Limits...
Translating clinical trials from human to veterinary oncology and back.

Fürdös I, Fazekas J, Singer J, Jensen-Jarolim E - J Transl Med (2015)

Bottom Line: In such cases, using animal patients would generate more robust data, as their spontaneous disease resembles the "real life" situation and thus could be more likely to predict the situation in human disease.This would not only provide veterinary oncology access to the latest developments in medicine before they are available for clinical use in animals, but could also lead to generation of clinical data in animal patients that could be translated to humans.In this review, the possible application of similar standards of Good Clinical Practice as in human clinical drug development will be discussed in detail, with special consideration of legal and ethical aspects in Europe and the US.

View Article: PubMed Central - PubMed

Affiliation: Department of Comparative Medicine, Messerli Research Institute, University of Veterinary Medicine Vienna, Medical University Vienna and University Vienna, Vienna, Austria. irene.fuerdoes@aon.at.

ABSTRACT
In human medicine clinical trials are legally required for drug development and approval. In contrast, clinical trials in small animal cancer patients are less common and legally perceived as animal experiments. Comparative oncology has been recognized as a method to speed up the development of medications by introducing animal patients with naturally developing tumours. In such cases, using animal patients would generate more robust data, as their spontaneous disease resembles the "real life" situation and thus could be more likely to predict the situation in human disease. This would not only provide veterinary oncology access to the latest developments in medicine before they are available for clinical use in animals, but could also lead to generation of clinical data in animal patients that could be translated to humans. Nevertheless, there are several limitations to practical conduct of clinical trials in veterinary medicine. In this review, the possible application of similar standards of Good Clinical Practice as in human clinical drug development will be discussed in detail, with special consideration of legal and ethical aspects in Europe and the US.

No MeSH data available.


Related in: MedlinePlus

Overview on the differences between animal experiments and clinical trials in a legal sense but also regarding their scientific aims and the role of the animals used
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Fig1: Overview on the differences between animal experiments and clinical trials in a legal sense but also regarding their scientific aims and the role of the animals used

Mentions: An animal experiment which tests a new drug is done to evaluate its mode of action, efficacy and also safety. However, its limitations are the laboratory settings, often inbred strains, or using an “artificial” disease in an otherwise healthy animal. Furthermore, animal experiments are not able to mirror the human tumour growth over a longer period of time, or the characteristics of minimum residual disease, as well as the heterogeneous macro- and microenvironment as in spontaneously occurring human cancer [34] (Fig. 1).Fig. 1


Translating clinical trials from human to veterinary oncology and back.

Fürdös I, Fazekas J, Singer J, Jensen-Jarolim E - J Transl Med (2015)

Overview on the differences between animal experiments and clinical trials in a legal sense but also regarding their scientific aims and the role of the animals used
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4536666&req=5

Fig1: Overview on the differences between animal experiments and clinical trials in a legal sense but also regarding their scientific aims and the role of the animals used
Mentions: An animal experiment which tests a new drug is done to evaluate its mode of action, efficacy and also safety. However, its limitations are the laboratory settings, often inbred strains, or using an “artificial” disease in an otherwise healthy animal. Furthermore, animal experiments are not able to mirror the human tumour growth over a longer period of time, or the characteristics of minimum residual disease, as well as the heterogeneous macro- and microenvironment as in spontaneously occurring human cancer [34] (Fig. 1).Fig. 1

Bottom Line: In such cases, using animal patients would generate more robust data, as their spontaneous disease resembles the "real life" situation and thus could be more likely to predict the situation in human disease.This would not only provide veterinary oncology access to the latest developments in medicine before they are available for clinical use in animals, but could also lead to generation of clinical data in animal patients that could be translated to humans.In this review, the possible application of similar standards of Good Clinical Practice as in human clinical drug development will be discussed in detail, with special consideration of legal and ethical aspects in Europe and the US.

View Article: PubMed Central - PubMed

Affiliation: Department of Comparative Medicine, Messerli Research Institute, University of Veterinary Medicine Vienna, Medical University Vienna and University Vienna, Vienna, Austria. irene.fuerdoes@aon.at.

ABSTRACT
In human medicine clinical trials are legally required for drug development and approval. In contrast, clinical trials in small animal cancer patients are less common and legally perceived as animal experiments. Comparative oncology has been recognized as a method to speed up the development of medications by introducing animal patients with naturally developing tumours. In such cases, using animal patients would generate more robust data, as their spontaneous disease resembles the "real life" situation and thus could be more likely to predict the situation in human disease. This would not only provide veterinary oncology access to the latest developments in medicine before they are available for clinical use in animals, but could also lead to generation of clinical data in animal patients that could be translated to humans. Nevertheless, there are several limitations to practical conduct of clinical trials in veterinary medicine. In this review, the possible application of similar standards of Good Clinical Practice as in human clinical drug development will be discussed in detail, with special consideration of legal and ethical aspects in Europe and the US.

No MeSH data available.


Related in: MedlinePlus