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What discontinued trials teach us about trial registration?
OBJECTIVE: Trial registries were set up to improve transparency, remove duplication, improve awareness and avoid waste. Many trials never reach the point of patient enrolment due to a myriad of reasons. The aim of this study was to investigate the reasons for and characteristics of discontinuation o...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7863519/ https://www.ncbi.nlm.nih.gov/pubmed/33546746 http://dx.doi.org/10.1186/s13104-020-05391-w |
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author | Vellinga, Akke Lambe, Kathryn O’Connor, Paul O’Dea, Angela |
author_facet | Vellinga, Akke Lambe, Kathryn O’Connor, Paul O’Dea, Angela |
author_sort | Vellinga, Akke |
collection | PubMed |
description | OBJECTIVE: Trial registries were set up to improve transparency, remove duplication, improve awareness and avoid waste. Many trials never reach the point of patient enrolment due to a myriad of reasons. The aim of this study was to investigate the reasons for and characteristics of discontinuation of trials. RESULTS: A total of 163 discontinued trials were identified and compared to completed trials. A Survey was designed to further explore the nature and conduct of the trial. No differences in registered and categorised information was observed between discontinued and completed trials. Most trials discontinue due to patient or participant recruitment issues, often related to funding. Substantial changes to procedures or the protocol or changes to recruitment strategy were also commonly cited reasons. Survey information was available for 21 discontinued and 28 completed trials and no obvious differences could be identified. Our findings highlight the underlying problem of lack of detail, suboptimal recording, dated information and incomplete reporting of trials within a trial registry which hampers sharing and learning. To date, important progress has been made by the implementation of standards and the requirement of trials to be registered. Our review identifies areas where further improvements can be made. |
format | Online Article Text |
id | pubmed-7863519 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-78635192021-02-08 What discontinued trials teach us about trial registration? Vellinga, Akke Lambe, Kathryn O’Connor, Paul O’Dea, Angela BMC Res Notes Research Note OBJECTIVE: Trial registries were set up to improve transparency, remove duplication, improve awareness and avoid waste. Many trials never reach the point of patient enrolment due to a myriad of reasons. The aim of this study was to investigate the reasons for and characteristics of discontinuation of trials. RESULTS: A total of 163 discontinued trials were identified and compared to completed trials. A Survey was designed to further explore the nature and conduct of the trial. No differences in registered and categorised information was observed between discontinued and completed trials. Most trials discontinue due to patient or participant recruitment issues, often related to funding. Substantial changes to procedures or the protocol or changes to recruitment strategy were also commonly cited reasons. Survey information was available for 21 discontinued and 28 completed trials and no obvious differences could be identified. Our findings highlight the underlying problem of lack of detail, suboptimal recording, dated information and incomplete reporting of trials within a trial registry which hampers sharing and learning. To date, important progress has been made by the implementation of standards and the requirement of trials to be registered. Our review identifies areas where further improvements can be made. BioMed Central 2021-02-05 /pmc/articles/PMC7863519/ /pubmed/33546746 http://dx.doi.org/10.1186/s13104-020-05391-w Text en © The Author(s) 2021 Open AccessThis 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/. The Creative Commons Public Domain Dedication waiver (http://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 Note Vellinga, Akke Lambe, Kathryn O’Connor, Paul O’Dea, Angela What discontinued trials teach us about trial registration? |
title | What discontinued trials teach us about trial registration? |
title_full | What discontinued trials teach us about trial registration? |
title_fullStr | What discontinued trials teach us about trial registration? |
title_full_unstemmed | What discontinued trials teach us about trial registration? |
title_short | What discontinued trials teach us about trial registration? |
title_sort | what discontinued trials teach us about trial registration? |
topic | Research Note |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7863519/ https://www.ncbi.nlm.nih.gov/pubmed/33546746 http://dx.doi.org/10.1186/s13104-020-05391-w |
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