Fox Chase Clinical Trials Operations
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As a nationally accredited Comprehensive Cancer Center, an important part of the Fox Chase Cancer Center (FCCC) research portfolio is the performance of clinical trials to evaluate promising new therapeutic agents and modalities. FCCC clinical trialists are supported in this essential activity by a robust and unique infrastructure that speeds the approval of new trial concepts, helps with the logistics of recruiting patients to trials, and provides dedicated treatment area, pharmacy support, and connections to laboratory diagnostics.
Lainie Martin, M.D. provides a unique centralized Protocol Management Facility and Regulatory Department. This centralization facilitates movement of all Fox Chase Investigator-Initiated Trials (IITs) and externally sponsored studies through the review and approval processes of the scientific Research Review Committee (RRC) and Institutional Review Board (IRB), to ensure human subjects protection. This process ensures complete compliance with the Code of Federal Regulations and Good Clinical Practice Guidelines set forth by the National Institutes of Health (NIH), National Cancer Institute (NCI), and Food and Drug Administration (FDA).
The IRB and Human Subjects Protection
Notably, the human subjects protection program at Fox Chase Cancer Center holds full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Participation in the AAHRPP is voluntary and involves a rigorous and thorough review of an institute's internal program for protecting patients who enroll in clinical research. Fox Chase received re-accreditation, effective June 2007. In July 2004, Fox Chase was one of the first institutions in the United States, the first program in Pennsylvania, and the first freestanding comprehensive cancer center, to be accredited by AAHRPP. More
Clinical Research Unit (CRU)
The CRU is a dedicated clinical trial treatment area located in the Ambulatory Care Department. The CRU is staffed with specialized oncology registered nurses, and equipped with an infusion area and clinical exam rooms. This consolidated treatment space provides a convenient centralized location for patients, support staff, and clinical researchers to interact, improving communications relevant to patient care. This specialized environment allows staff to focus on the special needs of clinical trials
The Investigational Pharmacy at FCCC is a dedicated facility. Drug quality is ensured via careful temperature monitoring and a backup power source. The staff is experienced with interactive voice response systems (IVRS) to facilitate timely ordering and issuance of investigational drugs. The NCI Drug Accountability Record Form (DARF) is utilized, and a standard operating procedure (SOP) for investigational drug destruction is observed.
Protocol Support Lab (PSL)
Clinical trials typically involve the collection of extensive data that allow trialists to understand how effectively drugs are working in patients, and to learn about how they work. The PSL is a dedicated department at FCCC responsible for the collection, processing, and shipment of specimen samples relevant to clinical trials. The PSL has experience with all specimen types (including blood, tumor tissue, and other materials), and supports pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic (PG) studies. The specimen storage resources in the PSL are equipped with alarm and backup power systems, and include refrigerated centrifuges and temperature-controlled freezer.
Information and Data Management Capacity
The Biostatistics and Bioinformatics Facility and the Population Studies Facility are institutional resources that support data management and analysis in multiple Fox Chase efforts, including high-throughput sequencing, the Biosample Repository and the clinical trials program. These facilities have substantial expertise in clinical trial design and analysis, data mining via machine learning, mathematical modeling, high-throughput data management and analyses, functional genomics, and advanced sequence analysis.
Fox Chase has recently established high-throughput DNA sequencing for translational cancer genomics at our Institute for Personalized Medicine. This Institute prepares genomic and exome-enriched libraries from frozen and laser-capture- microdissection generated cancer samples, then uses Illumina sequencing technology to sequence these libraries, enabling the comprehensive characterization of mutations in individual cancer samples. Over the next decade, it is projected that exome sequencing will become a standard component of cancer diagnostics and selection of patients for clinical trials: Fox Chase is working to establish the infrastructure to be at the cutting edge of this next generation of cancer treatment.
Biosample Repository Facility
The Biosample Repository is a CAP (College of American Pathologists) accreditated and CLIA (Clinical Laboratory Improvement Amendments) approved facility, and functions to identify clinical trial participants, administer informed consent, collect tissue, blood, and/or urine samples from selected populations, and obtain information on personal and family histories of cancer, clinical intervention, and lifestyle factors for use in research.
Working in collaboration with pathologists, medical oncologists, surgeons and other hospital personnel, specially trained staff obtain patient consent, collect samples and assemble comprehensive clinical information about each donor and the corresponding samples. As part of this banking, the Biosample Repository provides I) outstanding diagnostic pathology support; II) a comprehensive informed consent process for the use of tissue, blood, urine, and/or bone marrow from patients and participants for research; III) a specialized biospecimen bank devoted to the collection and distribution of specimens to support research; and IV) extensive supporting data from the clinical record and self-reported health history of each participant.
All specimens are linked to comprehensive clinical databases. The Biosample Repository has banked over 10,000 fresh-frozen tissue samples (tumor and normal tissue) and over 16,000 blood samples (e.g., whole blood, plasma, serum, leukocytes, erythrocytes, lymphoblastoid cell lines, and DNA isolated from leukocytes) and obtained cancer history data to be utilized in genetic-, epigenetic-, and proteomic-related research. The Biosample Repository houses over 700,000 sample vials including plasma, serum, viable leukocytes and DNA and has access to >100,000 surgical pathology cases.