Improving Translation by Identifying Evidence for More Human-Relevant Preclinical Strategies

Animals, vol. 10, pp. 1170

Abstract

Preclinical animal studies are performed to analyse the safety and efficacy of new treatments, with the aim to protect humans. However, there are questions and concerns about the quality and usefulness of preclinical animal research. Translational success rates vary between 0 and 100%, and no clear relationship has been found with possible predictive factors such as animal species or field of research. Therefore, it is not yet possible to indicate what factors predict successful translation. Translational strategies were therefore discussed at an international conference held in the Netherlands in November 2019, aiming to develop practical guidelines for more robust animal-to-human translation. The conference was organised during the course of a research project funded by the Dutch Research Council (313-99-310), addressing possible solutions for the low translational values that had been published for a multitude of animal studies in human health care. This article provides an overview of the project and the conference discussions. Based on the conference results and the findings from the research project, we define four points of attention that are crucial in the search for improved translational success rates: (a) optimising the methods and design of studies; (b) incorporation of the complexity of the human patient in research; (c) start with the patient rather than existing animal models as the gold standard; and (d) more and better collaboration within the chain from funding to pharmacy. We conclude that this requires improved organization and use of procedures, as well as a change of attitude and culture in research, including a consideration of the translational value of animal-free innovations and human-relevant science.

Authors 6

1. Merel Ritskes‐Hoitinga corresponding

   Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Health Sciences

   Affiliation as printed

   SYRCLE, Department for Health Evidence (section HTA), Radboud Institute for Health Sciences, Radboud University Medical Centre, 6500 HB Nijmegen, The Netherlands

2. Cathalijn H. C. Leenaars

   Utrecht University · Medizinische Hochschule Hannover

   Affiliation as printed

   Institute for Laboratory Animal Science, Hannover Medical School, 30625 Hannover, Germany

   Unit Animals in Science and Society, Department of Population Health Sciences, Faculty of Veterinary Medicine, Utrecht University, 3508 TD Utrecht, The Netherlands

3. Wouter Beumer Aachen ProQR Therapeutics NV

   ProQR Therapeutics (Netherlands)

   Affiliation as printed

   ProQR Therapeutics NV, 2333 CK Leiden, The Netherlands

4. Tineke Coenen-de Roo Aachen Central Animal Facility

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Central Animal Facility, Leiden University Medical Centre, 2300 RC Leiden, The Netherlands

5. Frans R. Stafleu

   Utrecht University

   Affiliation as printed

   Ethics Institute, Faculty of Humanities, Utrecht University, 3508 TC Utrecht, The Netherlands

6. Franck L. B. Meijboom

   Utrecht University

   Affiliation as printed

   Ethics Institute, Faculty of Humanities, Utrecht University, 3508 TC Utrecht, The Netherlands

   Unit Animals in Science and Society, Department of Population Health Sciences, Faculty of Veterinary Medicine, Utrecht University, 3508 TD Utrecht, The Netherlands