Despite the widespread importance placed by the National Cancer Institute (NCI) on clinical trials' accrual, less than 2-4% of adults newly diagnosed with cancer are enrolled. Many studies have been devoted to understanding the barriers to enrollment that seem to affect all NCI-designated Cancer Centers, including physician, patient and system components. One of the prominent barriers to enrollment into clinical trials is the difficulty in searching and accessing protocol information. The unstructured format and text files requires manual file search through numerous documents, and hence slows the eligibility determination process. Furthermore, the lack of standardized, structured data makes it nearly impossible to automate the matching process. I propose to develop a standard and structured format for clinical trials protocol files. This entails the development of a standard representation for registration and eligibility criteria of enrolling patients, and a semi-automated tool for converting existing text-based clinical protocol files (e.g. .doc, .pdf) to the standard representation. ? ? The specific aims are: 1) Model the registration requirements and eligibility criteria of patients to cancer clinical trials, 2) Develop a standard document format (expressed in XML Schema) based on this model representing registration and eligibility criteria of patients in cancer clinical trials and 3) Develop a prototype semi-automated conversion tool to assist in converting existing text-based clinical protocol files (e.g. .doc, .pdf) to the standard document format. ? ? This proposal of standardizing clinical trial protocol files format and the authoring tool lays the foundation for the development of a workbench that can efficiently retrieve and utilize clinical trials data in order to enhance trial accrual. Physicians participating in a busy oncology practice don't have the time to efficiently identify eligible study subjects. Completing the task of enrollment requires a level of access to clinical trial information that doesn't exist in most practice settings. To determine whether new patients may be eligible for an open trial, the physician or the Clinical Research Coordinator (CRC) must read through the eligibility sections of one or more protocol documents. This activity interrupts the workflow and constitutes a substantial barrier to trial enrollment. Previous attempts to address this problem have not provided the ability to search for eligibility with specific parameters. Once a standardized format is achieved the PI of this proposal will seek NIH funding for a larger grant to provide a solution for matching of patients to suitable trials by developing both a simple user interface for querying our clinical trial protocol database, as well as programmatic interfaces that allow system developers to connect their software to the protocol database. Completion of this proposed workbench will provide a new method to help improve accrual into clinical trials within and between cancer centers. ? ? ?
