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Exploring trial publication and research waste in COVID-19 randomised trials of hydroxychloroquine, corticosteroids, and vitamin D: a meta-epidemiological cohort study

Fincham et al., BMC Medical Research Methodology, doi:10.1186/s12874-023-02110-4
Jan 2024  
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HCQ for COVID-19
1st treatment shown to reduce risk in March 2020
 
*, now with p < 0.00000000001 from 411 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 75 treatments. c19hcq.org
Analysis of 357 HCQ, vitamin D, and corticosteroid COVID-19 RCTs registered before the end of 2021, showing that 70% had not published results as of October 2022.
70% of HCQ, 65% of vitamin D, and 72% of corticosteroid trials had not published results.
Study covers HCQ and vitamin D.
Fincham et al., 23 Jan 2024, peer-reviewed, 5 authors. Contact: lisa.fincham@gmail.com.
This PaperHCQAll
Exploring trial publication and research waste in COVID-19 randomised trials of hydroxychloroquine, corticosteroids, and vitamin D: a meta-epidemiological cohort study
Lisa Fincham, Ameer Hohlfeld, Mike Clarke, Tamara Kredo, Michael Mccaul
BMC Medical Research Methodology, doi:10.1186/s12874-023-02110-4
Background The global research response to the COVID-19 pandemic was impressive, but also led to an infodemic and considerable research waste. Registered, but unpublished trials added to this noise. We aimed to determine the proportion of registered randomised trials of common COVID-19 treatments that were published and to describe the characteristics of these trials to examine the association between trial characteristics, publication status and research waste. Methods This meta-epidemiological cohort study used a sample of randomised trials of corticosteroids, hydroxychloroquine or vitamin D as treatments for COVID-19, registered between 1 November 2019 and 31 December 2021 and available via the WHO ICTRP portal. We searched for the trials' published results up to 20 October 2022. We extracted the trial characteristics, analysing with descriptive statistics. We performed univariate logistic regression to examine the association between trials' characteristics and publication status, followed by multiple logistic regression using significant characteristics to assess the association between trial characteristics and publication status. Results We identified 357 eligible trials on ICTRP. Of these, 107 (30%) had published or made their results available publicly by 20 October 2022, while 250 (70%) had not been published or shared their results publicly. Multiple logistic regression analysis showed that a larger target sample size was a significant positive predictor of publication with target sample sizes above 300 almost tripling the odds of publication (aOR: 2.75, 95% CI: 1.35 to 5.62). Conclusions Less than one third of registered trials made their results public and our findings identified that many trialists had not updated their trial registry entry with the trial status, results or both. Failure to share trial results publicly is a disservice to patients, clinicians and policy makers and adds to research waste.
Supplementary Information The online version contains supplementary material available at https://doi. org/10.1186/s12874-023-02110-4. Supplementary Material 1 Supplementary Material 2 Authors' contributions Funding TK is partly supported by the Research, Evidence and Development Initiative (READ-It) project (project number 300342-104) which is funded by UK aid from the UK government; however, the views expressed do not necessarily reflect the UK government's official policies. Data availability The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Declarations Ethics approval and consent to participate Not applicable (HEA-2022-26347). Consent for publication Not applicable. Competing interests The authors declare no competing interests. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Registered, but unpublished ' 'trials added to this noise. We aimed to determine the proportion of registered randomised ' 'trials of common COVID-19 treatments that were published and to describe the characteristics ' 'of these trials to examine the association between trial characteristics, publication status ' 'and research waste.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>This meta-epidemiological cohort study used a sample of randomised ' 'trials of corticosteroids, hydroxychloroquine or vitamin D as treatments for COVID-19, ' 'registered between 1 November 2019 and 31 December 2021 and available via the WHO ICTRP ' 'portal. We searched for the trials’ published results up to 20 October 2022. We extracted the ' 'trial characteristics, analysing with descriptive statistics. We performed univariate ' 'logistic regression to examine the association between trials’ characteristics and ' 'publication status, followed by multiple logistic regression using significant ' 'characteristics to assess the association between trial characteristics and publication ' 'status.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>We identified 357 eligible trials on ICTRP. Of these, 107 (30%) had ' 'published or made their results available publicly by 20 October 2022, while 250 (70%) had ' 'not been published or shared their results publicly. Multiple logistic regression analysis ' 'showed that a larger target sample size was a significant positive predictor of publication ' 'with target sample sizes above 300 almost tripling the odds of publication (aOR: 2.75, 95% ' 'CI: 1.35 to 5.62).</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>Less than one third of registered trials made their results public ' 'and our findings identified that many trialists had not updated their trial registry entry ' 'with the trial status, results or both. 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