Protocol Management Office Facility
Hospital CRU 2nd Fl
- Hospital CRU 2nd Fl
The Protocol Management Office provides a centralized resource to facilitate the development, conduct, quality assurance monitoring, and evaluation of clinical trials at Fox Chase Cancer Center. As such, the Office coordinates the majority of clinical research studies in medical oncology, surgical oncology, radiation oncology, and population science (with the exception of most genetic, epidemiology, and behavioral studies). 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 have also actively participated in smaller phase II and phase I pilot studies, including more than 50 active investigator-initiated trials. The Protocol Office also provides support for clinical research activities within the 15 hospital systems that are affiliated with Fox Chase through the Fox Chase Cancer Center Partners.
The Protocol Management Office 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 Protocol Office coordinates the flow of documents among internal bodies (e.g., Research Review Committee, Institutional Review Board) and external agencies to facilitate protocol review while adhering to local and federal 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 Protocol Management Office are organized as disease-focused teams that generally include a nurse clinical research coordinator (CRC) and a clinical research associate (CRA) functioning as data manager. 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 maintaining updated protocol documents and procedures, as well as participating in patient coordination during protocol therapy. Through a centralized administrative structure, all staff report to the Director (L. Kish) and the facility director (Dr. M. Bookman) with administrative support provided through the Division of Medical Science (C. Mahoney).
Fox Chase is committed to a strong centralized protocol operation. This provides a better opportunity for professional training and staff support, knowledgeable backup for teams to accommodate illness and vacations, and improved regulatory compliance. Although centralization can be cost-efficient through resource sharing, it requires increased specialized administrative and technical support to function adequately for a staff that now exceeds 44 full-time equivalents. The overall effectiveness of our protocol operations have been strengthened by the ongoing development and implementation standard operating procedures for administrative, clinical and quality assurance activities.
The Protocol Management Office has major responsibilities for both the administrative, regulatory and clinical aspects of the conduct of clinical trials. The staff is involved in direct patient/physician interaction, as well as in data management roles to collect, collate, and record the research data so as to clearly describe a patient's clinical course. As a result of the monitoring performed by the protocol office, investigators at Fox Chase can maintain close surveillance of toxicities, and monitor the results of studies as they progress.
In addition to Fox Chase-based clinical trials, we are active participants in four national cooperative groups: the Eastern Cooperative Oncology Group (ECOG), the Radiation Therapy Oncology Group (RTOG), the Gynecologic Oncology Group (GOG), and the American College of Surgeons Oncology Group (ACOSOG). The number of Fox Chase patients participating in investigational phase I-II clinical trials is increasing as new and promising therapies are identified. The Protocol Office helps to ensure that clinical trials are performed to the best standards of clinical research, maximizing the opportunity for our patients to avail themselves of the most modern and innovative treatment approaches.
Finally, the protocol office is responsible for coordinating the clinical research efforts of nearly 20 hospitals that are affiliated with Fox Chase through the Fox Chase Cancer Center Partners.