This project, undertaken for the Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI), has been supported continuously by the EMMES Corporation since 1981 and has been responsive to a variety of changing CTEP needs. Support is effectively divided into two parts: Task I provides information support and database administration to the staff of the Clinical Investigations Branch and other branches of CTEP as required, as well as coordinating activities of Scientific Steering Committees as mandated by the Clinical Trials Working Group (CTWG) of the National Cancer Advisory Board (NCAB);Task II provides data management, statistical support, and operations office requirements for both extramural/intergroup trials, which has previously included expanded access trials sponsored by CTEP and currently involves tracking secondary malignancies. Both tasks assist CTEP in their central mission of coordinating and administering a complex and comprehensive national program of clinical cancer research. More specifically, Task I activities include compilation, collation, summarization, and analysis of data gathered by CTEP-sponsored Cooperative Group investigators, as well as literature and database searches and retrieval. In addition, EMMES staff creates and/or maintains databases to track information concerning NCI-sponsored clinical trials;this includes abstraction of protocols for the CIB Informatics System/Clinical Information Tracking (CIBISCIT) database, review and other support for the CTEP Accomplishments database, development of the semi-annual NCI's Clinical Trials Cooperative Groups National meeting Report, and development and standardization of variable elements for NCI's Common Data Element effort, which establishes a common nomenclature for use in all NCI-sponsored trials. This task also supports coordination of CTEP's Concept Review Meeting (CRM) process and since 2006 expanded coordination and informatics support for the transition of Intergroup Scientific Committees into a broader, more inclusive Scientific Steering Committee structure and their Task Forces. These Scientific Steering committees review concepts for phase III cancer clinical trials to be conducted within the Cooperative Group and Community Clinical Oncology Program clinical trial infrastructure. Currently their are eight Scientific Steering Committees and over forty associated Task Forces being provided support for meetings, minutes, information compilations, collaborative tools, manuscripts and other needs. In addition to current support provided for disease-specific Scientific Steering Committees and Task Forces in the areas of gastrointestinal cancer, gynecological cancer, head and neck cancer, genitourinary cancer and others areas under development, there is the Investigation Drug Steering Committee with ten Task Forces and three Working Groups, the Symptom Management and Quality of Life Steering Committee, and the Patient Advocate Steering Committee. Support is also provided for hematologic malignancies and breast cancer Intergroups. Past activities under Task II include serving as the Clinical Trials Management Unit for the Expanded Participation Project (EPP) and as the Data Coordinating Center for Treatment Referral Center (TRC) and Group C protocols administered by CTEP. The EPP served as a pilot project for the Cancer Trials Support Unit (CTSU), and the TRC and Group C mechanisms involved high-volume, compassionate studies requiring protocol preparation and design, randomization, data collection, data entry, data quality control, data analysis and reporting. Two phase III studies of vaccines for lymphoma and melanoma were also supported under the contract. Currently, data management and statistical support are provided for tracking secondary AMS/MDS treatment on any CTEP supported clinical trial.
