New System for Reporting Adverse Events in Human Gene Therapy Trials

Format: Web Site
Institute: Office of the Director (OD)

In an effort to speed up how quickly researchers report adverse events in human gene therapy trials, the NIH and the Food and Drug Administration have launched a new Web-accessible database called Genetic Modification Clinical Research Information System (GeMCRIS).

GeMCRIS, developed collaboratively by the two agencies, will provide information directly to the public and will improve the government’s ability to monitor adverse or undesirable developments in these gene therapy trials, also known as gene transfer trials. With this important electronic tool, scientists can report on and analyze any adverse events.

NIH Director Elias A. Zerhouni, M.D., said, “GeMCRIS is an important achievement and a unique resource for scientists, patients, and the public. GeMCRIS will help advance gene therapy, while allowing the NIH, the FDA, and the research community to maintain appropriate oversight.”

Acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D., said, “the development of GeMCRIS illustrates the government’s commitment to addressing public and patient concerns about safety while advancing gene therapy.”

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