Most new medicines are assessed for their potential to affect the cardiovascular system before first-in-human clinical trials. These studies are usually carried out in dogs or non-human primates and are designed to better understand the potential of drugs to affect parameters including blood pressure, heart rate and ECG. This is commonly performed during either a standalone safety pharmacology study (with the animals implanted with a telemetry device) or as part of the repeat dose toxicology study (using recordings obtained from animals wearing jackets containing the recording equipment).
Due to limitations with the telemetry devices used, study design or concerns about damage to the equipment (e.g. jackets) the animals are often individually housed during the recording periods and this separation may introduce additional stress to the animals.
Together with the Safety Pharmacology Society we established a working group with 14 pharmaceutical companies and contract research organisations to better understand company approaches to these studies and the opportunities and barriers for adopting best practice in social housing. Data was collected via a survey and a workshop was held at the Safety Pharmacology Society 15th annual meeting in Prague on 1 October 2015. Recommendations were published in 2016 (see Prior et al 2016).
In order to track the implementation of social-housing during recordings since the workshop and publication, data was collected in a further survey in 2017, with results presented as a poster at the Safety Pharmacology Society 17th annual meeting in Berlin in September 2017 (see Prior et al., 2017).
Papers and posters from the working group
Why are non-rodents not socially housed during cardiovascular telemetry recordings on safety pharmacology studies? presented at SPS, September 2017, and the NC3Rs Cardiovascular Showcase, March 2018.
Prior H, Bottomley A, Champéroux P, Cordes J, Delpy E, Dybdal N, Edmunds N, Engwall M, Foley M, Hoffmann M, Kaiser R, Meecham K, Milano S, Milne A, Nelson R, Roche B, Valentin JP, Ward G, Chapman K (2016). Social housing of non-rodents during cardiovascular recordings in safety pharmacology and toxicology studies. Journal of Pharmacological and Toxicological Methods 81: 75-87 doi:10.1016/j.vascn.2016.03.004
Global cross-company data-sharing on the housing of non-rodents during the recording of cardiovascular telemetry data on safety pharmacology and toxicology studies - safety pharmacology studies presented at SPS September 2015
Global cross-company data-sharing on the housing of non-rodents during the recording of cardiovascular telemetry data on safety pharmacology and toxicology studies - toxicology studies presented at EuroTox September 2015
We have also collated papers and posters related to telemetry recording in both safety pharmacology and toxicology studies. These can be downloaded below.
Dog safety pharmacology (implanted telemetry)
Pair-housed dog telemetry: Animal welfare refinement with early indications of similar study sensitivity presented at SPS October 2014
A comparison of baseline heart rates, left ventricular and systolic pressures in group versus single housed dogs and the effects of housing on sensitivity to detect changes in contractility following pimobendan administration presented at SPS September 2015
Comparative analysis of data sciences international PhysioTel™ D70 and PhysioTel™ digital telemetry platforms presented at SPS September 2015
Markert M, Trautmann T, Krause F, Cioaga M, Mouriot S, Wetzel M and Guth B (2018). A new telemetry-based system for assessing cardiovascular function in group-housed large animals. Taking the 3Rs to a new level with the evaluation of remote measurements via cloud data transmission. Journal of Pharmacological and Toxicological Methods (in press) doi:10.1016/j.vascn.2018.03.006
Sadekova N, Boudreau G, Jalbert B and Norton K (2016). The effects of housing conditions on baseline cardiovascular parameters and the sensitivity to detect changes in contractility in telemetry-implanted dogs. Journal of Pharmacological and Toxicological Methods 81: 60-74 doi:10.1016/j.vascn.2016.05.001
Klumpp A, Trautmann T, Markert M and Guth B (2006). Optimising the experimental environment for dog telemetry studies. Journal of Pharmacological and Toxicological Methods 54: 141-149 doi:10.1016/j.vascn.2006.03.010
Markert M, Klumpp A, Trautmann T, Mayer K, Stubhan M and Guth B (2007). The value added by measuring myocardial contractility in vivo in safety pharmacological profiling of drug candidates. Journal of Pharmacological and Toxicological Methods 56: 203-211 doi:10.1016/j.vascn.2007.03.004
NHP safety pharmacology (implanted telemetry)
Andersen N, Meyer O, Bradley A, Dragsted N, Lassen A, Sjogren I, Larsen J, Harvey W, Bator R and Milne A (2017). Evaluation of the PhysioTel Digital M11 cardiovascular telemetry implant in socially housed cynomolgus monkeys up to 16 weeks after surgery. Journal of Pharmacological and Toxicological Methods 87: 82-92 doi:10.1016/j.vascn.2017.04.007
Evaluation of digital implantable telemetry in multiple social housing paradigms for cynomolgus monkey presented at SPS September 2015
Assessment of drug-induced cardiovascular effects by telemetry in group-housed cynomolgus monkeys presented at SPS September 2013
Minipig safety pharmacology (implanted telemetry)
Stubhan M, Markert M, Mayer K, Trautmann T, Klumpp A, Henke J and Guth B (2008). Evaluation of cardiovascular and ECG parameters in the normal, freely moving Gottingen minipig. Journal of Pharmacological and Toxicological Methods 57: 202-211 doi:10.1016/j.vascn.2008.02.001
Dog toxicology (JET)
Non-invasive telemetry for monitoring ECG in singly and group housed dogs – the effect of Moxifloxacin presented at SPS October 2008
NHP Toxicology (JET-BP)
JET-BP in socially housed nonhuman primates: comparison of Covance sites and study considerations presented at SOT March 2015
Xing G, Lu J, Hu M, Wang S, Zhao L, Zheng W, Schofield J, Oldman K, Adkins D, Yu H, Platz S and Skinner M (2015). Effects of group housing on ECG assessment in conscious cynomolgus monkeys. Journal of Pharmacological and Toxicological Methods 75: 44-51 doi:10.1016/j.vascn.2015.05.004
Kaiser R, Tichenor S, Regalia D, York K and Holzgrefe H (2015). Telemetric assessment of social and single housing: Evaluation of electrocardiographic intervals in jacketed cynomolgus monkeys. Journal of Pharmacological and Toxicological Methods 75: 38-43 doi:10.1016/j.vascn.2015.05.001
Posters from the NC3Rs Cardiovascular Showcase breakout session (March 2018)
Bjarkadóttir AV, Bjarnason A and Gunnarsson A (2018). Leadless heart rate loggers minimize impact of surgery and allow social-housing.
Haas T, Johnson D and Martin S (2018). Advances in physiologic telemetric monitoring compatible with social housing.
Prior H, Gellatly N and Jackson S (2018). Why are non-rodents not socially housed during cardiovascular telemetry recordings on safety pharmacology studies?
Schifrin S, Lee D and Knot H (2018). A novel freely moving animal-based blood pressure, ECG, and dual body temperature telemetry system for group housed mice in social context.
Skinner M, White P and Ceuppens P (2018). Double-decker rodent telemetry – a ‘stretch’ objective.