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In 2005, the
International Committee of Medical Journal Editors (ICMJE) first
initiated a policy whereby they will consider a trial for
publication only if it has been registered before the
enrollment of the first patient. Since implementation of this
initial policy, registration and subsequent posting of study
results on ClinicalTrials.gov has escalated. In addition to the
ICMJE policy, the Food and Drug Administration Amendments Act of
2007 (FDAAA) legislation
U.S. Public Law 110-085 expands clinical trial registry
requirements. The NIH Guidance document
below outlines application, scope and responsibility of trial
registration under the FDAAA. In addition, information is
provided regarding obtaining an access code to register trials
under the UK Organizational Account.
 International
Committee of Medical Journal Editors (ICMJE) Publication
Requirement
Food
and Drug Administration Amendments Act of 2007 (FDAAA)
TITLE VIII—Clinical Trial Databases
U.S. Public Law 110-085
Guidance
on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration
FAQs
- Clinical Trials Registration in ClinicalTrials.gov
Association
of American Medical Colleges Action Memo Re Clinical Trials
Education Requirement 11/19/07
ClinicalTrails.gov
Data Element Definitions
ClinicalTrials.gov
Access Code
to register trials under the UK Organizational Account
World
Health Organization (WHO), through the WHO International
Clinical Trials Registry Platform (ICTRP).
Physician Data
Query (PDQ®) Cancer Clinical Trials Registry and
ClinicalTrials.gov coordination International Committee of
Medical Journal Editors (ICMJE) Publication Requirement
2007 Update on ICMJE registration policy
Key Summary
Points
In addition to
accepting registration in any of the 5 existing registries, the
ICMJE will accept registration of clinical trials in any of the
primary registers that participate in the WHO ICTRP.
Registration in a partner register only is insufficient.
The ICMJE will
begin to implement the WHO definition of clinical trials for all
trials that begin enrollment on or after 1 July 2008. This
definition states that a clinical trial is “any research study
that prospectively assigns human participants or groups of
humans to one or more health-related interventions to evaluate
the effects on health outcomes.”
Food and Drug Administration Amendments Act of 2007 (FDAAA)
TITLE VIII—CLINICAL TRIAL DATABASES
U.S. Public Law 110-085
Current federal law requires the
registration of clinical trials only for drugs intended for the
treatment of serious or life-threatening diseases or conditions.
Title VIII
mandates the expansion of clinical trial registry data banks in
regard to the data elements, linking data banks with results and
sanctions for non-compliance or submission of false or
misleading information.
Guidance on
New Law (Public Law 110-85) Enacted to Expand the Scope of
ClinicalTrials.gov: Registration
Notice Number:
NOT-OD-08-014
Key Dates
Release Date: November 16, 2007
Issued by
National Institutes of Health (NIH), (http://www.nih.gov)
A new law has
been enacted to expand the scope of ClinicalTrials.gov. This
notice provides information for NIH grantees on new
responsibilities related to the first part of the law, the
registration of clinical trials.
New Law
Enacted to Expand ClinicalTrials.gov:
Public Law
110-85, which was enacted on September 27, 2007 [http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf]
amends the Public Health Service Act to expand the scope of
clinical trials that must be registered in ClinicalTrials.gov.
It also increases the number of registration fields that must be
submitted, requires certain results information to be included
and sets penalties for noncompliance. This notice provides
information for NIH grantees and contractors on new
responsibilities related to the first part of the law, the
registration of clinical trials. Additional information will
be forthcoming.
Which
Trials Must be Registered?
The trials that
must be registered are called “applicable clinical trials.”
Under the statute, 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 postmarket surveillance. You
should review the statutory definition of applicable clinical
trial to identify if any of your trials must be registered to
comply with the law [http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf
] See PL 110-85, Section 801(a), (adding new 42 U.S.C.
282(j)(1)(A)). 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) [
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2003/aprqtr/pdf/21cfr50.3.pdf
], or
(2) the principal investigator of such clinical trial if so
designated by a sponsor, grantee, contractor, or awardee
(provided that “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.)
[http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf]
See PL 110-85, Section 801(a), (adding new 42 U.S.C.
282(j)(1)(A)(ix)).
How do you determine if you are a responsible party?
Investigators are encouraged to consult with their sponsored
research office, institutional counsel, or other partners to
determine if they are the “responsible party” for registering a
trial. It is your responsibility to determine if you are
obligated to register any of your clinical trials.
1) If you are the Investigational New Drug Application (IND) or
Investigational Device Exemption (IDE) holder, you may be the
“sponsor” as that term is defined in the FDA regulations found
at 21 C.F.R. 50.3. For studies that are conducted under an IND
or IDE, the “sponsor” is identified in the course of filing the
IND (commonly called the “IND holder” or the “part 812 sponsor”)
OR
2) You may not be the sponsor, but if you are the Principal
Investigator you may have been delegated registration duties by
the sponsor provided the other conditions for access and control
over information are met. OR
3) For extramural trials, where there is no IND or IDE holder,
NIH would not be the responsible party. The funding recipient
may be a “responsible party” as that term is defined in the Act,
depending on the unique circumstances of the trial.
