Strategies to encourage the adoption of social housing during cardiovascular telemetry recordings in non-rodents.

The National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) is working with industry to promote social housing during cardiovascular telemetry recordings within non-rodent safety pharmacology and toxicology studies. Following surveys to capture current practice, benefits and concerns to adoption of this refinement (2015 and 2017), a 2018 European workshop shared experience and practical advice to address common barriers such as sensitivity of different study designs and the potential for cross-contamination with test article in socially-housed conditions. A similar number of responses were received to each survey (38 in 2015; 36 in 2017), from biopharmaceutical companies and CROs that perform or outsource non-rodent telemetry studies. Each dataset had different respondents, but 19 facilities provided answers regarding dogs and non-human primates (NHPs) for both surveys. More respondents socially-housed their non-rodents in 2017; increases were apparent for both the non-recording/acclimatisation periods and the telemetry recording periods compared with 2015. However, on recording days only 60, 75 and 89% of respondents from Europe and 25, 14 and 36% of respondents from outside of Europe socially-housed their dogs, minipigs or NHPs respectively. The potential for contamination with test article between animals housed together is considered by some facilities as justification for individual housing during recordings, however, survey data did not support this rationale. Nine organisations provided data on prevalence of vomiting during telemetry studies, showing the risk was moderate for dogs and very low for minipig and NHP. Further, if vomiting did occur, this could be managed effectively with little impact on study outcomes or validity and with careful dose selection, the risk is further diminished. A recent increase in published papers and posters on this topic would suggest many more companies are planning, or have recently implemented, this refinement. The continued willingness of the community to share practical experience and publish validation data may lead to this approach becoming the 'new standard' across the industry in the near future, representing a core component of 'best-practice' recommendations to increase animal welfare whilst maintaining quality data provision for investigational and regulatory purposes.