Recovery money was added to the Cancer Therapy Evaluation Program's Informatics and Computer Support contract in support of the program, """"""""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 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. The Cancer Therapy Evaluation Program's Enterprise System (CTEP ESYS) is made up of 22 modules At the present time these modules include but are not limited to: Clinical Trials Monitoring Branch Audit Information System (CTMB-AIS), Protocol Authorization and Tracking System (PATS), Drug Authorization and Review Tracking System (DARTS), Clinical Data Update System (CDUS), Web Enabled CDUS, Common Toxicity Criteria Interactive Tool (CTCAE), Adverse Drug Experience Electronic Reporting Systems (AdEERS), Enterprise Query Wizard (EQW), Financial Instrument and Accrual Tracking System (FIATS), CTEP Account Management System (AMS), Clinical Investigations Branch Information System and Clinical IT (CIBISCIT), Regulatory Affairs Branch Information Tracking System (RABITS), Document Management, Assembly, Review and Tracking System (Docu-MART), and the CTEP Web Page. The primary objectives of the CTEP Enterprise System are to: ? Capture data and translate it into a usable format to address the scientific, safety, regulatory and administrative needs of CTEP and the NCI. ? Eliminate data redundancy throughout the oncology community ? Streamline clinical research operations. ? Reduce the administrative burden on NCI staff, contractors, and extramural researchers. ? Improve communication between CTEP and its collaborators. ? Assure the security and confidentiality of proprietary and patient information. ? Increase access to clinical trials to all investigators ? Capitalize on XML and other technologies to maximize reusability and integration with other systems in the oncology community. ? Support broad patient access to clinical trials. ? Expedite the protocol development and review process within both clinical trial organizations and reviewing bodies.
