| NIH and FDA Launch New Human Gene Transfer Research
GeMCRIS will facilitate faster reporting of adverse events in human
gene transfer trials
The National Institutes of Health (NIH) and the Food and Drug Administration
(FDA) announced today that they have launched a new Genetic Modification
Clinical Research Information System (GeMCRIS) a Web-accessible
database on human gene transfer. GeMCRIS, developed collaboratively
by the two agencies, is a unique public information resource as
well as an important new electronic tool to facilitate the reporting
and analysis of adverse events on these trials. The new system will
provide information to the public directly and will improve the
government's ability to monitor adverse events in gene transfer
research, also known as gene therapy.
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
NIH, FDA, and the research community to maintain appropriate oversight."
Acting FDA Commissioner Lester M. Crawford, D.V.M, Ph.D., emphasized
that "the development of GeMCRIS illustrates the government's
commitment to addressing public and patient concerns about safety
while advancing gene therapy. Providing accurate and complete information
about ongoing gene therapy studies is the best way to achieve this
GeMCRIS will enable patients, research participants, scientists,
sponsors, and the public at large to become better informed about
human gene transfer research. Through drop-down menus and preformatted
reports, individuals can easily navigate the GeMCRIS site to view
information on particular characteristics of clinical gene transfer
trials. For example, GeMCRIS users can learn where trials are taking
place, which diseases or health conditions are being studied, and
what investigational approaches are being taken. While offering
a rich array of information of value to many types of users, GeMCRIS
also includes special security features to protect patient privacy
and confidential commercial information.
Investigators and sponsors conducting human gene transfer trials
will now be able to report adverse events using a secure electronic
interface on the GeMCRIS system. With this tool, reports can be
submitted instantaneously to the NIH. Investigators and sponsors
can save their NIH submission on their own computer and send a copy
to the FDA in accordance with 21 CFR 312.32 together with a FDA
Form 1571. This can be done either by mailing or faxing a signed
hard copy or by making an electronic submission in accordance with
21 CFR 11. FDA Form 1571 can be found at http://forms.psc.gov/forms/FDA/fda.html.
Those submitting electronic documents should also refer to the Draft
Guidance for Industry: Providing Regulatory Submissions in Electronic
Format-General Consideration at http://www.fda.gov/cber/gdlns/elecgenrev1.htm
and related guidance at http://www.fda.gov/cber/esub/esubguid.htm.
Additional copies can be routed to Institutional Review Boards,
Institutional Biosafety Committees, Data Safety and Monitoring Boards,
and other local officials and review bodies as appropriate. The
electronic reporting tool is key to efforts by both agencies to
improve safety oversight and reporting in human gene transfer trials
through the harmonization of NIH and FDA reporting requirements.
The public GeMCRIS site is available at: http://www.gemcris.od.nih.gov/.
Investigators and sponsors who wish to use the system to report
adverse events occurring on human gene transfer trials should send
a written request on institutional letterhead by U.S. mail or fax
to: GeMCRIS Systems Administrator, NIH Office of Biotechnology Activities,
6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892; Fax:
The National Institutes of Health the Federal government's
focal point for medical research in the United States is
part of the U.S. Department of Health and Human Services.