The Clinical Pharmacology Shared Resource (CPSR) provides critical scientific and technical support for the development and performance of clinical trials and dissemination of the trial results. This support is essential for early-phase clinical trials, including first-in-human studies, but also adds significant value to clinical trials focused on new applications and new combinations of current therapeutics. The guidance and support from the CPSR ensure clinical trials are comprehensive, driving the development and advancement of therapeutic and preventative approaches for cancer.
The CPSR has 5 aims:
- Provide clinical pharmacology expertise to investigators and support them as they develop, seek funding and implement clinical trials.
- Develop, codify and perform proper acquisition, processing and either short-term storage or shipping of clinical trial research samples (blood, urine, saliva, feces, cells, tissue).
- Develop, validate and perform GLP (good laboratory practice)-compliant quantitative analysis of drugs and their metabolites and of endogenous small molecule biomarkers in clinical trial patient samples.
- Perform pharmacokinetic calculations, analysis and interpretation, then present those findings for clinical trials.
- Educate investigators and team members in the theory and application of clinical pharmacology to research in the identification, development and testing of new chemical entities, or for new applications of existing chemical entities, in clinical trials.
These services are provided to support cancer therapeutics trials, including studies of drug repurposing and novel drug combinations, and to the measurement of a full range of tobacco biomarkers for population studies of smoking cessation and of relative risks from various forms of tobacco and nicotine, including smoked and smokeless tobacco, nicotine replacement therapy and e-cigarettes.
Their flexibility to add extra biomarkers to our analyses provided us with more detailed assessments of tobacco product and nicotine use, as well as some inherent health risks of that use. –Nikki NollenCancer center researcher
View Clinical Pharmacology brochure.
CPSR’s support included acquisition and processing of patient samples, application of validated analytical methods for measuring drug metabolite concentrations and interpretation of pharmacokinetic calculations. –Joaquina Baranda, MD
The CPSR’s acquisition, processing and analysis of samples, even those from strict pharmacokinetic protocols, gives the most accurate data to define dose-exposure and dose-response relationships. –Tara Lin, MD
Paul Toren, PhD, Clinical Pharmacology executive director
Request our services.
Engage the Clinical Pharmacology Shared Resource on your project. Email your service request.
Ciclopirox Prodrug (CPX-POM), a prodrug for the active species CPX, was developed with support from the Lead Development and Optimization Shared Resource. CPX-POM selectively delivers the active drug to the urinary tract following systemic administration. A multicenter, Phase I dose-escalation study characterized the pharmacokinetics of CPX-POM, CPX and CPX-glucuronide in both plasma and urine, evaluated dose-limiting toxicities and determined the recommended Phase II dose for CPX-POM. All drug and metabolite concentrations for the study were determined in the CPSR. Learn more.
Preclinical studies conducted by National Cancer Institute consortium partner Stowers Institute for Medical Research were translated into a clinical trial of low-dose daunorubicin in patients with relapsed/refractory acute myelogenous leukemia. CPSR assisted in the design and development of protocols and performed the sample acquisition and processing for PK and biomarkers, analysis of daunorubicin in plasma samples, and PK calculations and modeling for the study. Learn more.