When Must I Register My Trial?
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 or 21 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.
(“Ongoing” in
this context means a trial had one or more patients enrolled,
but had not examined the final subject or provided the final
subject an intervention for the purposes of final collection of
data for the primary outcome as of 9/27/2007.)
What are the penalties for failing to register an “applicable
clinical trial?”
Penalties for responsible parties who fail to register, or
provide false or misleading information in connection with,
applicable clinical trials are significant and may include
civil monetary penalties and, for federally-funded trials, the
withholding or recovery of grant funds. See PL 110-85,
Sections 801(a), (b), (adding new 42 U.S.C. 282(j), and new 21
U.S.C. 331(jj)).
Obtaining
Assistance from NIH:
Existing
mechanisms established by NIH ICs to assist funding recipients
in registering trials with ClinicalTrials.gov can continue to be
used to assist responsible parties with the new registration
requirements. A list of IC liaisons is provided below. While
the NIH anticipates the continuation of this service, it is
important to remember that the IC cannot in any way substitute
for the responsible party in fulfilling its statutory duties.
When requesting registration assistance from an IC, you are
responsible for ensuring that all necessary information is
provided to the IC in sufficient time to review and coordinate
before the statutory deadlines described above for submission to
ClinicalTrials.gov are triggered. You will need to stay in
contact with the IC liaison to ensure that your information has
been registered properly. Submission of registration
information to an IC is not sufficient to satisfy the statutory
obligations for submission to ClinicalTrials.gov.
Alternatively, you may register your trial directly by following
the procedures outlined at
http://prsinfo.clinicaltrials.gov/.
ClinicalTrials.gov Access
ClinicalTrials.gov is in the process of making updates to the
Protocol Registration System (PRS) based on this legislation
Additional information on the new registration requirements is
available on the PRS Web site
http://prsinfo.clinicaltrials.gov/.
To obtain an
access code to the UK Organizational Account on
ClinicalTrials.gov, send a request with Name Department and
Email address to:
Once you receive the user login and default password
you will need to log in and change password:
Click [Change password] on the
Main Menu.
Enter:
Organization - UKentucky
User Login -
Password -
-
old password
-
new password
-
new password again for verification
Click [Change Password] to save the
new password. Remember your login and password. Contact your
Administrator if you forget your password.
Where can I
get a template of the information required for registration at
ClinicalTrials.gov?
You may
visit the clinicaltrials.gov website for a tour of the form
http://prsinfo.clinicaltrials.gov/intro.html or to see a
sample protocol records
http://prsinfo.clinicaltrials.gov/editProtocol.html
Who can I
contact at UK with questions about investigator-initiated
research?
William
Balke, MD
Sr. Associate Dean for Research
The University of Kentucky
College of Medicine
MN 150 Chandler Medical Center
Email:
b.balke@uky.edu
World Health Organization (WHO), through the WHO
International Clinical Trials Registry Platform (ICTRP).
The WHO has
made efforts to develop a coordinated process for identifying,
gathering, and searching trials from registries around the world
via an
International Clinical Trial Registry Platform Search Portal.
Once a trial is registered, full transparency and
accountability requires that all of the trial's results be made
available to the public in a timely manner.
PDQ &
Clinicaltrials.gov
Physician Data Query (PDQ®) Cancer Clinical
Trials Registry, has also become an
active participant in the worldwide clinical trials registration
movement. PDQ works with ClinicalTrials.gov to ensure that
NCI-sponsored trials are registered in that registry in
compliance with ICMJE requirements.
To help ensure
the comprehensiveness of the registry,
PDQ and NIH's
ClinicalTrials.gov database
regularly exchange clinical trial information.
Cancer trials registered in PDQ will
automatically be registered in ClinicalTrials.gov and vice
versa.
Protocol
abstracts in PDQ are written in two formats, the health
professional abstract (uses technical terminology) and the
patient abstract (uses non-technical language). However, some
trials (obtained from
ClinicalTrials.gov) contain the same text in both the
patient and health professional abstracts.
Searching
for clinical trials
NCI's PDQ
clinical trials registry can be searched using a
basic search form that allows selection of a type of cancer,
stage/subtype, type of trial, and location. It is also possible
to search for trials using additional criteria such as type of
treatment/intervention, drug name, phase of trial, or a
combination of these and other variables by using an
advanced search form. Help links at the top of each clinical
trials search form lead to more information and tips about
searching for clinical trials.
Registering
clinical trials with PDQ
Submission Instructions
and a
portal for online submission of protocols to PDQ are
available on NCI's Web site.
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