In conjunction with the Lurie Cancer Center's Clinical Research Office (CRO), the Pathology Core Facility's Clinical Trials Unit (PCF-CTU) participates in both industry- sponsored and investigator-initiated clinical trials.
The PCF-CTU is responsible for the procurement and processing of bio-specimens as required for each IRB-approved protocol. As part of the specimen procurement process, PCF-CTU also works directly with the Surgical Pathology department's Clinical Specimens Release Committee (CSRC). The CSRC is responsible for approving the amount of tissue that can be released from a patient's surgical pathology case for each protocol. With the pharmaceutical industry moving towards more personalized medicine, more and more clinical trials require procurement of individual patient tumor tissue in order to develop gene-targeted therapies.
The PCF-CTU works with several departments within Northwestern Medicine including NUCATS, Hematology/Oncology, Ophthalmology, Exercise Physiology, Rheumatology, Surgical Pathology, Cytopathology, and Neuro-Pathology. At any given time, there are over 150 clinical trials open for patient enrollment in which PCF-CTU is participating. This department works in conjunction with the CRO in review, initiation and conduct of each trial, carefully monitoring protocol requirements and procedures to ensure compliance. Northwestern University Investigator Initiated Trials have industry collaborators but also require a significant amount of input from PCF-CTU in designing/writing the correlative sections of protocols. Recently, PCF-CTU has been an integral part of designing and creating new NU IIT Laboratory Manuals for all new studies that have correlative components.
The PCF-CTU currently has a total of nine full time employees (FTE). There are three Research Study Coordinators, two Senior Research Study Coordinators, one Administrative Assistant, one Research Slide File Clerk, and one Research Study Assistant. The PCF-CTU is led by the Clinical Operations Manager .