Overcoming publication and dissemination bias in infectious diseases clinical trials.

Autor:	Grobusch MP; Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands; Institute of Tropical Medicine, German Centre for Infection Research (DZIF), University of Tübingen, Tübingen, Germany; Centre de Recherches Médicales en Lambaréné (CERMEL), Lambaréné, Gabon; Masanga Medical Research Unit (MMRU), Masanga, Sierra Leone; Institute of Infectious Diseases and Molecular Medicine (IDM), University of Cape Town, Cape Town, South Africa. Electronic address: m.p.grobusch@amsterdamumc.nl., Ruiz Del Portal Luyten C; Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands., Visser BJ; Instituut voor Tropische Geneeskunde, Antwerp, Belgium., de Jong HK; Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands., Goorhuis A; Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands., Hanscheid T; Instituto de Microbiologia, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.
Jazyk:	angličtina
Zdroj:	The Lancet. Infectious diseases [Lancet Infect Dis] 2024 Mar; Vol. 24 (3), pp. e189-e195. Date of Electronic Publication: 2023 Oct 11.
DOI:	10.1016/S1473-3099(23)00455-3
Abstrakt:	Non-timely reporting, selective reporting, or non-reporting of clinical trial results are prevalent and serious issues. WHO mandates that summary results be available in registries within 12 months of study completion and published in full text within 24 months. However, only a limited number of clinical trials in infectious diseases, including those done during the COVID-19 pandemic, have their results posted on ClinicalTrials.gov. An analysis of 50 trials of eight antiviral drugs tested against COVID-19 with a completion date of at least 2 years ago revealed that only 18% had their results published in the registry, with 40% not publishing any results. Non-timely and non-reporting practices undermine patient participation and are ethically unacceptable. Strategies should include obligatory reporting of summary results within 12 months in clinical trial registries, with progress towards peer-reviewed publication within 24 months indicated. Timely publication of research papers should be encouraged through an automated flagging mechanism in clinical trial registries that draws attention to the status of results reporting, such as a green tick for trials that have reported summary results within 12 months and a red tick in case of failure to do so. We propose the inclusion of mandatory clinical trial reporting standards in the International Conference on Harmonization Good Clinical Practice guidelines, which should prohibit sponsor contract clauses that restrict reporting (referred to as gag clauses) and require timely reporting of results as part of the ethics committees' clearance process for clinical trial protocols. Competing Interests: Declaration of interests MPG was Amsterdam site principal investigator on remdesivir trials for patients with moderate (NCT04292730) and severe (NCT04292899) COVID-19 (all fees paid to the institution). All other authors declare no competing interests. (Copyright © 2024 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
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