General Principles of Preclinical Study Design

Wenlong Huang*, Nathalie Percie du Sert, Jan Vollert, Andrew S C Rice

*Corresponding author for this work

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Abstract

Preclinical studies using animals to study the potential of a therapeutic drug or strategy are important steps before translation to clinical trials. However, evidence has shown that poor quality in the design and conduct of these studies has not only impeded clinical translation but also led to significant waste of valuable research resources. It is clear that experimental biases are related to the poor quality seen with preclinical studies. In this chapter, we will focus on hypothesis testing type of preclinical studies and explain general concepts and principles in relation to the design of in vivo experiments, provide definitions of experimental biases and how to avoid them, and discuss major sources contributing to experimental biases and how to mitigate these sources. We will also explore the differences between confirmatory and exploratory studies, and discuss available guidelines on preclinical studies and how to use them. This chapter, together with relevant information in other chapters in the handbook, provides a powerful tool to enhance scientific rigour for preclinical studies without restricting creativity.
Original languageEnglish
Title of host publicationHandbook of Experimental Pharmacology
Place of PublicationBerlin
PublisherSpringer
Pages1-15
Number of pages15
DOIs
Publication statusE-pub ahead of print - 10 Nov 2019

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Keywords

  • experimental bias
  • hypothesis generating
  • hypothesis testing
  • in vivo studies
  • preclinical research

Cite this

Huang, W., du Sert, N. P., Vollert, J., & Rice, A. S. C. (2019). General Principles of Preclinical Study Design. In Handbook of Experimental Pharmacology (pp. 1-15). Springer . https://doi.org/10.1007/164_2019_277