A 3-year evaluation of preclinicaltrials.eu reveals room for improvement in preregistration of animal studies

Naald, Mira van der; Chamuleau, Steven A.J.; Menon, Julia M. L.; Leeuw, Wim de; Haan, Judith J. de; Duncker, Dirk J.; Wever, Kimberley E.

doi:10.1371/journal.pbio.3001397

Cited by 8 publications

(5 citation statements)

References 8 publications

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“…Preregistration has been a commonly used practice in research for some time in several different research disciplines, such as psychology ( Nosek et al, 2018 ), biomedical research ( Serghiou et al, 2023 ), applied research ( Evans et al, 2023 ), and animal research ( van der Naald et al, 2021 ), among others. A registry specifically designed for collation of HBM studies performed worldwide prior to data being collected/accessed (i.e., preregistration of HBM studies) is currently lacking.…”

Section: Challengesmentioning

confidence: 99%

FAIR environmental and health registry (FAIREHR)- supporting the science to policy interface and life science research, development and innovation

et al. 2023

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The environmental impact on health is an inevitable by-product of human activity. Environmental health sciences is a multidisciplinary field addressing complex issues on how people are exposed to hazardous chemicals that can potentially affect adversely the health of present and future generations. Exposure sciences and environmental epidemiology are becoming increasingly data-driven and their efficiency and effectiveness can significantly improve by implementing the FAIR (findable, accessible, interoperable, reusable) principles for scientific data management and stewardship. This will enable data integration, interoperability and (re)use while also facilitating the use of new and powerful analytical tools such as artificial intelligence and machine learning in the benefit of public health policy, and research, development and innovation (RDI). Early research planning is critical to ensuring data is FAIR at the outset. This entails a well-informed and planned strategy concerning the identification of appropriate data and metadata to be gathered, along with established procedures for their collection, documentation, and management. Furthermore, suitable approaches must be implemented to evaluate and ensure the quality of the data. Therefore, the ‘Europe Regional Chapter of the International Society of Exposure Science’ (ISES Europe) human biomonitoring working group (ISES Europe HBM WG) proposes the development of a FAIR Environment and health registry (FAIREHR) (hereafter FAIREHR). FAIR Environment and health registry offers preregistration of studies on exposure sciences and environmental epidemiology using HBM (as a starting point) across all areas of environmental and occupational health globally. The registry is proposed to receive a dedicated web-based interface, to be electronically searchable and to be available to all relevant data providers, users and stakeholders. Planned Human biomonitoring studies would ideally be registered before formal recruitment of study participants. The resulting FAIREHR would contain public records of metadata such as study design, data management, an audit trail of major changes to planned methods, details of when the study will be completed, and links to resulting publications and data repositories when provided by the authors. The FAIREHR would function as an integrated platform designed to cater to the needs of scientists, companies, publishers, and policymakers by providing user-friendly features. The implementation of FAIREHR is expected to yield significant benefits in terms of enabling more effective utilization of human biomonitoring (HBM) data.

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Section: Challengesmentioning

confidence: 99%

FAIR environmental and health registry (FAIREHR)- supporting the science to policy interface and life science research, development and innovation

et al. 2023

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“…To promote preregistration among researchers, we will provide webinars and aim to develop e-learning tools. We also create promotional material and publish relevant information online, in collaborators’ newsletters or via short communications 1. Institutions, animal ethics committees and animal welfare bodies will be approached to aid in promoting preregistration and reward good behaviour.…”

Section: The Future Of Preclinical Preregistrationmentioning

confidence: 99%

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

et al. 2022

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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.

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“…Some open preregistration platforms also provide a digital object identifier (DOI), which makes the registered study citable. Three public registries actively encourage the preregistration of animal studies conducted around the world: OSF registry, preclinicaltrials.eu, and animalstudyregistry.org [41][42][43][44][45]. Scientists can choose the registry according to their needs.…”

Section: Preregistrationmentioning

confidence: 99%

A guide to open science practices for animal research

et al. 2022

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Translational biomedical research relies on animal experiments and provides the underlying proof of practice for clinical trials, which places an increased duty of care on translational researchers to derive the maximum possible output from every experiment performed. The implementation of open science practices has the potential to initiate a change in research culture that could improve the transparency and quality of translational research in general, as well as increasing the audience and scientific reach of published research. However, open science has become a buzzword in the scientific community that can often miss mark when it comes to practical implementation. In this Essay, we provide a guide to open science practices that can be applied throughout the research process, from study design, through data collection and analysis, to publication and dissemination, to help scientists improve the transparency and quality of their work. As open science practices continue to evolve, we also provide an online toolbox of resources that we will update continually.

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A 3-year evaluation of preclinicaltrials.eu reveals room for improvement in preregistration of animal studies

Abstract: In 2018, the first registry dedicated to preregistration of animal study protocols was launched. Despite international support, the overall number of (pre)registered protocols is still low, illustrating the need for pushing the preregistration agenda among researchers and policymakers.

Cited by 8 publications

References 8 publications

FAIR environmental and health registry (FAIREHR)- supporting the science to policy interface and life science research, development and innovation

FAIR environmental and health registry (FAIREHR)- supporting the science to policy interface and life science research, development and innovation

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

A guide to open science practices for animal research

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