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Clinical Trials Registration
There
is some confusion regarding registration of clinical trials.
One reason for this confusion is the fact that there are
at least two different recent sets of clinical trial registration
requirements that may be relevant to you as an investigator.
The FDA and the International Committee of Medical Journal
Editors (ICMJE) each have their own registration requirements.
While some of the requirements overlap, there are also
significant differences. In order to comply with new laws
and preserve the ability to publish in ICMJE journals
both sets of requirements must
be met.
FDA Clinical Trials Registration:
The
1997 FDA Modernization Act (FDAMA) required the registration
of trials testing drugs for life threatening diseases
and conditions. This requirement led to the creation of
ClinicalTrials.gov which is administrated by the National
Library of Medicine.
What has changed with the FDA Registration?
In September 2007, the FDA Amendment Act expanded the
current ClinicalTrials.gov requirements.
- It
expands the types of trials that must be registered
to all clinical trials for drugs, devices, and biologics
with the exception of Phase I drug trials and small
device feasibility studies.
-
Remember that the previous required registration
was limited to drug trials for life-threatening diseases
or conditions..
-
It increases the data elements that must be included
in the registration
-
Within three years, the results of trials must
be registered upon the completion of the primary aim
of the study. The logistics for the registration of
results have not yet been developed.
ICMJE Clinical Trials Registration:
On
June 9, 2005, the International Committee of Journal Medical
Editors (ICMJE)* made registration of phase 2 and beyond
clinical trials a condition for publication in any of
their journals. Their definition of clinical trial is:
-
Any human research project that prospectively assigns
human subjects to an intervention or comparison group
to study the relationship between a medical intervention
and a health outcome
-
Note:
A medical intervention could be a procedure, including
talk therapy or other similar psychiatric interventions.
*
ICMJE Signatories: New England Journal of Medicine,
Journal of the American Medical Association, Annals
of Internal Medicine, The Lancet, The Medical Journal
of Australia, The New Zealand Medical Journal, Norwegian
Medical Journal, Canadian Medical Association Journal,
Croation Medical Journal, Dutch Journal of Medicine,
Journal of the Danish Medical Association.
What
has changed with the ICJME Registration?
Effective July 1, 2008. the ICMJE is requiring the registration
of all clinical trials including Phase I and pharmaco-kinetic
trials.
Updating Registrations:
Once a trial is registered, both the FDA and the ICMJE
require that registrations be updated as follows:
FDA
updating requirements:
-
Information must be updated at least every 12 months
-
Additionally the registry must be updated within 30
days of any changes in recruitment status or completion
of study
ICMJE
requires updating study information every six months
Who
is responsible for registration?
For FDA Registration:
The sponsor of the drug or device clinical trial, as defined/identified
under the FDA regulations, is responsible for registering
the trial. This could be either the company or the investigator.
If
the sponsor is the company, the company at its discretion,
can delegate the principal investigator as the “responsible
party.” This may only be done when “the principal investigator
is responsible for conducting the trial, has access
to and control over the data from the clinical trial,
has the right to publish the results of the trial, and
has the ability to meet all of the requirements” for
submitting information under the law.
For
ICMJE Registration:
While anyone involved in the clinical trial could register
the trial, in practice this responsibility usually falls
with the individual submitting the publication to the
ICMJE journal, which is usually the Principal Investigator.
What is the deadline for registration?
N.b.,
Compliance with the ICMJE is only required if publication
in one of the relevant journals is planned. In contrast,
compliance with the FDA regulations is required for relevant
trials. If there is any possibility of submission to an
ICMJE journal for publication, we suggest compliance with
both registration requirements.
Compliance
with the new FDA law of 2007 requires completing
registration of the following by December 26, 2007.
Phase
2 and beyond drug/biologic and device trials that are
initiated after 9/27/2007 or that are ongoing as of
12/26/2007 must be registered in full. This includes:
Registration
of trials that have not previously been registered AND
Update
of ongoing clinical trials that have previously been
registered (Ongoing is defined as 1 or more subjects
enrolled and the completion date has not been reached).
Registration
for a new study is required within 21 days after enrolling
the first subject (FDA)
Compliance
with the ICMJE requires the following registration
by July 1, 2008:
All phases of any human research project that prospectively
assigns human subjects to an intervention or comparison
group to study the relationship between a medical intervention
and a health outcome.
Registration
is required before the first subject is enrolled (ICMJE)
Registering your study:
You must work through our “institutional account”. Do
not go directly to ClinicalTrials.gov, they will simply
send you back to us.
To start this process, contact the PHRC
registration administrator
Provide
the Administrator with the following information:
Partners log-in ID [username only]
Full Name
Home Institution
Partners Email Address
The
Administrator will enter this information into the ClinicalTrials.gov
website
and thus create a “profile” for the Investigator. The
ClinicalTrials.gov website sends confirmation to the investigator
regarding his/her ability to sign onto the website and
begin the registration process. For further details, see
FAQs
on Clinical Trial Registration.
The investigator can then enter the study registration
information. An email will
be automatically sent to the Administrator, who will “release”
the registration to
the website.
If ClinicalTrials.gov has any questions related to the
study or information about
the study - their query will be sent directly to the investigator (or designee).
For questions call/contact:
Deb Barnard at 617-424-4171 or dbarnard@partners.org
Vicki
Mirabello at 617-424-4140 or vmirabello@partners.org |