Animal research

Pre-registration of animal research protocols: development and overview over 3 years from preclinicaltrials.eu

This article was originally published here

BMJ Open Sci. 2022 Mar 16;6(1):e100259. doi: 10.1136/bmjos-2021-100259. eCollection 2022.

ABSTRACT

Open and prospective registration of a study protocol can improve research rigor in several ways. With pre-registration, key features of the study methodology are recorded and maintained as a permanent record, allowing the completed study to be compared with what was planned. By recording the study hypothesis and the a priori predicted results, pre-registration creates transparency and can reduce the risk of several common biases, such as hypothesizing after the results are known and changing the result or selective communication of results. Second, pre-registration raises awareness of measures to reduce bias, such as randomization and blinding. Third, pre-registration provides a complete list of planned studies, which can avoid unnecessary duplication and reduce publication bias. Although commonly recognized and applied in clinical research since 2000, pre-registration of animal studies is not yet the norm. In 2018, we launched the first open online registry dedicated to animal study protocols: wwwpreclinicaltrialseu. Here we provide an overview of the development of preclinicaltrials.eu (PCT) and assess its use in the first 3 years after launch. In addition, we elaborate on ongoing developments such as the rise of comparable registers, increased support for pre-registration in the Netherlands – which led to PCT funding from the Dutch government – ​​and pilot projects mandatory pre-registration by several funding agencies. We show the international coverage of currently registered protocols, but with the overall low number of (pre)registered protocols.

PMID:35372701 | PMC: PMC8928250 | DOI:10.1136/bmjos-2021-100259