Summary of Session Points
• Advances in technology have and will continue to provide opportunities for replacement, refinement, and reduction (3Rs).
• Increased understanding of disease mechanism may help in development of replacement and refinement strategies.
• Replacement: In vitro cell culture models can be used to test reagents and potential therapeutic candidates, including prescreening combinations of bio-logical and pharmacological agents.
• Refinement: Simple refinements can improve study results while positively impacting concerns about animal care and use.
• Reduction is often a “by-product” of refinement.
• Systematic reviews of preclinical data could potentially:
o Improve the quality and value of animal studies and support the 3Rs.
o Better inform the timing, design, and benefit of clinical trials.
• The path to implementation of systematic reviews of preclinical data might in- the Food and Drug Administration, pharmaceutical companies, research institutions, and publishers.
SOURCE: Individual panelists and participants.