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Published on: January 22, 2011
The creation of the Comparative Oncology Trials Consortium Pharmacodynamic Core: Infrastructure for a virtual
Melissa Paoloni1, Susan Lana, Douglas Thamm
1Comparative Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA. paolonim@mail.nih.gov
Abstract:
The National Cancer Institute-Comparative Oncology Trials Consortium (NCI-COTC) aims to inform the development path of novel drugs and biologicals for human cancer patients through their evaluation in dogs with neoplasia. The advent of sophisticated clinical trials in veterinary medicine requires additional infrastructure to evaluate tissue and fluid end-points vital to questions relating to drug activity, targeting and toxicity. Pharmacokinetic and pharmacodynamic end-points necessitate a centralized laboratory for quality controlled assay development and execution. Establishing the COTC Pharmacodynamic Core (PD Core) has addressed the need for uniform end-point analysis by serving as a virtual laboratory that capitalizes on the expertise of the COTC community of investigators. Veterinary biomarker validation is a secondary benefit of these efforts. The PD Core exemplifies the construction of a successful infrastructure within the veterinary research community in line with advances in technology and focused on improving the health and quality of life of both human and animal cancer patients.
Insights
The National Cancer Institute-Comparative Oncology Trials Consortium (NCI-COTC) established a Pharmacodynamic Core (PD Core) to standardize drug evaluation in canine cancer. This infrastructure supports developing novel cancer drugs for both human and animal patients.
Area of Science:
- Comparative oncology
- Veterinary medicine
- Translational cancer research
Background:
- Novel drug development for human cancer requires robust evaluation methods.
- Veterinary clinical trials necessitate specialized infrastructure for assessing drug efficacy and toxicity.
- Pharmacokinetic and pharmacodynamic endpoints are crucial for understanding drug activity.
Purpose of the Study:
- To establish a centralized laboratory infrastructure for uniform analysis of pharmacodynamic endpoints in veterinary clinical trials.
- To support the National Cancer Institute-Comparative Oncology Trials Consortium (NCI-COTC) in evaluating novel drugs and biologics in dogs with cancer.
- To facilitate veterinary biomarker validation.
Main Methods:
- Establishment of the COTC Pharmacodynamic Core (PD Core) as a virtual laboratory.
- Leveraging the expertise of the NCI-COTC investigator community.
- Developing and executing quality-controlled assays for tissue and fluid endpoints.
Main Results:
- The PD Core provides uniform end-point analysis for comparative oncology trials.
- It addresses the need for centralized, quality-controlled assay development and execution.
- Veterinary biomarker validation is a secondary outcome of the PD Core's efforts.
Conclusions:
- The PD Core represents a successful infrastructure model within the veterinary research community.
- This initiative aligns with technological advancements to improve cancer treatment for humans and animals.
- The established infrastructure enhances the development of novel cancer therapeutics through comparative oncology.
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