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

Autor:	van der Naald M; Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands., Chamuleau SAJ; Department of Cardiology, Amsterdam UMC Locatie AMC, Amsterdam, North Holland, The Netherlands.; Netherlands Heart Institute, Utrecht, The Netherlands., Menon JML; Netherlands Heart Institute, Utrecht, The Netherlands., de Leeuw W; Animal Welfare Body Utrecht, Utrecht, The Netherlands., de Haan J; Open Science Programme, Utrecht University, Utrecht, The Netherlands., Duncker DJ; Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands., Wever KE; Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE), Department for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands.; Department of Anesthesiology, Radboud University Medical Center, Nijmegen, The Netherlands.
Jazyk:	angličtina
Zdroj:	BMJ open science [BMJ Open Sci] 2022 Mar 16; Vol. 6 (1), pp. e100259. Date of Electronic Publication: 2022 Mar 16 (Print Publication: 2022).
DOI:	10.1136/bmjos-2021-100259
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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