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Protocol for a systematic review of guidelines for rigour in the design, conduct and analysis of biomedical experiments involving laboratory animals

Abstract

Objective Within the last years, there has been growing awareness of the negative repercussions of unstandardized planning, conduct and reporting of preclinical and biomedical research. Several initiatives have set the aim of increasing validity and reliability in reporting of studies and publications, and publishers have formed similar groups. Additionally, several groups of experts across the biomedical spectrum have published experience and opinion-based guidelines and guidance on potential standardized reporting. While all these guidelines cover reporting of experiments, an important step prior to this should be rigours planning and conduction of studies. The aim of this systematic review is to identify and harmonize existing experimental design, conduct and analysis guidelines relating to internal validity and reproducibility of preclinical animal research. The review will also identify literature describing risks of bias pertaining to the design, conduct and analysis of preclinical biomedical research.

Search strategy PubMed, Embase and Web of Science will be searched systematically to identify guidelines published in English language in peer-reviewed journals before January 2018 (box 1). All articles or systematic reviews in English language that describe or review guidelines on the internal validity and reproducibility of animal studies will be included. Google search for guidelines published on the websites of major funders and professional organisations can be found in (Box 2).

Screening and annotation Unique references will be screened in two phases: screening for eligibility based on title and abstract, followed by screening for definitive inclusion based on full text. Screening will be performed in SyRF (http://syrf.org.uk). Each reference will be randomly presented to two independent reviewers. Disagreements between reviewers will be resolved by additional screening of the reference by a third, senior researcher.

Data management and reporting All data, including extracted text and guidelines, will be stored in the SyRF platform. Elements of the included guidelines will be identified using a standardized extraction form. Reporting will follow the PRISMA guidelines as far as applicable.

  • BMJOS
  • drug evaluation, preclinical
  • protocols & guidelines

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Footnotes

  • Data availability statement All data relevant to the study are included in the article.

  • Contributor JV drafted this protocol, all authors commented, corrected and agreed on the final version. All authors took part in the planning and design of this study.

  • Funding This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777364. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned, externally peer reviewed.

  • Collaborators The EQIPD WP3 study group members are: Judi Clark, Emily Sena, Bruno Boulanger, Gernot Riedel, Bettina Platt, Annesha Sil, Martien J Kas, Bernhard Voelkl, Mathias Jucker, Bettina M Wegenast-Braun, René Bernard, Esmeralda Heiden, Ann-Marie Waldron, Maarten Loos, Merel Ritskes-Hoitinga, Tom Van De Casteele, Pim Drinkenburg, Juan Diego Pita Almenar, David Gallacher, Henk Van Der Linde, Anja Gilis, Greet Teuns, Karsten Wicke, Sabine Grote, Bernd Sommer, Janet Nicholson, Sanna Janhunen, Sami Virtanen, Kristin Cheng, Sylvie Ramboz, Emer Leahy, Isabel A Lefevre, Fiona Ducrey, Javier Guillen, Patri Vergara, Thomas Ingraham.

  • Open material Supplied.

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