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Public Law 110-85 which was enacted on September 27, 2007 amends the Public
Health Service Act to expand the scope of clinical trials to include both drug and device
trials that must be registered on ClinicalTrials.gov. It increased the number of data fields
that must be submitted, requires certain results information to be included and sets
penalties for noncompliance. The law specifies which studies need to be registered.
Additionally, effective July 1, 2008, ICMJE requires that all Phase I studies be registered
if consideration for publication is anticipated.
Instructional Information
Trials that must be registered are called “applicable clinical trials.”
These trials include:
Trials of Drugs and Biologics – controlled, clinical investigations, other than Phase I
investigations, of a product subject to FDA regulation (Phase II- IV trials now require
registration)
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.
Consistent with current FDA and ClinicalTrials.gov guidance, the NIH interprets
”serious and life-threatening disease or condition" to mean: (1) diseases or
conditions where the likelihood of death is high unless the course of the disease is
interrupted and (2) diseases or conditions with potentially fatal outcomes, where
the endpoint of clinical trial analysis is survival.
The seriousness of a disease is a matter of judgment, but generally is based on
such factors as survival, day-to-day functioning, and the likelihood that the disease,
if left untreated, will progress from a less severe condition to a more serious one.
For example, acquired immunodeficiency syndrome (AIDS), all other stages of human
immunodeficiency virus (HIV) infection, Alzheimer's disease, angina pectoris, heart
failure, cancer, and many other diseases are clearly serious in their full
manifestations. Furthermore, many chronic illnesses that are generally well managed
by available therapy can have serious outcomes. For example, inflammatory bowel
disease, asthma, rheumatoid arthritis, diabetes mellitus, systemic lupus
erythematosus, depression, psychoses, and many other diseases can be serious in
some or all of their phases or for certain populations.
Any investigational drug that has received fast track designation by the FDA is
considered a drug to treat a serious disease or condition.
Who is responsible for making sure this registration is performed?
Ultimately, it is the responsibility of the Principal Investigator. However, sponsors will many times perform the actual registration work for the PIs. Rather than assume
that this requirement has been fulfilled by the sponsor, it is best to ask prior to
enrollment of any subjects whether the clinical trial fully registered.
NIH-sponsored trials should be registered by the Institute that is funding the
research. The PI is responsible for initiating this registration with the agency.
Industry-sponsored trials (industry-written protocol) should be registered by the
sponsor. Contract language is included to specify that Sponsor will do this registration.
Investigator-initiated trials (for which industry has supplied drug or grant funds
should be registered by the PI.
Trials for which PIs hold their own INDs or IDEs should registered by the PI.
Multi-site trials should be coordinated among the sites and registered by the
“lead sponsor,” so that ClinicalTrials.gov does not receive multiple registrations for
the same trial.
