CORE--CLINICAL TRIALS SUPPORT

$0P30FY2002CANIH

University Of South Florida, Tampa FL

Investigators

Linked publications & trials

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Abstract

Description: (Applicant's Description) The purpose of the Clinical Trials Lab Core (CALC.) is to facilitate high-quality translational research at the H. Lee Moffitt Cancer Center and Research Institute. As the Basic Science and Clinical Investigations programs have grown throughout the last three years, it became apparent that a resource was needed to support the translational research effort within the program. The CALC. is composed of two different, but related laboratories devoted to clinical translational research: the pharmacology laboratory and the translational laboratory. The pharmacology laboratory focuses on the pharmacokinetic analyses of anti-cancer drugs and their metabolites, and pharmacokinetic modeling. The translational laboratory component of CALC. provides researchers a means of measuring and quantitating the level of molecular targets from specimens obtained from patients enrolled in clinical trials. Development of this laboratory allows clinical investigators the means of performing important correlative laboratory assays in Phase I and II clinical trials. Specific functions of the core are: centralized sample acquisition and receiving, initial processing and storage; on-going and systematic analytical quality control procedures for quantitative validation of all assays (pharmacologic and molecular); assay implementation; and consultations regarding clinical trial design and choice of sampling strategies for both pharmacokinetic and molecular endpoints. CCSG funding is requested (approximately 20 percent of the total operating costs) to cover a portion of core staff salaries and service contract.

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