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

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, Van Der Naald, Mira, Chamuleau, Steven A.J., Menon, Julia M.L., De Leeuw, Wim, De Haan, Judith, Duncker, Dirk J., and Wever, Kimberley Elaine

Abstract

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.

Published
2022

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

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, Van Der Naald, Mira, Chamuleau, Steven A.J., Menon, Julia M.L., De Leeuw, Wim, De Haan, Judith, Duncker, Dirk J., and Wever, Kimberley Elaine

Abstract

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.

Published
2022

8. Publication rate in preclinical research

Author

van der Naald, Mira, Wenker, Steven, Doevendans, Pieter A, Wever, Kimberley E, Chamuleau, Steven A J, Cardiology, ACS - Atherosclerosis & ischemic syndromes, and ACS - Heart failure & arrhythmias

Subjects
preclinicaltrials.eu, publication rate, publication bias, translational research, preregistration, lcsh:R, lcsh:Medicine, Original Research
Abstract

Objectives The ultimate goal of biomedical research is the development of new treatment options for patients. Animal models are used if questions cannot be addressed otherwise. Currently, it is widely believed that a large fraction of performed studies are never published, but there are no data that directly address this question. Methods We have tracked a selection of animal study protocols approved in the University Medical Center Utrecht in the Netherlands, to assess whether these have led to a publication with a follow-up period of 7 years. Results We found that 60% of all animal study protocols led to at least one publication (full text or abstract). A total of 5590 animals were used in these studies, of which 26% was reported in the resulting publications. Conclusions The data presented here underline the need for preclinical preregistration, in view of the risk of reporting and publication bias in preclinical research. We plea that all animal study protocols should be prospectively registered on an online, accessible platform to increase transparency and data sharing. To facilitate this, we have developed a platform dedicated to animal study protocol registration: www.preclinicaltrials.eu.

Published
2020
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9. A 3-year evaluation of preclinicaltrials.eu reveals room for improvement in preregistration of animal studies

Author

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

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.

Published
2021

10. The FAIR Funder pilot programme to make it easy for funders to require and for grantees to produce FAIR Data

Author

Wittenburg, Peter, Sustkova, Hana Pergl, Montesanti, Annalisa, Bloemers, Margreet, de Waard, S.H., Musen, Mark A., Graybeal, John, Hettne, Kristina M., Jacobsen, Annika, Pergl, Robert, Hooft, Rob W.W., Staiger, Christine, van Gelder, Celia W.G., Knijnenburg, Sebastiaan L., van Arkel, A.C., Meerman, Bert, Wilkinson, Mark D., Sansone, S.A., Rocca-Serra, Philippe, McQuilton, Peter, Gonzalez-Beltran, Alejandra N., Aben, G.J.C., Henning, P., de Menezes Alencar, Maria Simone, Ribeiro, C., Silva, C.R.L., Sayao, Luis, Sales, Luana, Veiga, Viviane, Lima, Jefferson, Dib, Simone, Xavier dos Santos, Paula, Murtinho, R., Tendel, Jakob, Schaap, B.F., Brouwer, P.M., Gavai, A.K., Bouzembrak, Yamine, Marvin, Hans J.P., Mons, Albert, Kuhn, Tobias, Gambardella, A.A., de Miranda Azevedo, Ricardo, Muhonen, Vesa, van der Naald, Mira, Smit, N.W., Buys, M.J., de Bruin, Taco F., Schoots, Fieke, Goodson, H.J.E., Rzepa, Henry S., Jeffery, Keith G., Shanahan, Hugh P., Axton, M., Tkachenko, Veniamin, Deslattes Maya, Anne, Meyers, Natalie, Conlon, Michael, Haak, Laurel L., and Schultes, Erik

Subjects
Plant Breeding, Laboratorium voor Plantenveredeling, BU Toxicologie, Novel Foods & Agroketens, Land Use and Food Security, Life Science, Landgebruik en Voedselzekerheid, BU Toxicology, Novel Foods & Agrochains
Abstract

