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Promoting transparency in preclinical research: preregistration of animal study protocols on www.preclinicaltrials.eu

Smit NW1, Van der Naald M2,3, Wever KE4, Duncker DJ1,5, Chamuleau SAJ2,3,6  

1Netherlands Heart Institute, The Netherlands 
2University Medical Center Utrecht, The Netherlands 
3Member of the Transnational AllianCe for regenerative Therapies In Cardiovascular Syndromes 
4SYRCLE, Department for Health Evidence, Radboud university medical center, Nijmegen, The Netherlands 
5Erasmus Medical Center, The Netherlands 
6Nucleus member of the CARE working group of the ESC

Researchers fromthe University Medical Center Utrecht and the Radboud university medical center in Nijmegenhave developed an online registry tailored and dedicated specifically to the registration of animal study protocols: www.preclinicaltrials.eu. Preclinicaltrials.eu is presently funded and managed by the Netherlands Heart Institute. 

Animal research is pivotal for the discovery of novel therapies, but translation from the preclinical to the clinical setting has been limited.We believe that prospective registration of animal study protocols is essential to reduce waste in preclinical research and increase its value for patients. Preclinicaltrials.eu aims to provide a unique, permanent, comprehensive listing of animal study protocols, including studies that may remain unpublished. Researchers can anonymously (pre)register their protocols of animal studies free of charge, with an optional embargo period. Ourregistry promotes transparency in animal research, by allowing researchers to prospectively record key aspects of their study methodology, make amendments when needed, and link to the resulting data (published or unpublished). This will help to avoid unnecessary duplication of studies and reduce publication bias. Furthermore, preclinicaltrials.eu aims to increase awareness of the importance of internal study validity and measures to reduce bias, such as randomization and blinding. 

The registration form was designed by an international expert group on animal studies and preclinical evidence synthesis, based on current gold standard guidance on reporting and conduct of animal experiments. It was specifically designed to capture the distinctive details of animal studies relevant to their reproducibility and robustness, such as details on the study‚Äôs hypothesis, design, primary and secondary outcome measures, measures to reduce bias, and the sample size rationale. Another unique feature of the register is that it allows researchers to search specific fields of the registered records to find comparable studies (preferably prior to conducting their own), either to avoid unnecessary replication, or to optimize their protocol.

Preclinicaltrials.euis supported by the Dutch Heart Foundation, one of the largest funders of scientific research in the Netherlands, and by several scientific societies (e.g. the Transnational AllianCe for regenerative Therapies In Cardiovascular Syndromes (TACTICS), the SYstematic Review Center for Laboratory animal Experimentation (SYRCLE) and the Partnership for Assessment and Accreditation of Scientific Practice (PAASP). Discussionswith other funding agencies, institutes and journals are ongoing and we hope to add their support soon. The scientific advisory board of preclinicaltrials.eu consists of 6 members (Prof. John Ioannidis, health research and policy; Prof. Jonathan Kimmelman, biomedical ethics; Prof. Paul Glasziou, evidence-based practice/medicine; Prof. Annelien Bredenoord, ethics of biomedical innovations and politician; Prof. Lina Badimon, scientific affairs; and Prof. Thomas Eschenhagen, experimental pharmacology and toxicology and cardiovascular research) who provide support and counsel to the steering committee on the future development of the registry.In July 2018, the Dutch House of Representatives passed a motion stating that prospective registration of animal studies and sharing of data should become the norm.

We believe all stakeholders involved in (animal) research should encourage preregistration. We call upon researchers, scientific societies/institutes, medical journals, funding bodies, policy and law makers, and others involved parties to make prospective registration a standard requirement for animal studies. For more information, or if you would like to support this initiative, please visit www.preclinicaltrials.euor contact info@preclinicaltrials.eu.

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