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

['Mira Van Der Naald', 'Department Of Cardiology', 'University Medical Center Utrecht', 'Utrecht', 'The Netherlands', 'Steven A. J. Chamuleau', 'Amsterdam University Medical Center', 'Amsterdam', 'Netherlands Heart Institute', 'Julia M. L. Menon']

Date: 2021-10

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.

Citation: van der Naald M, Chamuleau SAJ, Menon JML, de Leeuw W, de Haan JJ, Duncker DJ, et al. (2021) A 3-year evaluation of preclinicaltrials.eu reveals room for improvement in preregistration of animal studies. PLoS Biol 19(9): e3001397. https://doi.org/10.1371/journal.pbio.3001397 Published: September 9, 2021 Copyright: © 2021 van der Naald et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Funding: The author(s) received no specific funding for this work. Competing interests: The authors have declared that no competing interests exist. Abbreviations: Bf3R, German Centre for the Protection of Laboratory Animals; HARKing, hypothesising after results are known; UMCU, University Medical Center Utrecht; ZonMw, the Netherlands Organisation for Health Research and Development

Why preregistration benefits research Reporting of animal studies is poor, including incomplete reporting of study details, measures to reduce bias, and statistical analyses [1]. Poor reporting obscures the true state of affairs in animal studies, rendering external validity, internal validity, and statistical robustness and power largely unclear. The limitations found within studies are further exacerbated by reporting biases such as publication bias and selective outcome reporting. The publication rate of animal studies is limited to 60% to 67%, and, especially, studies yielding “negative” results remain unpublished [2–4]. Simultaneously, the underreporting of the number of animals used in publications suggests that data are reported selectively, an indication of outcome reporting bias [2]. Outcome switching and HARKing (hypothesising after results are known) are additional forms of bias known to be present in clinical research, and animal research is unlikely to be immune to these biases. Registration of a protocol before starting an experiment (preregistration) plays an essential role in improving robustness and transparency of animal studies and leads to more reliable results. Such preregistration of preclinical studies has 4 main benefits: disclosing the a priori study intention, i.e., hypothesis, exploratory or confirmatory character, and key elements of its design, including primary and secondary outcomes and sample size calculations; promoting the use of methods to reduce risks of bias (i.e., blinding and randomisation) and creating transparency about their use; providing a complete overview of all performed studies (including those that remain unpublished) and the possibility to share or link to related data; and creating transparency and accountability within the research community and towards society.

The development of preclinicaltrials.eu In 2018, we launched the first online registry dedicated to animal study protocols: www.preclinicaltrials.eu [5]. The Netherlands Heart Institute was attracted as an independent party responsible for hosting and reviewing submitted protocols and the University Medical Center Utrecht (UMCU) formed the legal entity. An advisory board was established to advise the steering committee regarding, e.g., the future direction and implementation strategy of the registry. Discussions with several researchers and members of animal welfare bodies helped to optimise the registration form and identify concerns about preregistration. Common concerns were (1) administrative burden and additional costs; (2) limited flexibility of creativity; (3) misuse by animal activists; and (4) the fear of data theft/threats to intellectual property. Firstly, we aimed to determine the minimal amount of detail required to have an impact on research rigour, thereby minimising the additional administrative burden for researchers. We simultaneously set out to further reduce the administrative burden by enabling an automatic transfer of the required information from local digital systems to the preclinicaltrials.eu format. Within the UMCU, researchers will be able to copy most of the required information from their local application form to preclinicaltrials.eu with the click of a button. Once published, protocols can be amended, but all previous versions remain accessible. Regarding privacy, personal details of the researchers are anonymised, except for the institution where the experiments are performed. It is possible to contact the submitting researcher through an encrypted email message to facilitate collaboration. Detailed information of protocols can only be accessed after creating an account and logging in. Without an account, only the title and study centre details of protocols are visible. Regarding the fear of sharing preliminary ideas, preclinicaltrials.eu provides the option to register a protocol under embargo. The full details of the protocol remain hidden until revealed by the investigator or after a release date, which is automatically set at 1 year after registration. Even though these concessions delay our aim to create full transparency, we feel that the benefits of preregistration outweigh this downside. Also, we propose that these solutions are necessary at this stage, until preregistration becomes the gold standard and the research community comes to view preregistration as a safeguard against intellectual theft of scientific ideas and intellectual property (since preregistration in fact “claims” an idea), rather than a risk.

The future of preclinical preregistration We believe it is time for the scientific community to take responsibility and move towards more effective animal research. We encourage funders to guard quality in research by making preregistration mandatory and journals to make preregistration a requirement for publication, akin to the standard for clinical trials. Approval committees and institutions involved in animal research should require accountability of previously provided animals as part of a new application, and funders could do the same for new funding applications. Institutes can incorporate preregistration in their reward system, and journals can reward researchers who preregister; we support the preregistration badges and Registered Report format already provided by several journals [12]. Compliance can be monitored by journals in the review process. In the end, the most important stakeholder is the researcher, who can start to preregister right away. We aim to promote preregistration among researchers to increase awareness. To ease preregistration, we are focusing on minimising the administrative burden for researchers and offer online guidance and workshops.

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[1] Url: https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.3001397

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