Thursday, March 25, 2004

DCRI, Phase Forward Form Alliance
By Pat French

The DCRI has entered into a multiyear agreement with Phase Forward, Inc., to use the company’s InForm™ application for electronic data capture (EDC) of future clinical trials data.

The DCRI has been using Phase Forward’s Clintrial™ and Clintrace® applications since 1997 for data management and safety tracking and reporting. Integration of the InForm software with the Clintrial system will result in efficient data handling, collection, consolidation, analysis, reporting, and preparation for submission and archiving.

Robert M. Califf, MD

“Our mission at the DCRI is to develop and share knowledge that improves the care of patients around the world,” says Robert M. Califf, MD, Director of the DCRI. “We are striving to impart our lessons learned and educate future generations of clinical researchers. We plan to do this through our clinical research ‘networks’ – infrastructures for sharing data within organizations and across enterprises to provide scientific leadership in the conduct of clinical trials. Phase Forward has made significant progress in developing technology that can support an integrated clinical trial environment and is well qualified to help us execute this vision.”

The Phase Forward system allows users to set up and manage a Web-based EDC system for clinical studies and registries. Study sites enter patient data via a Web page, where errors and omissions can be spotted and corrected before the data are submitted to the DCRI. This system results in fewer queries to sites to resolve data problems and thus more efficient projects.

The DCRI has been using EDC for some time, representing a combination of homegrown, customized systems and existing software from outside sources. In all, the DCRI has conducted 24 EDC projects since 1999. Data from the 2002 Center for Data Interchange Standards Consortium (CDISC) pharmaceutical industry survey projected that each organization will average 7 EDC trials in 2004. The DCRI is already at that average. Adoption of the InForm system will enhance the Institute’s data management capabilities even further.

“In discussing the future with the leadership of Phase Forward, we agreed that huge amounts of money are wasted in clinical research today because processes that could be automated and simplified continue to be done in outmoded ways,” notes Califf. “We are interested in electronic trial management, and electronic data capture is only a part of the overall strategy. Ultimately, this is one step along the way to full-fledged electronic medical records with common nomenclature and data standards. That’s the prize we have in mind eventually.”

Joining patient care data with clinical research data holds clear benefits for patient safety and increasing the effectiveness of medical therapies. One data source, easily accessible and modified, can reduce the likelihood of errors and speed the conduct of research. EDC will be a crucial cog in this transformation of information infrastructure.

In the immediate term, the DCRI will use Phase Forward’s Web hosting services for EDC within its clinical trials. Phase Forward’s Technology Transfer team and the DCRI also will begin global technology and methods planning, including implementation, system validation, and training for full deployment of the InForm application.