Cargando…

Preregistration of animal research protocols: development and 3-year overview of preclinicaltrials.eu

Open, prospective registration of a study protocol can improve research rigour in a number of ways. Through preregistration, key features of the study’s methodology are recorded and maintained as a permanent record, enabling comparison of the completed study with what was planned. By recording the s...

Descripción completa

Detalles Bibliográficos
Autores principales: van der Naald, Mira, Chamuleau, Steven A J, Menon, Julia M L, de Leeuw, Wim, de Haan, Judith, Duncker, Dirk J, Wever, Kimberley Elaine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8928250/
https://www.ncbi.nlm.nih.gov/pubmed/35372701
http://dx.doi.org/10.1136/bmjos-2021-100259
_version_ 1784670603039473664
author van der Naald, Mira
Chamuleau, Steven A J
Menon, Julia M L
de Leeuw, Wim
de Haan, Judith
Duncker, Dirk J
Wever, Kimberley Elaine
author_facet van der Naald, Mira
Chamuleau, Steven A J
Menon, Julia M L
de Leeuw, Wim
de Haan, Judith
Duncker, Dirk J
Wever, Kimberley Elaine
author_sort van der Naald, Mira
collection PubMed
description Open, prospective registration of a study protocol can improve research rigour in a number of ways. Through preregistration, key features of the study’s methodology are recorded and maintained as a permanent record, enabling comparison of the completed study with what was planned. By recording the study hypothesis and planned outcomes a priori, preregistration creates transparency and can reduce the risk of several common biases, such as hypothesising after results are known and outcome switching or selective outcome reporting. Second, preregistration raises awareness of measures to reduce bias, such as randomisation and blinding. Third, preregistration provides a comprehensive listing of planned studies, which can prevent unnecessary duplication and reduce publication bias. Although commonly acknowledged and applied in clinical research since 2000, preregistration of animal studies is not yet the norm. In 2018 we launched the first dedicated, open, online register for animal study protocols: wwwpreclinicaltrialseu. Here, we provide insight in the development of preclinicaltrials.eu (PCT) and evaluate its use during the first 3 years after its launch. Furthermore, we elaborate on ongoing developments such as the rise of comparable registries, increasing support for preregistration in the Netherlands—which led to the funding of PCT by the Dutch government—and pilots of mandatory preregistration by several funding bodies. We show the international coverage of currently registered protocols but with the overall low number of (pre)registered protocols.
format Online
Article
Text
id pubmed-8928250
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-89282502022-04-01 Preregistration of animal research protocols: development and 3-year overview of preclinicaltrials.eu van der Naald, Mira Chamuleau, Steven A J Menon, Julia M L de Leeuw, Wim de Haan, Judith Duncker, Dirk J Wever, Kimberley Elaine BMJ Open Sci Review Open, prospective registration of a study protocol can improve research rigour in a number of ways. Through preregistration, key features of the study’s methodology are recorded and maintained as a permanent record, enabling comparison of the completed study with what was planned. By recording the study hypothesis and planned outcomes a priori, preregistration creates transparency and can reduce the risk of several common biases, such as hypothesising after results are known and outcome switching or selective outcome reporting. Second, preregistration raises awareness of measures to reduce bias, such as randomisation and blinding. Third, preregistration provides a comprehensive listing of planned studies, which can prevent unnecessary duplication and reduce publication bias. Although commonly acknowledged and applied in clinical research since 2000, preregistration of animal studies is not yet the norm. In 2018 we launched the first dedicated, open, online register for animal study protocols: wwwpreclinicaltrialseu. Here, we provide insight in the development of preclinicaltrials.eu (PCT) and evaluate its use during the first 3 years after its launch. Furthermore, we elaborate on ongoing developments such as the rise of comparable registries, increasing support for preregistration in the Netherlands—which led to the funding of PCT by the Dutch government—and pilots of mandatory preregistration by several funding bodies. We show the international coverage of currently registered protocols but with the overall low number of (pre)registered protocols. BMJ Publishing Group 2022-03-16 /pmc/articles/PMC8928250/ /pubmed/35372701 http://dx.doi.org/10.1136/bmjos-2021-100259 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Review
van der Naald, Mira
Chamuleau, Steven A J
Menon, Julia M L
de Leeuw, Wim
de Haan, Judith
Duncker, Dirk J
Wever, Kimberley Elaine
Preregistration of animal research protocols: development and 3-year overview of preclinicaltrials.eu
title Preregistration of animal research protocols: development and 3-year overview of preclinicaltrials.eu
title_full Preregistration of animal research protocols: development and 3-year overview of preclinicaltrials.eu
title_fullStr Preregistration of animal research protocols: development and 3-year overview of preclinicaltrials.eu
title_full_unstemmed Preregistration of animal research protocols: development and 3-year overview of preclinicaltrials.eu
title_short Preregistration of animal research protocols: development and 3-year overview of preclinicaltrials.eu
title_sort preregistration of animal research protocols: development and 3-year overview of preclinicaltrials.eu
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8928250/
https://www.ncbi.nlm.nih.gov/pubmed/35372701
http://dx.doi.org/10.1136/bmjos-2021-100259
work_keys_str_mv AT vandernaaldmira preregistrationofanimalresearchprotocolsdevelopmentand3yearoverviewofpreclinicaltrialseu
AT chamuleaustevenaj preregistrationofanimalresearchprotocolsdevelopmentand3yearoverviewofpreclinicaltrialseu
AT menonjuliaml preregistrationofanimalresearchprotocolsdevelopmentand3yearoverviewofpreclinicaltrialseu
AT deleeuwwim preregistrationofanimalresearchprotocolsdevelopmentand3yearoverviewofpreclinicaltrialseu
AT dehaanjudith preregistrationofanimalresearchprotocolsdevelopmentand3yearoverviewofpreclinicaltrialseu
AT dunckerdirkj preregistrationofanimalresearchprotocolsdevelopmentand3yearoverviewofpreclinicaltrialseu
AT weverkimberleyelaine preregistrationofanimalresearchprotocolsdevelopmentand3yearoverviewofpreclinicaltrialseu