BOX 5-2
Summary of Session Points

3Rs

•   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

•   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.



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