Developing Clinical Trial Data System

Army and Navy researchers have been working on a new clinical trial data system and are conducting collaborative clinical trials at the Naval Medical Research Center (NMRC), the Walter Reed National Military Medical Center campus, plus at other affiliated facilities. This Navy-Army joint effort to develop a clinical trials record keeping system has been in progress for two years.

Today, the Army Medical Department’s Medical Research and Materiel Command (USAMRMC) and NMRC are using the new technology referred to as the “Electronic Data Capture-Clinical Research Data Management System” (EDC-CRDMS) to update their clinical trial records.

EDC-CRDMS uses several Oracle commercial off-the-shelf products to enable USAMRMC and NMRC to more efficiently develop, conduct, and manage electronic data capture-based clinical trials. By using Oracle’s Central Designer software, the Army is able to more readily share clinical data with external partners, collaborators, and FDA.

“This is a huge accomplishment”, said Deputy Project Manager and EDC Working Group Co-Chair Capt. Bruce Barnes. The system enables information from clinical trials to be stored electronically, which allows for easier input reporting and data management. It is not mandatory for clinical trials to use the system but it is thought that by using this system, organizations can expect significant savings instead of contracting out the service.”

In addition to providing electronic data capture, USAMRMC is required to conduct paper-based clinical trials in partner countries such as Kenya and Thailand or where consistent web-based access in not feasible. However, by using Oracle’s Clintrial®, USAMRMC is able to input the trial data captured on paper into electronic format.

The Navy chose the study IMRAS to be the sentinel study for the approval of the new data capture system. IMRAS is currently a Phase 1 clinical study designed to assess the safety and biomarkers of protection in healthy adults who receive bites from mosquitoes infected with radiation attenuated malaria. It is expected that the results of this study will accelerate the development of a malaria vaccine.

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