NIH, FDA launch new gene therapy research system

FDA Consumer, July-August, 2004

The public and researchers have a new resource for information oil gene therapy studies. The Genetic Modification Clinical Research Information System (GeMCRIS) is a Web-accessible database on human gene transfer, also known as gene therapy, developed collaboratively by the National Institutes of Health (NIH) and the FDA.

Patients, research participants, scientists, sponsors, and others can become better informed about human gene transfer research by using GeMCRIS. Through drop-down menus and preformatted reports, people can easily navigate the GeMCRIS site to learn where trials are taking place, which diseases or health conditions are being studied, and what investigational approaches are being taken. And GeMCRIS includes special security features to protect patient privacy and confidential commercial information.

The new system will also serve as an electronic tool to help researchers report and analyze adverse events that occur in human gene therapy trials, improving the government's ability to monitor this research area. Investigators and sponsors conducting human gene transfer trials will be able to submit adverse event reports to the NIH and the FDA using a secure electronic interface on the GeMCRIS system. This will allow both agencies to improve safety oversight in human gene transfer trials through the harmonization of NIH and FDA reporting requirements.

The public GeMCRIS site is available at www.gemcris.od.nih.gov.