Data Capture and Analysis for Research Protocols
Winner - BioinformaticsMichael Davis ; University of Pittsburgh Medical Center;
Content:
Throughout the country, a number of research-based clinical trials are being conducted within various universities, medical centers and pharmaceutical companies. With these trials, extensive amounts of data must be captured and managed for analysis. This data consists of a vast range of information: from clinical to regulatory to financial. Researchers are often in need of software to capture this data in a centralized and structured place, create a registry of patients involved in their studies and capture data forms customized to their research.
Technology:
The system was developed in Java using a three-tiered object-oriented approach. It uses a standard Web browser on a Microsoft Windows (Redmond, WA) platform for the front-end interactions. The middle-tier is a Remote Method Invocation server running on an Intranet machine using Windows servers connecting to back-end Oracle (Redwood Shores, CA) databases residing on Sun Unix hardware.
Design:
We have developed the Clinical Trials Management Enterprise to fit the needs of this workplace. The application provides the clinical researchers, nurse coordinators, and supporting offices with an integrated set of tools for managing the administrative and clinical functions for both trial- and patient-based activities. Two options for the user interface are available, a lite version with a more tailored access to the studies and registration and the more robust interface for handling other aspects of the study. One area of focus that we have for the software is to provide a tool that can easily create custom forms to capture questionnaires and data specific to the researchers study and allow data entry in a user friendly screen.
Results:
The introduction of the lite web-based interface offers a straight forward way to enroll subjects onto a registry and track patients involved in the project. The National Mesothelioma Virtual Bank utilizes Clinical Trials Management - Enterprise to keep a registry of the subjects involved. By capturing the Tissue Bank ID for the subject they are also able to link up with collected tissue and biopsy samples. Furthermore, the use of custom case report forms ensures that the necessary data can easily be captured and thus available for analysis. Electronic versions of existing questionnaires and data collection forms can be created to store the data. In the case of the National Mesothelioma Virtual Bank, the prospective biospecimen collection information is captured to provide electronic access to the appropriate users and is also then available for analysis.
Conclusion:
Utilizing software such as Clinical Trials Management Enterprise enables researchers to collect structured data in a central environment so that ultimately the goal of analysis can be accomplished, new ideas can be generated and the research process can continue successfully.
