trials (207) evaluated TB treatment, followed by 29 behaviour change interventions, 13 nutritional supplementation, 4 surgical treatment and 2 assessing rehabilitation. Based on ICJME recommendation of publishing 12 months after completion of trial, we found that 156 trials were completed 12 or more months by date and 101 trials had publications. Thirty-one of the 101 trials with publication had evidence of selective outcome reporting. The median time to publication was 25 months (IQR 15-37) from the time of anticipated end date stated in the registry.
conclusionTB trials conducted in BRICS countries are collaborative, mostly drug treatment oriented, potentially affecting policies. Selective outcome reporting remains a problem both for prospectively and retrospectively registered trials, only small fraction of which gets to publication.
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