News
ClinicalTrials.gov
- Protocol
Registration System
A
new law has been enacted to expand the scope of ClinicalTrials.gov.
Public Law 110-85, enacted on September 27, 2007, amends the Public
Health Service Act to expand the scope of clinical trials that must
be registered in ClinicalTrials.gov.
All
"applicable clinical trials", these trials generally include:
(1) Trials of Drugs and Biologics : Controlled,
clinical investigations, other than Phase 1 investigations, of a
product subject to FDA regulation; and (2) Trials of Devices
: Controlled trials with health outcomes, other than
small feasibility studies, and pediatric post-market surveillance.
NIH encourages registration of ALL trials whether required under
the law or not.
Who
is responsible?
The entity responsible for registering is the "responsible party."
The statute defines the responsible party as:
(1) the sponsor of the clinical trial (as defined in 21 C.F.R. 50.3)
or
(2) the principal investigator of such clinical trial if so designated
by a sponsor, grantee, contractor, or awardee
When should trials be registered?
1) Trials initiated after 9/27/2007, or trials that are ongoing
as of 12/26/2007 must be registered in full by: The later
of 12/26/ 2007 or21 days after the first patient
is enrolled.
2)
Trials that were "ongoing" as of as of 9/27/2007 and do not
involve a "serious or life threatening disease or
condition," must be registered by 9/27/ 2008 .
3)
Trials that were "ongoing" as of as of 9/27/2007, do involve a "serious
or life threatening disease or condition," and are completed (meaning,
not "ongoing") by 12/26/2007 are not subject to these requirements,
though they may be subject to pre-existing registering requirements.
For
more information, see
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html
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