Refinement of rodent and non-rodent housing during telemetry recordings

Telemetry is a method which allows the remote measurement of physiological parameters from animals in their home environment without disturbance. Telemetered rodents (guinea-pigs, rats and mice) are often used within research models or early drug screening. Non-rodents (dogs, mini-pigs or non-human primates) are required for cardiovascular safety studies of potential new medicines before human clinical trials, 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, or from implanted telemetry devices).

During these studies, animals were often individually-housed due to cross-talk between signals. However, in the last decade, developments in telemetry technologies has allowed recordings from animals housed in compatible pairs or groups (social housing). The NC3Rs has worked with the pharmaceutical industry to promote adoption of this refinement, conducting surveys in 2015 and 2017 to better understand company approaches and the opportunities and barriers for adopting best practice in social housing. A workshop was held at the Safety Pharmacology Society 15th annual meeting in Prague (2015) and a break-out session within a NC3Rs cardiovascular showcase event in 2018, where experience was shared between different companies to encourage wider implementation. 

Evidence of enhanced data quality and similar responses to a range of positive control substances have been published for rats (see Skinner et al., 2019) and non-rodents (see Prior et al., 2016 and Prior and Holbrook, 2021). This latest publication (Prior and Holbrook, 2021) provides recommendations for best-practice study designs taking other common barriers to social housing into account (e.g., pen or cage sizes only suitable for a single animal, or concerns over cross-contamination between animals in the same pen receiving different dose levels). 

Papers

Prior H and Holbrook M (2021). Strategies to encourage the adoption of social housing during cardiovascular telemetry recordings in non-rodents. Journal of Pharmacological and Toxicological Methods, 108: 106959.  doi: 10.1016/j.vascn.2021.106959

Skinner M, Ceuppens P, White P and Prior H (2019). Social-housing and use of double-decker cages in rat telemetry studies. Journal of Pharmacological and Toxicological Methods 96: 87-94. doi: 10.1016/j.vascn.2019.02.005

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

Posters

Social housing during telemetry studies in rodents and non-rodents, poster presented at the NC3Rs event 'Advancing the 3Rs in pharma: Improving delivery of innovative medicines to patients', June 2019.

Why are non-rodents not socially housed during cardiovascular telemetry recordings on safety pharmacology studies?, poster presented at SPS, September 2017, and the NC3Rs Cardiovascular Showcase, March 2018.

Global cross-company data-sharing on the housing of non-rodents during the recording of cardiovascular telemetry data on safety pharmacology and toxicology studies, poster 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, poster presented at EuroTox, September 2015.

Papers

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 93: 90-97. doi: 10.1016/j.vascn.2018.03.006

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

Cordes J, Heyen J, Volberg M, Poy N, Kreuser S, Shoieb A and Steidl-Nichols J (2016). Validation and utility of the PhysioTel Digital M11 telemetry implant for cardiovascular data evaluation in cynomolgus monkeys and Beagle dogs. Journal of Pharmacological and Toxicological Methods 79: 72-79. doi: 10.1016/j.vascn.2016.01.006

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

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

Hawkins P (2014). Refining housing, husbandry and care for animals used in studies involving biotelemetry. Animals 4: 361-373. doi: 10.3390/ani4020361

Markert, M, Trautmann T, Gross M, Ege A, Mayer K and Guth B. (2012). Evaluation of a method to correct the contractility index LVdP/dt(max) for changes in heart rate. Journal of Pharmacological and Toxicological Methods. 66:98-105. doi: 10.1016/j.vascn.2012.04.005

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

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

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

Posters

Impact of housing conditions on cardiovascular parameters in telemetry-implanted cynomolgus monkeys, poster presented at SPS, September 2019.

Evaluation of PhysioTelTM digital M11 cardiovascular telemetry implant in socially-housed cynomolgus monkeys using Etilifrine and Moxifloxacin, poster presented at SPS, September 2019.

A novel freely moving animal-based blood pressure, ECG, and dual body temperature telemetry system for group housed mice in social context, poster presented at NC3Rs cardiovascular showcase, March 2018.

Continuous real-time physiological data from freely moving group-housed animals, poster presented at NC3Rs cardiovascular showcase, March 2018.

Leadless heart rate loggers minimize impact of surgery and allow social-housing, poster presented at NC3Rs cardiovascular showcase, March 2018.

Advances in physiologic telemetric monitoring compatible with social housing, poster presented at NC3Rs cardiovascular showcase, March 2018.

Improvement of animal welfare as well as robustness of cardiovascular data: how New Telemetry Technologies and study designing can support, poster presented at NC3Rs cardiovascular showcase, March 2018.

Göttingen Minipigs Pre-implanted with DSI PhysioTel Digital Telemetry Implants, poster presented at NC3Rs cardiovascular showcase, March 2018.

Cardiovascular parameters in socially housed cynomolgus monkeys, poster presented at JSPS, February 2017.

Comparison of telemetric cardiovascular parameters in single and pair housing of cynomolgus monkeys, poster presented at SPS, September 2016.

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, poster presented at SPS, September 2015.

Comparative analysis of data sciences international PhysioTel™ D70 and PhysioTel™ digital telemetry platforms, poster presented at SPS, September 2015.

Evaluation of digital implantable telemetry in multiple social housing paradigms for cynomolgus monkeys, poster presented at SPS, September 2015.

JET-BP in socially housed nonhuman primates: comparison of Covance sites and study considerations, poster presented at SOT, March 2015.

Pair-housed dog telemetry: Animal welfare refinement with early indications of similar study sensitivity, poster presented at SPS, October 2014.

Effect of Moxifloxacin hydrochloride on cardiovascular parameters assessed via jacketed external telemetry (JET) in the male beagle dog co-housed in European caging, poster presented at SPS, October 2014.

Pimobendan, Etilefrine, Moxifloxiacine and Esketamine as reference compounds to validate the DSI PhysioTel® system in cynomolgus monkeys, poster presented at SPS, September 2013.

Assessment of drug-induced cardiovascular effects by telemetry in group-housed cynomolgus monkeys, poster presented at SPS, September 2013.

The use of the new PhysioTel™ digital telemetry implant (DSI) for cardiovascular assessment in the Göttingen minipig. A preliminary study, poster presented at SPS, October 2012.

Non-invasive telemetry for monitoring ECG in singly and group housed dogs – the effect of Moxifloxacin, poster presented at SPS, October 2008.

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