Hospital CRU 2nd Fl
- Hospital CRU 2nd Fl
The Office of Clinical Research provides a centralized resource to facilitate the development, conduct, quality assurance monitoring, and evaluation of clinical trials at Fox Chase Cancer Center. The Office coordinates the majority of clinical research studies within the departments of: medical oncology, surgical oncology, radiation oncology, and population science. Research topics include cancer prevention, developmental chemotherapy, combined modality therapy, dose-intense therapy with stem cell support, antibody targeting, supportive care, and ancillary studies. In addition to our routine participation in large multicenter phase III randomized trials, we also actively participated in smaller phase II, phase I and pilot studies; including multiple investigator-initiated trials. The Office of Clinical Research also provides support for clinical research activities to Fox Chase Cancer Center Partners, a network of hospital systems affiliated with Fox Chase Cancer Center.
The Office of Clinical Research participates at all levels in the activation and conduct of clinical trials. This effort includes attention to scientific, ethical, and regulatory issues; patient registration and protocol compliance; as well as objective and verifiable data management for each study. The Office of Clinical Research coordinates the flow of documents among internal safety and regulatory committees and boards (e.g., Research Review Committee, Institutional Review Board) and external agencies to facilitate protocol review while adhering to local and federal regulations and international guidelines to maximize protection of human subjects. Regulatory compliance and data integrity are evaluated during frequent audits from external sponsors and agencies, including the National Cancer Institute, national cooperative groups, Food and Drug Administration (FDA), and pharmaceutical industry.
The clinical research staff of the Office of Clinical Research are organized as disease-focused teams that generally include a clinical research nurse coordinator (CRN) and a clinical research associate (CRA) functioning as data manager, or a Clinical Research Coordinator (CRC). The disease-focused team structure facilitates interaction with physicians and patients and allows each team to develop clinical expertise in their respective area. Each team is responsible for gathering and maintaining updated participant data as well as participating in the coordination of patient care during protocol therapy. Through a centralized administrative structure, all staff report to the Facility Director, VP Clinical Research Operations, and the Associate Director of Clinical Research.
Fox Chase is committed to a strong centralized protocol operation. This provides an opportunity for professional training and staff support, knowledgeable backup for teams and improved regulatory compliance. The overall effectiveness of our protocol operations has been strengthened by the ongoing development and implementation of processes and procedures for administrative, clinical, regulatory, and quality assurance activities.
The Office of Clinical Research has major responsibilities for the administrative, regulatory and clinical aspects of conducting clinical trials. The staff is involved in direct patient/physician interactions, as well as data management roles to collect, collate, and record all data to clearly describe a patient's clinical course.
The Office of Clinical Research provides assistance to investigators to develop Fox Chase-based clinical trials, which allows for the development of novel agents from bench to bedside. As a result of the monitoring performed for the Investigator Initiated Trials (IIT), investigators at Fox Chase can maintain close surveillance of toxicities, and monitor the results of these studies as they progress.
In addition to IITs, we are active participants in the national cooperative group studies. The number of Fox Chase patients participating in investigational phase I-II clinical trials is increasing as new and promising therapies are identified. The Office of Clinical Research helps to ensure that clinical trials are performed in accordance with Good Clinical Practice (GCP) standards for clinical research, maximizing the opportunity for our patients to avail themselves of the most modern and innovative treatment approaches.