Infrastructure needs for translational integration of mouse and human trials
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John G Clohessy1, Elisa de Stanchina
1Preclinical Murine Pharmacogenetics Facility, Division of Genetics, Department of Medicine, Beth Israel Deaconess Cancer Center, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Harvard Medical School, Boston, Massachusetts 02215;
Abstract:
Advances in the treatment of human cancer are frequently limited by the inability to test novel drugs and drug combinations in patients in a rapid and streamlined manner. Increasing data from the application of clinically relevant mouse models has highlighted the ability of preclinical trials in mice to address this problem, and has paved the way for what is now termed the "Co-Clinical Trial Project," in which mouse trials are performed concurrently with human trials. This in turn enables efficient patient stratification and therapy optimization based on molecular determinants for effective treatment of cancer. To fully realize the potential of preclinical, coclinical, and postclinical trials in mice, there is a need to establish key principles for carrying out therapeutic mouse trials, to standardize practices for performing such trials, and to establish mouse hospitals where trials can be integrated with corresponding clinical trial efforts in humans. Here we describe critical infrastructural components that are required for effective implementation of such efforts and suggest a model for how mouse hospitals for clinical trials should be established.
Insights
Co-clinical trials in mice accelerate cancer drug development by running alongside human trials. Establishing standardized "mouse hospitals" is crucial for optimizing cancer therapies.
Area of Science:
- Oncology
- Translational Medicine
- Preclinical Research
Background:
- Cancer treatment advances are hindered by slow drug testing in patients.
- Clinically relevant mouse models offer a solution for rapid drug evaluation.
- Co-clinical trials integrate mouse and human studies for faster therapeutic development.
Purpose of the Study:
- To outline principles and practices for therapeutic mouse trials.
- To propose a model for establishing "mouse hospitals" for integrated clinical trials.
- To facilitate efficient patient stratification and therapy optimization in cancer treatment.
Main Methods:
- Reviewing the application of clinically relevant mouse models.
- Describing critical infrastructural components for therapeutic mouse trials.
- Suggesting a model for integrating mouse trials with human clinical efforts.
Main Results:
- Preclinical trials in mice can address limitations in human cancer drug testing.
- Co-clinical trials enable concurrent testing of novel cancer drugs and combinations.
- Standardization and infrastructure are needed for effective therapeutic mouse trials.
Conclusions:
- Establishing key principles and standardized practices for therapeutic mouse trials is essential.
- The development of "mouse hospitals" is critical for integrating preclinical and clinical cancer research.
- This approach facilitates efficient patient stratification and therapy optimization for improved cancer treatment outcomes.
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