Core E (Biostatistics) serves as a central resource for program investigators, providing data management and biostatistical consultation, as needed. The Core utilizes data management and quality assurance resources in the Department of Biostatistics, including the Biostatistics Information Tracking System (BITS), the central repository for clinical trial data at City of Hope, and the Data and Safety Monitoring Subcommittee of the Clinical Protocol Review and Monitoring Committee, which regularly reviews protocol deviations and adverse events for all clinical trials at City of Hope.
The specific aims of this Core are: To collaborate in the planning and study design of the program projects, both human and animal studies, including collaborating on the development of study protocols, and projecting power and sample size requirements; To provide data management for the clinical and animal studies, including developing case report forms, preparing analysis data sets, and programming of summary reports; To provide protocol management for the clinical studies, including performing patient eligibility checks, ensuring that informed consent is obtained from study participants, registering participants onto clinical trials, and monitoring the study to ensure that tests and visits are performed in compliance with the protocol; To perform routine quality control checks of the data collection and computerization, including performing automated edit checks of computerized data; To perform regular monitoring of the protocols for adverse events and protocol deviations as required by applicable guidelines and regulations; To perform statistical analysis of the study results and to collaborate in the writing of publications on the results, including preparing summary descriptive statistics, graphs, and tables, and writing final analysis reports; To extend each of the above aims to include program project functions at the three institutions (COH, UCLA, MSK) involved in the multi-center imaging trials described in Project 2, especially in the monitoring of participating sites for protocol adherence and for compliance with regulations regarding reporting of adverse events. This will require expansion of Core E in year 2 for startup of the Data Coordinating Center operations by adding 10 percent effort for protocol coordination and protocol monitoring to develop policies and procedures and 20 percent effort in years 3-4 to actually conduct the multi-center imaging trials in Project 6.
Showing the most recent 10 out of 112 publications
