Avoiding Common Pitfalls in Preclinical Animal Research Design

The symposium “Avoiding Common Pitfalls in Preclinical Animal Research Design” was part of EB 2018, hosted by the Animal Care and Experimentation Committee, Chaired by Daniel Michele and Co-Chaired by Karen Uray.

Abstract

The topic of preclinical animal research experimental design has become increasingly important due to concerns about ensuring that the findings of such studies are both reproducible and relevant to human medicine. This symposium is intended to provide useful information both for those contemplating their first animal studies as well as those interested in satisfying preclinical data requirements for new drug targets. Participants will acquire a broad sense of what factors to consider in designing rigorous preclinical animal studies. Three aspects of experimental design considerations will be addressed. The first aspect is selecting an appropriate animal model and will address factors such as species, age, genetic background, and pathogen status. It will also include induced vs. naturally-occurring diseases and the role of large animal models. The second topic is satisfying FDA requirements for preclinical data and will include study design and species selection to inform and design appropriate and safe First-In-Human trials. The third topic is biological variables to consider in writing an NIH grant.

Speakers

• Selecting the appropriate animal model in preclinical research. (starts 2:02)
  James Fox — Division of Comparative Medicine, Massachusetts Institute of Technology
• Translational preclinical research: What the FDA wants to know. (starts 36:10)
  Valerie Hamilton — Veterinary Pathology, Merck Sharp and Dohme Corpe
• Addressing appropriate biological variables in NIH grant applications. (starts 1:10:52)
  Tom Cheever — Division of Musculoskeletal Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases