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Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study

BACKGROUND: The results of clinical trials should be completely and rapidly reported during public health emergencies such as COVID-19. This study aimed to examine when, and where, the results of COVID-19 clinical trials were disseminated throughout the first 18 months of the pandemic. METHODS: Clin...

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Autores principales: Salholz-Hillel, Maia, Pugh-Jones, Molly, Hildebrand, Nicole, Schult, Tjada A., Schwietering, Johannes, Grabitz, Peter, Carlisle, Benjamin Gregory, Goldacre, Ben, Strech, Daniel, DeVito, Nicholas J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10687901/
https://www.ncbi.nlm.nih.gov/pubmed/38031096
http://dx.doi.org/10.1186/s12916-023-03161-6
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author Salholz-Hillel, Maia
Pugh-Jones, Molly
Hildebrand, Nicole
Schult, Tjada A.
Schwietering, Johannes
Grabitz, Peter
Carlisle, Benjamin Gregory
Goldacre, Ben
Strech, Daniel
DeVito, Nicholas J.
author_facet Salholz-Hillel, Maia
Pugh-Jones, Molly
Hildebrand, Nicole
Schult, Tjada A.
Schwietering, Johannes
Grabitz, Peter
Carlisle, Benjamin Gregory
Goldacre, Ben
Strech, Daniel
DeVito, Nicholas J.
author_sort Salholz-Hillel, Maia
collection PubMed
description BACKGROUND: The results of clinical trials should be completely and rapidly reported during public health emergencies such as COVID-19. This study aimed to examine when, and where, the results of COVID-19 clinical trials were disseminated throughout the first 18 months of the pandemic. METHODS: Clinical trials for COVID-19 treatment or prevention were identified from the WHO ICTRP database. All interventional trials with a registered completion date ≤ 30 June 2021 were included. Trial results, published as preprints, journal articles, or registry results, were located using automated and manual techniques across PubMed, Google Scholar, Google, EuropePMC, CORD-19, the Cochrane COVID-19 Study Register, and clinical trial registries. Our main analysis reports the rate of dissemination overall and per route, and the time from registered completion to results using Kaplan–Meier methods, with additional subgroup and sensitivity analyses reported. RESULTS: Overall, 1643 trials with completion dates ranging from 46 to 561 days prior to the start of results searches were included. The cumulative probability of reporting was 12.5% at 3 months from completion, 21.6% at 6 months, and 32.8% at 12 months. Trial results were most commonly disseminated in journals (n = 278 trials, 69.2%); preprints were available for 194 trials (48.3%), 86 (44.3%) of which converted to a full journal article. Trials completed earlier in the pandemic were reported more rapidly than those later in the pandemic, and those involving ivermectin were more rapidly reported than other common interventions. Results were robust to various sensitivity analyses except when considering only trials in a “completed” status on the registry, which substantially increased reporting rates. Poor trial registry data on completion status and dates limits the precision of estimates. CONCLUSIONS: COVID-19 trials saw marginal increases in reporting rates compared to standard practice; most registered trials failed to meet even the 12-month non-pandemic standard. Preprints were common, complementing journal publication; however, registries were underutilized for rapid reporting. Maintaining registry data enables accurate representation of clinical research; failing to do so undermines these registries’ use for public accountability and analysis. Addressing rapid reporting and registry data quality must be emphasized at global, national, and institutional levels. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-023-03161-6.
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spelling pubmed-106879012023-11-30 Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study Salholz-Hillel, Maia Pugh-Jones, Molly Hildebrand, Nicole Schult, Tjada A. Schwietering, Johannes Grabitz, Peter Carlisle, Benjamin Gregory Goldacre, Ben Strech, Daniel DeVito, Nicholas J. BMC Med Research Article BACKGROUND: The results of clinical trials should be completely and rapidly reported during public health emergencies such as COVID-19. This study aimed to examine when, and where, the results of COVID-19 clinical trials were disseminated throughout the first 18 months of the pandemic. METHODS: Clinical trials for COVID-19 treatment or prevention were identified from the WHO ICTRP database. All interventional trials with a registered completion date ≤ 30 June 2021 were included. Trial results, published as preprints, journal articles, or registry results, were located using automated and manual techniques across PubMed, Google Scholar, Google, EuropePMC, CORD-19, the Cochrane COVID-19 Study Register, and clinical trial registries. Our main analysis reports the rate of dissemination overall and per route, and the time from registered completion to results using Kaplan–Meier methods, with additional subgroup and sensitivity analyses reported. RESULTS: Overall, 1643 trials with completion dates ranging from 46 to 561 days prior to the start of results searches were included. The cumulative probability of reporting was 12.5% at 3 months from completion, 21.6% at 6 months, and 32.8% at 12 months. Trial results were most commonly disseminated in journals (n = 278 trials, 69.2%); preprints were available for 194 trials (48.3%), 86 (44.3%) of which converted to a full journal article. Trials completed earlier in the pandemic were reported more rapidly than those later in the pandemic, and those involving ivermectin were more rapidly reported than other common interventions. Results were robust to various sensitivity analyses except when considering only trials in a “completed” status on the registry, which substantially increased reporting rates. Poor trial registry data on completion status and dates limits the precision of estimates. CONCLUSIONS: COVID-19 trials saw marginal increases in reporting rates compared to standard practice; most registered trials failed to meet even the 12-month non-pandemic standard. Preprints were common, complementing journal publication; however, registries were underutilized for rapid reporting. Maintaining registry data enables accurate representation of clinical research; failing to do so undermines these registries’ use for public accountability and analysis. Addressing rapid reporting and registry data quality must be emphasized at global, national, and institutional levels. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-023-03161-6. BioMed Central 2023-11-29 /pmc/articles/PMC10687901/ /pubmed/38031096 http://dx.doi.org/10.1186/s12916-023-03161-6 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Salholz-Hillel, Maia
Pugh-Jones, Molly
Hildebrand, Nicole
Schult, Tjada A.
Schwietering, Johannes
Grabitz, Peter
Carlisle, Benjamin Gregory
Goldacre, Ben
Strech, Daniel
DeVito, Nicholas J.
Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study
title Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study
title_full Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study
title_fullStr Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study
title_full_unstemmed Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study
title_short Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study
title_sort dissemination of registered covid-19 clinical trials (direcct): a cross-sectional study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10687901/
https://www.ncbi.nlm.nih.gov/pubmed/38031096
http://dx.doi.org/10.1186/s12916-023-03161-6
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