| NHLBI
Research and Policy Update
Number 60s
Special January 22, 2009 Supplement
Reporting
Clinical Trial Results to ClinicalTrials.gov
This section
provides information on who may be responsible for submitting clinical
trial summary results to ClinicalTrials.gov, what type of trials must be
reported, and how to report the results.
U.S.
Public Law 110-85 [PDF: 156 pages] (Food and Drug Administration Amendments
Act of 2007 or FDAAA), Title VIII, Section 801 mandates that a "responsible
party" (i.e., the sponsor or designated principal investigator) register
and report results of certain "applicable clinical trials." It
is important for investigators to determine whether they are subject to
the law and, if so, to be sure that they have carried out their responsibilities
for submitting summary results from the trial. Failure to comply with Title
VIII of FDAAA can result in civil penalties, including the withdrawal of
NIH funding.
"Applicable clinical trials" generally include:
- Trials
of Drugs and Biologics: Controlled, clinical investigations,
other than Phase I investigations, of a product subject to FDA
regulation;
- Trials
of Devices: Controlled trials with health outcomes of
a product subject to FDA regulation (other than small feasibility
studies) and pediatric postmarket surveillance studies.
In other words, "applicable
clinical trials" include interventional studies (with one or more
arms) of drugs, biological products, or devices that are subject to FDA
regulation, meaning that the trial has one or more sites in the U.S, involves
a drug, biologic, or device that is manufactured in the US (or its territories),
or is conducted under an investigational new drug application (IND). Complete
statutory definitions and more
detailed information on the agency's current thinking [PDF: 9 pages] about
their meaning are available.
To gain a better understanding of what will be involved in reporting summary
results; responsible parties are encouraged to review the documents under
“Basic Results Database” at http://prsinfo.clinicaltrials.gov/fdaaa.html.
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