PROTOCOL MANAGEMENT OFFICE

MICHAEL A. BOOKMAN, M.D., Member, Director
SUSAN COAKLEY, B.S., C.T.R., Coordinator of Clinical Investigations (from May 1998)
CHRISTINE HEYS, B.S., M.B.A., C.C.R.A., Coordinator of Clinical Investigations(until March 1998)
SHERI McCAFFERY, B.A., Administrative Coordinator
SHANNON BLACK, R.N., B.S.N., Clinical Research Coordinator (from October 1998)
MONICA DAVEY, R.N., B.S.N., M.B.A., Clinical Research Coordinator
LYDIA GILES, R.N., Clinical Research Coordinator (from December 1998)
FRANCES GREEN, R.N., C.C.R.A., Clinical Research Coordinator (retired, January 1998)
DEBORAH KILPATRICK, R.N., B.S.N., C.C.R.A., Clinical Research Coordinator
KATHLEEN LINAHAN, R.N., Clinical Research Coordinator(until May 1998)
CHRISTINE MAIALE, R.N., B.S., O.C.N., Clinical Research Coordinator
CECILIA McALEER, B.S., C.C.R.A., Clinical Research Coordinator
KRISTIN PADAVIC-SHALLER, R.N., M.S.N., Clinical Research Coordinator
JESSIE R. SCHOL, R.N., C.C.R.A., Clinical Research Coordinator
LINDA VADERS, R.N., M.S.N., O.C.N., Clinical Research Coordinator
GWEN YESLOW, R.N., O.C.N., C.C.R.A., Clinical Research Coordinator
MARY BEARD, B.S., C.T.R., Clinical Research Associate (from July 1998)
COLLEEN BONJO, B.S., C.C.R.A., Clinical Research Associate(until April 1998)
DIANE BRADY, Clinical Research Associate
TIMOTHY COLEMAN, B.S., Clinical Research Associate
JUDY DONAHUE, Clinical Research Associate
THOMAS GILLON, B.A., Clinical Research Associate
THERESA C. HALBHERR, C.C.R.A., Clinical Research Associate
EILEEN KEENAN, M.A., C.C.R.A., Clinical Research Associate
KAREN SCHMIDT, C.C.R.A., Clinical Research Associate
MARIE T. BURNITE, A.A.S., Fox Chase Network Protocol Coordinator/Auditor(until August 1998)
DOROTHY KELLY, C.C.R.A., Fox Chase Network Protocol Manager/Auditor
GAIL REISEN, B.A., Fox Chase Network Protocol Coordinator/Auditor (from September 1998)

The performance of clinical trials to evaluate new therapeutic interventions is a major activity of any comprehensive cancer center. At Fox Chase, these trials range from early dose-finding studies of new agents, accompanied by pharmacologic and/or biochemical studies, to large comparative trials of regimens with promising activity in a particular disease. The Protocol Office provides a centralized resource to facilitate the development, conduct, quality assurance monitoring, and evaluation of clinical trials. As such, the office coordinates the majority of clinical research studies in medical oncology, surgical oncology, radiation oncology, and cancer prevention. This effort includes attention to scientific, ethical, and regulatory issues, as well as objective and verifiable data management for approximately 150 individual trials that are open to patient accrual at any one time.

The Protocol Office participates at all levels in the activation and conduct of trials. A protocol (a written document that describes in detail the rationale for and the therapeutic plan of a proposed study) is submitted by an investigator for review and approval prior to activation. The Protocol Office coordinates the flow of documents among internal bodies (e.g., Research Review Committee, Institutional Review Board) and external agencies (e.g., National Cancer Institute, Food and Drug Administration) to facilitate protocol review while adhering to local and federal guidelines to maximize protection of human subjects. Initial review occurs at the department level, followed by a detailed assessment of scientific merit, design, feasibility, and biostatistical analysis through the Research Review Committee. Approved protocols are then forwarded to the Institutional Review Board. In addition, all active studies receive an annual re-review of the scientific objectives, accrual targets, and safety. This process of continuous review forms the basis for our NCI-approved Clinical Protocol Scientific Review and Monitoring System (CPSRMS).

Upon initial approval of a study by the Institutional Review Board, the protocol is assigned to one of eight teams consisting of a clinical research coordinator and a clinical research associate. Each team is organized by disease or specialty, and the individuals serve as a resource for physicians, clinical staff, and patients. Protocol staff are involved in direct patient/physician interactions, as well as chart review for data management to accurately depict the course of each patient on each study. As a result of monitoring performed by the Protocol Office and the availability of an on-line relational database for protocol management, investigators at Fox Chase can maintain close surveillance over toxicities and monitor the results of studies in progress.

In addition to Fox Chase investigator-initiated and pharmaceutical-sponsored clinical trials, we are active participants in three NCI-supported national cooperative groups: the Eastern Cooperative Oncology Group (ECOG), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG). We have also participated in selected studies sponsored by other groups, such as NSABP. In addition, the Protocol Office is responsible for coordinating the research efforts of the 14 hospital systems that are affiliated with Fox Chase through the Fox Chase Network. As a group, Network hospitals contribute approximately 300 patients annually to a variety of clinical trials.

As our clinical research expertise has expanded, the number of Fox Chase patients participating in complex phase I and/or multimodality clinical trials has also increased, particularly 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, providing an excellent opportunity for our patients to participate in the most modern and innovative treatment approaches. Information on clinical research studies can be obtained from our web site at http://www.protonet.fccc.edu.

Illustrations or unpublished data in these reports should not be used without permission of the author.

Fox Chase Cancer Center Scientific Report 1998