The Cancer Trials Support Unit (CTSU) is a service of the National Cancer Institute (NCI) that provides clinicians across the United States and Canada access to cancer treatment trials. The project is funded and directed by the NCI Cancer Therapy Evaluation Program (CTEP) and operated by Westat and the Coalition of Cancer Cooperative Groups Goals of the CTSU ? Provide a wide choice of clinical trial options to the largest possible number of investigators ? Involve a larger number of treating institutions in the clinical trials process ? Increase enrollment to cancer clinical trials ? Streamline or eliminate redundant processes and procedures ? Provide all necessary support services to make working with the CTSU a positive experience Recovery funding has been added to the CTSU for a program entitled: """"""""ADOPTion of New Technologies for Remote Data Capture &Protocol Authoring (ADOPT)."""""""" Recent independent analyses of the National Cancer Institute?s (NCI) clinical trials systems have indicated an urgent need to re-evaluate engrained processes and to find novel solutions if investigators are to take full advantage of scientific opportunities available today for clinical research. The Division of Cancer Treatment and Diagnosis (DCTD), primarily through its Cancer Therapy Evaluation Program (CTEP), sponsors several multi-institution clinical trial organizations, NCI Cooperative Groups and Consortia, that conduct both early phase and late phase multi-institutional trials that evaluate anticancer therapies designed to improve multiple outcomes including symptom-control, quality of life and overall survival. The Groups and consortia encompass many of the nation?s leading NCI-designated Comprehensive Cancer Centers, academic centers in adult and pediatric oncology (with participating sites in every state), and specialized Oncology Consortia devoted to the study of brain and childhood cancers. The Groups receive operational, technical, and regulatory support from the Cancer Trials Support Unit (CTSU - described later). In order to rapidly bridge the gap between the expanding array of pre-clinical opportunities and the existing approaches to patient care increased attention must be devoted to the numerous processes underlying clinical trial development. Significant groundwork has been laid to reconfigure the NCI trials infrastructure. In order for these initiatives to achieve their full potential, NCI and the extramural clinical investigator community must now direct their attention and energies to improving the process by which clinical trials are developed and conducted if we are to realize the goal of more rapid progress against cancer. In keeping with both the numerous stakeholders involved and the complexities of the various processes, the NCI is proposing a multi-pronged approach to address the barriers that must be overcome if clinical trials are to provide our patients the answers they so desperately need. These initiatives include the integration of standardized information-technology (IT) tools or operational processes for: ? electronic Protocol Authoring (ePA) ? electronic Case Report Forms (eCRF) ? including: o Oncology Patient Enrollment Network (OPEN) o Common Terminology Criteria for Adverse Events (CTCAE) ? Clinical Data Management System (CDMS) Standardization and common infrastructure will improve the efficiency and effectiveness of the CTEP multi-center clinical trial networks while simultaneously providing an opportunity to reduce clinical trial costs. The goal of this overall initiative is to integrate ePA, eCRF and CDMS, into the IT systems and business practices of CTEP, CTSU, Groups and Consortia. In addition the NCI Comprehensive Cancer Centers are participating on the CDMS sub-task.