There is a growing acknowledgement in the scientific community of the importance of making experimental data machine findable, accessible, interoperable, and reusable (FAIR). Recognizing that high quality metadata are essential to make datasets FAIR, members of the GO FAIR Initiative and the Research Data Alliance (RDA) have initiated a series of workshops to encourage the creation of Metadata for Machines (M4M), enabling any self-identified stakeholder to define and promote the reuse of standardized, comprehensive machine-actionable metadata. The funders of scientific research recognize that they have an important role to play in ensuring that experimental results are FAIR, and that high quality metadata and careful planning for FAIR data stewardship are central to these goals. We describe the outcome of a recent M4M workshop that has led to a pilot programme involving two national science funders, the Health Research Board of Ireland (HRB) and the Netherlands Organisation for Health Research and Development (ZonMW). These funding organizations will explore new technologies to define at the time that a request for proposals is issued the minimal set of machine-actionable metadata that they would like investigators to use to annotate their datasets, to enable investigators to create such metadata to help make their data FAIR, and to develop data-stewardship plans that ensure that experimental data will be managed appropriately abiding by the FAIR principles. The FAIR Funders design envisions a data-management workflow having seven essential stages, where solution providers are openly invited to participate. The initial pilot programme will launch using existing computer-based tools of those who attended the M4M Workshop.

Published
2019

11. Validation of a novel stand-alone software tool for image guided cardiac catheter therapy

Author

van Es, René, van den Broek, Hans T, van der Naald, Mira, de Jong, Leon, Nieuwenhuis, Eliane R, Kraaijeveld, Adriaan O, Doevendans, Pieter A, Chamuleau, Steven A J, van Slochteren, Frebus J, van Es, René, van den Broek, Hans T, van der Naald, Mira, de Jong, Leon, Nieuwenhuis, Eliane R, Kraaijeveld, Adriaan O, Doevendans, Pieter A, Chamuleau, Steven A J, and van Slochteren, Frebus J

Published
2019

13. Validation of a novel stand-alone software tool for image guided cardiac catheter therapy

Author

Team Onderzoek, Onderzoek Algemene Cardiologie, Team Medisch, Regenerative Medicine and Stem Cells, Circulatory Health, Cardiologie, van Es, René, van den Broek, Hans T, van der Naald, Mira, de Jong, Leon, Nieuwenhuis, Eliane R, Kraaijeveld, Adriaan O, Doevendans, Pieter A, Chamuleau, Steven A J, van Slochteren, Frebus J, Team Onderzoek, Onderzoek Algemene Cardiologie, Team Medisch, Regenerative Medicine and Stem Cells, Circulatory Health, Cardiologie, van Es, René, van den Broek, Hans T, van der Naald, Mira, de Jong, Leon, Nieuwenhuis, Eliane R, Kraaijeveld, Adriaan O, Doevendans, Pieter A, Chamuleau, Steven A J, and van Slochteren, Frebus J

Published
2019

14. Fracture of the Sesamoid Bone of the Thumb: A Case Report and Review of the Literature

Author

UMC Utrecht, Onderzoek Algemene Cardiologie, Zorgeenheid Plastische Chirurgie Medisch, Other research (not in main researchprogram), Van Der Naald, Mira, Van Der Naald, Niels, Van Der Velde, Detlef, Schuurman, Arnold H., UMC Utrecht, Onderzoek Algemene Cardiologie, Zorgeenheid Plastische Chirurgie Medisch, Other research (not in main researchprogram), Van Der Naald, Mira, Van Der Naald, Niels, Van Der Velde, Detlef, and Schuurman, Arnold H.

