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Assessing the Integrity of Clinical Trials Included in Evidence Syntheses

Evidence syntheses of randomized clinical trials (RCTs) offer the highest level of scientific evidence for informing clinical practice and policy. The value of evidence synthesis itself depends on the trustworthiness of the included RCTs. The rising number of retractions and expressions of concern a...

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Autores principales: Núñez-Núñez, María, Cano-Ibáñez, Naomi, Zamora, Javier, Bueno-Cavanillas, Aurora, Khan, Khalid Saeed
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10298200/
https://www.ncbi.nlm.nih.gov/pubmed/37372725
http://dx.doi.org/10.3390/ijerph20126138
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author Núñez-Núñez, María
Cano-Ibáñez, Naomi
Zamora, Javier
Bueno-Cavanillas, Aurora
Khan, Khalid Saeed
author_facet Núñez-Núñez, María
Cano-Ibáñez, Naomi
Zamora, Javier
Bueno-Cavanillas, Aurora
Khan, Khalid Saeed
author_sort Núñez-Núñez, María
collection PubMed
description Evidence syntheses of randomized clinical trials (RCTs) offer the highest level of scientific evidence for informing clinical practice and policy. The value of evidence synthesis itself depends on the trustworthiness of the included RCTs. The rising number of retractions and expressions of concern about the authenticity of RCTs has raised awareness about the existence of problematic studies, sometimes called “zombie” trials. Research integrity, i.e., adherence to ethical and professional standards, is a multi-dimensional concept that is incompletely evaluated for the RCTs included in current evidence syntheses. Systematic reviewers tend to rely on the editorial and peer-review system established by journals as custodians of integrity of the RCTs they synthesize. It is now well established that falsified and fabricated RCTs are slipping through. Thus, RCT integrity assessment becomes a necessary step in systematic reviews going forward, in particular because RCTs with data-related integrity concerns remain available for use in evidence syntheses. There is a need for validated tools for systematic reviewers to proactively deploy in the assessment of integrity deviations without having to wait for RCTs to be retracted by journals or expressions of concern issued. This article analyzes the issues and challenges in conducting evidence syntheses where the literature contains RCTs with possible integrity deficits. The way forward in the form of formal RCT integrity assessments in systematic reviews is proposed, and implications of this new initiative are discussed. Future directions include emphasizing ethical and professional standards, providing tailored integrity-specific training, and creating systems to promote research integrity, as improvements in RCT integrity will benefit evidence syntheses.
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spelling pubmed-102982002023-06-28 Assessing the Integrity of Clinical Trials Included in Evidence Syntheses Núñez-Núñez, María Cano-Ibáñez, Naomi Zamora, Javier Bueno-Cavanillas, Aurora Khan, Khalid Saeed Int J Environ Res Public Health Review Evidence syntheses of randomized clinical trials (RCTs) offer the highest level of scientific evidence for informing clinical practice and policy. The value of evidence synthesis itself depends on the trustworthiness of the included RCTs. The rising number of retractions and expressions of concern about the authenticity of RCTs has raised awareness about the existence of problematic studies, sometimes called “zombie” trials. Research integrity, i.e., adherence to ethical and professional standards, is a multi-dimensional concept that is incompletely evaluated for the RCTs included in current evidence syntheses. Systematic reviewers tend to rely on the editorial and peer-review system established by journals as custodians of integrity of the RCTs they synthesize. It is now well established that falsified and fabricated RCTs are slipping through. Thus, RCT integrity assessment becomes a necessary step in systematic reviews going forward, in particular because RCTs with data-related integrity concerns remain available for use in evidence syntheses. There is a need for validated tools for systematic reviewers to proactively deploy in the assessment of integrity deviations without having to wait for RCTs to be retracted by journals or expressions of concern issued. This article analyzes the issues and challenges in conducting evidence syntheses where the literature contains RCTs with possible integrity deficits. The way forward in the form of formal RCT integrity assessments in systematic reviews is proposed, and implications of this new initiative are discussed. Future directions include emphasizing ethical and professional standards, providing tailored integrity-specific training, and creating systems to promote research integrity, as improvements in RCT integrity will benefit evidence syntheses. MDPI 2023-06-15 /pmc/articles/PMC10298200/ /pubmed/37372725 http://dx.doi.org/10.3390/ijerph20126138 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Núñez-Núñez, María
Cano-Ibáñez, Naomi
Zamora, Javier
Bueno-Cavanillas, Aurora
Khan, Khalid Saeed
Assessing the Integrity of Clinical Trials Included in Evidence Syntheses
title Assessing the Integrity of Clinical Trials Included in Evidence Syntheses
title_full Assessing the Integrity of Clinical Trials Included in Evidence Syntheses
title_fullStr Assessing the Integrity of Clinical Trials Included in Evidence Syntheses
title_full_unstemmed Assessing the Integrity of Clinical Trials Included in Evidence Syntheses
title_short Assessing the Integrity of Clinical Trials Included in Evidence Syntheses
title_sort assessing the integrity of clinical trials included in evidence syntheses
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10298200/
https://www.ncbi.nlm.nih.gov/pubmed/37372725
http://dx.doi.org/10.3390/ijerph20126138
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