In January of 2009, the NCI officially launched the Clinical Trials Reporting Program (CTRP) for the development of a comprehensive database containing regularly-updated information on all NCI-funded clinical trials to assure patient safety and an optimal return on the nation's investment in cancer clinical trials. NCI's role as the sponsor of a large number of cancer clinical trials implemented across a wide range of venues uniquely positions the Institute to take a global view of emerging knowledge about the effectiveness of cancer therapies, and to identify and disseminate important patterns and insights in a timely way. The Clinical Trials Reporting Office (CTRO) is the new office within the Coordinating Center for Clinical Trials (CCCT) established to support this program. The CTRO will perform data abstraction, monitoring, reporting, and quality assurance and work closely with the database architects and informatics specialists in NCI's Center for Bioinformatics and Information Technology (CBIIT). This funding request is to support the further development of the database to serve as a comprehensive repository of clinical studies conducted within the NCI's clinical research enterprise. The database will support the assessment, conduct and administration of clinical trials at the NCI and the NCI-supported clinical research community. Development will take place under the aegis of the Cancer Biomedical Informatics Grid (caBIG(R)) program at the National Cancer Institute's Center for Biomedical Informatics and Information Technology (CBIIT). The interoperable clinical trials database, developed by CBIIT, is based on common, shared enterprise information services, and a set of data entry portals and batch upload interfaces. Over the two years of proposed funding, the database will be further developed to allow entry of outcomes and adverse events as well as move clinical trial accrual data entry to shared services. A set of common, shared semantic services have been developed that will enable the database to access the same core data set of organizations, investigators, protocols and so on. More services will be added to support study participants, agents, credentials and others. These enhancements will support not only NCI's ability to manage its trials portfolio and evaluate its effectiveness, but also the collection of core data elements required for mandatory reporting of clinical trials according to the FDA Amendments Act of 2007.
