Clinical Protocol Management

Beckman Research Institute/City Of Hope, Duarte CA

Investigators

Linked publications, trials & patents

Abstract

The goal of the Clinical Protocol Management Core (CPMC) is to provide protocol administration and data management services. The CPMC is directed by Joyce Niland, PhD, Cancer Center Associate Director for Information Sciences and Chair, Division of Information Sciences (DIS); the Core Manager is Dina Johnson, Director of the Clinical Research Information Management Department within DIS. Specific services include providing input and review of studies for protocol and data management issues, confirming patient eligibility and registration on study, managing studies in progress, collecting study data, monitoring regulatory compliance, assisting with IRB submissions, ensuring timely reporting of adverse reactions, assisting with preparation of data for study analyses, and participating in continuing education, and quality assurance procedures. All of these are carried out in compliance with FDA Good Clinical Practices (GCP). The CPMC staff provides research support for all clinical departments at City of Hope, including Hematology & Hematopoeitic Cell Transplantation (HCT), Medical Oncology, Surgical Oncology, Pediatrics, Infectious Disease, Neuro-oncology, Radioimmunotherapy, Radiation Oncology, Population Sciences. The CPMC also provides data coordinating services for the NSABP Outreach Program, Phase 11\\ new drug development through the California Cancer Consortium-Pittsburgh trials, the COH Pasadena Outreach Office, and the Arizona Good Samaritan HCT Program. Daily supervision of the CPMC Clinical Research Associates (CRAs) is provided by the Core Manager/Department Director and two Clinical Trial Administrators who report to her. Quality Control Coordinators assist in training, reviewing data, and conducting Protocol Adherence Evaluations of in-house trials. Operations Specialists assist with policies and procedures, forms design, protocol reporting and maintenance of the Clinical Trials On-Line Web site. Two Senior Data Entry Clerks provide entry of protocol data as well as protocol specific results. In Fiscal Year (FY) 2006, CPMC provided the abovementioned services for 551 cancer-related protocols. 2,073 patients were accrued to protocols managed by CPMC, with 7,854 patients in follow-up. From 2002-2006 over 170 publications and cancer research presentations utilized data collected and quality controlled by the CPMC. During the FY2006 reporting period, the CPMC was utilized by 64 Cancer Center members from 5 programs. Peerreviewed usage represented 92.5% (1,918/2,073 patient accruals) of the total CPMC usage. Annual budget for the core is $5,308,224, comprising 25% institutional support, 5% user fees, and 68% other. The CCSG request is for 2% ($131,000).