Published
2019

15. Lower retention after retrograde coronary venous infusion compared with intracoronary infusion of mesenchymal stromal cells in the infarcted porcine myocardium

Author

Onderzoek Vrouw Hart & Vaatziekten, Onderzoek Algemene Cardiologie, Team Onderzoek, Team Medisch, Circulatory Health, Onderzoek Cardiovasculair Reg. Med., Regenerative Medicine and Stem Cells, Cardiologie, Gathier, Wouter A., Van Der Naald, Mira, Van Klarenbosch, Bas R., Tuinenburg, Anton E., Bemelmans, John L.M., Neef, Klaus, Sluijter, Joost P.G., Van Slochteren, Frebus J., Doevendans, Pieter A., Chamuleau, Steven A.J., Onderzoek Vrouw Hart & Vaatziekten, Onderzoek Algemene Cardiologie, Team Onderzoek, Team Medisch, Circulatory Health, Onderzoek Cardiovasculair Reg. Med., Regenerative Medicine and Stem Cells, Cardiologie, Gathier, Wouter A., Van Der Naald, Mira, Van Klarenbosch, Bas R., Tuinenburg, Anton E., Bemelmans, John L.M., Neef, Klaus, Sluijter, Joost P.G., Van Slochteren, Frebus J., Doevendans, Pieter A., and Chamuleau, Steven A.J.

Published
2019

16. Lower retention after retrograde coronary venous infusion compared with intracoronary infusion of mesenchymal stromal cells in the infarcted porcine myocardium

Author

Gathier, Wouter A, primary, van der Naald, Mira, additional, van Klarenbosch, Bas R, additional, Tuinenburg, Anton E, additional, Bemelmans, John LM, additional, Neef, Klaus, additional, Sluijter, Joost PG, additional, van Slochteren, Frebus J, additional, Doevendans, Pieter A, additional, and Chamuleau, Steven AJ, additional

Published
2019
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17. Translational Research in Cardiovascular Repair : A Call for a Paradigm Shift

Author

Chamuleau, Steven A J, van der Naald, Mira, Climent, Andreu M., Kraaijeveld, Adriaan O, Wever, Kim E, Duncker, Dirk J, Fernández-Avilés, Francisco, Bolli, Roberto, Transnational Alliance for Regenerative Therapies in Cardiovascular Syndromes (TACTICS) Group, Chamuleau, Steven A J, van der Naald, Mira, Climent, Andreu M., Kraaijeveld, Adriaan O, Wever, Kim E, Duncker, Dirk J, Fernández-Avilés, Francisco, Bolli, Roberto, and Transnational Alliance for Regenerative Therapies in Cardiovascular Syndromes (TACTICS) Group

Published
2018

19. Retrograde Coronary Venous Infusion as a Delivery Strategy in Regenerative Cardiac Therapy: an Overview of Preclinical and Clinical Data

Author

Cardiovasculaire Immunologie, Onderzoek Algemene Cardiologie, Circulatory Health, Regenerative Medicine and Stem Cells, Gathier, Wouter A., van Ginkel, Dirk Jan, van der Naald, Mira, van Slochteren, Frebus J., Doevendans, Pieter A., Chamuleau, Steven A.J., Cardiovasculaire Immunologie, Onderzoek Algemene Cardiologie, Circulatory Health, Regenerative Medicine and Stem Cells, Gathier, Wouter A., van Ginkel, Dirk Jan, van der Naald, Mira, van Slochteren, Frebus J., Doevendans, Pieter A., and Chamuleau, Steven A.J.

Published
2018

20. Translational Research in Cardiovascular Repair: A Call for a Paradigm Shift

Author

Cardiologie, Team Medisch, Circulatory Health, Regenerative Medicine and Stem Cells, Onderzoek Algemene Cardiologie, Chamuleau, Steven A J, van der Naald, Mira, Climent, Andreu M., Kraaijeveld, Adriaan O, Wever, Kim E, Duncker, Dirk J, Fernández-Avilés, Francisco, Bolli, Roberto, Transnational Alliance for Regenerative Therapies in Cardiovascular Syndromes (TACTICS) Group, Cardiologie, Team Medisch, Circulatory Health, Regenerative Medicine and Stem Cells, Onderzoek Algemene Cardiologie, Chamuleau, Steven A J, van der Naald, Mira, Climent, Andreu M., Kraaijeveld, Adriaan O, Wever, Kim E, Duncker, Dirk J, Fernández-Avilés, Francisco, Bolli, Roberto, and Transnational Alliance for Regenerative Therapies in Cardiovascular Syndromes (TACTICS) Group

Published
2018

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