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Automated Monitoring / Animal Studies Modernization - Physiology Working Group

Problem Statement

There are physiologic endpoints that are routinely measured in clinical trials that are not routinely collected in animal studies.  These endpoints may provide a clearer and broader line of sight from animal studies to human patients.  These endpoints may also provide more sensitive and quantitative measures of animal health enabling earlier termination decisions that avoid undue pain and distress. Novel advances in vivarium technology could enable routine and efficient collection of these endpoints, and provide the ability to iteratively learn from our studies in perpetuity, to assess disease states and safety more objectively and with quantitative measures and evidence-based animal wellbeing and husbandry.

 

Mission and Objectives

This working group will identify a discrete list of routine physiologic endpoints (e.g. body temperature, body weight, heart rate, respiratory rate, etc.) that may add value in animal studies conducted to evaluate the effectiveness or safety of novel therapeutics and assess disease states.  It will define specific contexts of use (e.g. what studies in which to measure), conditional parameters (e.g. continuous vs. non-continuous monitoring/measures), supporting evidence for their value and available technologic solutions. 

The aim of this effort would be to enhance reproducibility and the translational relevance of animal studies ensuring their scientific impact and decreasing clinical attrition related to translational discordance.  Another primary aim is to optimize endpoints and our ability to detect pain and distress in animals enhancing care and welfare practices. 

 

Deliverables

Manuscript(s), technology assessment, white paper(s), welfare recommendations