A new Internet-based software system developed at the National Cancer Institute may soon change how oncologists conducting clinical trials in one part of the world interact with others doing similar work on another part of the planet. Belfast City Hospital in Northern Ireland has been chosen by NCI as one of its first partners in the endeavor.
The software tool that will help make these Internet interactions possible is called net-TrialsTM. In development since September 1998, the net-Trials software project brings together about two dozen old clinical database systems that used different vocabularies and work processes and makes all of the data available in a single standard lexicon with a net link to NCI clinical investigators and other NCI partners both nationally and internationally.
The Web-based application is intended to make managing clinical trials going on simultaneously at multiple institutions much easier. For Northern Ireland oncologists, their participation in the net-Trials development is a major step forward for clinical trials in that country. Seamus McAleer, M.D., coordinator of the Clinical Trials Unit at Belfast City Hospital, said that 15 years ago cancer treatment in Northern Ireland was very basic with very little radiotherapy and almost no chemotherapy available.
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Because of their lag in the cancer field, McAleer said that the hospital is eager to get involved with phase I and II trials. Although Northern Ireland has developed a basic clinical trials system, until now everything has been accounted for on paper. With net-Trials, McAleer expects that to change rapidly.
"Net-Trials will help efficiency and help put more patients through trials since the same number of staff can put more patients on trials and produce better quality data," he said. The major challenge is to get the system to work over the Internet and to link into all of the lab and pathology systems around the hospital, he added.
Belfast City Hospital has 26 protocols in operation, said Ruth Boyd, a clinical research nurse coordinator, and she hopes the new system will expand that number. McAleer cautioned that the hospital will still have to process any new protocols through ethics, licensing, and other systems, but the new Internet software should help streamline many of these processes.
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Additionally, once patients are enrolled in a trial, clinicians have had difficulties following them through treatment and outcome. He added that a lot of their trials have already been open to FDA audit and comply with the same standards that U.S. trials are using, which should make for an expedited implementation process.
Future Developments
Frank Govern, Ph.D., who is heading up the program for NCIs Division of Clinical Sciences, said NCI hopes to make Belfast a hub for Europe. "To implement our systems over in other countries is a major goal of ours," he said.
If the system works in Belfast, then Govern said net-Trials would then be implemented in Dublin. Govern said that other countries including Jordan, Israel, Poland, and Italy, have expressed interest in the program.
On a long-term level, Douglas Hageman, chief of the Office of Clinical Informatics in the Division of Clinical Sciences at NCI, said he hopes the system will be able to take trials from the initial planning stages all the way through to publication"but thats still several years off," he said.
Hageman said that NCI is using three clinical trials to test the functional aspects of the system with the Belfast group. "Our plan is to have net-Trials not only accelerate things at external sites like Belfast but also here at NCI. We all hope to incorporate new protocols as they come out of [institutional review boards] at the fastest rate this new system allows," he said.
This particular version of net-Trials is the first of four they hope to develop, said Dianne Reeves, of NCIs Clinical Trial Information Systems. Each new iteration will modify and expand on the previous version.
"Eventually, outside institutions may incorporate pieces of our software into their systems and if theyve developed something better than what weve got, well try and incorporate that into net-Trials," she said. As an example, she said that one institution has a nice system developed for matching patient eligibility to protocol requirements that could be incorporated into net-Trials.
In addition to continually updating the system, security is also a concern. "Patient data must cross the ocean with the greatest security in place to the country receiving the data for this system to have credibility," Govern said. The NCI net-Trials team notes that they are implementing state-of-the-art encryption and security using many technologies that have been developed for e-commerce so confidentiality of patient data will be maintained at the most secure level possible.
This pioneering effort hopefully will bring to hospitals opportunities that have been previously unavailable. "We will benefit greatly from the technology being put into net-Trials by the NCI," McAleer said. "We couldnt possibly have gone into anything of this scale on our own due to cost and other considerations."
Researchers should know in a few years how well this system works, and if its as useful as the initial testers hope, it could help bring the international clinical community together very quickly.
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