Announcement of a Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, 8096-8098 [2015-02994]
Download as PDF
8096
Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices
County noise thresholds. Furthermore,
any minor change in noise levels is not
expected to affect the character of the
site.
Air Quality
Traffic is expected to be the primary
mobile source of air emissions at or near
the campus. Mobile air emissions for the
campus at this time are expected to
originate from vehicles associated with
visitors, commuter transportation,
employee parking, commercial delivery,
and construction vehicles. Future traffic
generated carbon monoxide (CO)
concentrations were predicted to be less
than 2003 concentrations in the
Selected Alternative due to projected
vehicle emission rate reductions. Based
on predicted values, the one and eighthour average National Ambient Air
Quality Standards (NAAQS) CO
concentrations would not be exceeded
and no impacts are expected for any of
the proposed Alternatives.
tkelley on DSK3SPTVN1PROD with NOTICES
Wastewater/Water Supply
The Selected Alternative would
increase the amount of wastewater
generated on campus with the proposal
of additional development. To facilitate
the construction of the improvements
under this proposed alternative, the
existing wastewater distribution system
would need to be relocated and
upgraded as necessary. With the
increase in demand, NIH will consult
with the Washington Suburban Sanitary
Commission (WSSC) to ensure adequate
sewer capacity is available for the
campus. This consultation would also
assist WSSC in determining if and when
any of the public lines surrounding the
campus need to be upgraded. All
sanitary sewer design would be in
accordance with the NIH Facilities
Development Manual, ‘‘Section 8–6:
Drainage Systems’’ of the 2008 National
Institutes of Health Design
Requirements for Biomedical
Laboratories and Animal Research
Facilities and the WSSC requirements.
No significant impacts are expected for
wastewater or the NIH campus water
supply.
Historic Resources
NIH would comply with National
Historic Preservation Act (NHPA)
Section 106 by consulting with
Maryland Historical Trust (MHT) on the
need for particular archeological studies
as individual Master Plan project
elements are funded, designed, and
executed. In the event that eligible
prehistoric resources are identified and
adverse effects are anticipated, NIH
would continue Section 106
consultation with the appropriate
VerDate Sep<11>2014
21:56 Feb 12, 2015
Jkt 235001
consulting parties (which would
include MHT and may also include
Advisory Council on Historic
Preservation (ACHP) and Native
American tribes) to establish a
Memorandum of Agreement (MOA) to
resolve adverse effects. Mitigation
measures identified through this
consultation could include in-place
preservation through site avoidance,
protection, or easement acquisition;
development and implementation of a
data recovery plan to retrieve and
analyze the site’s resources
implementation of innovative,
alternative mitigation measures or a
combination of these measures.
Practicable Means To Avoid or
Minimize Potential Environmental
Harm From the Selected Alternative
All practicable means to avoid or
minimize adverse environmental effects
from the Selected Action have been
identified and incorporated into the
action. The proposed Master Plan
construction will be subject to the
existing NIH pollution prevention,
waste management, and safety, security,
and emergency response policies and
procedures as well as existing
environmental permits. Best
management practices, spill prevention
and control, and stormwater
management plans will be followed to
appropriately address the construction
and operation envisioned in [or
‘‘described in’’—the Master Plan itself
will not be constructed and operated] of
the new Master Plan and comply with
applicable regulatory and NIH
requirements. No additional mitigation
measures have been identified.
Pollution Prevention
Air quality permit standards will be
met, as will all federal, state, and local
requirements to protect the environment
and public health.
Conclusion
Based upon review and careful
consideration, the NIH has decided to
implement the Selected Alternative for
a long-range physical Master Plan for
NIH Bethesda Campus located in
Bethesda, Maryland. The decision
accounts for potential growth of NIH
personnel, and consequent construction
of space over the planning period. The
decision was based upon review and
careful consideration of the impacts
identified in the Final EIS and public
comments received throughout the
NEPA process.
Separate NEPA reviews, when
required, will be done on projects
discussed in the Master Plan. Proper
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
NEPA documentation will be completed
based on the outcome of that review.
Dated: February 5, 2015.
Daniel G. Wheeland, P.E.
Director, Office of Research Facilities
Development and Operations, National
Institutes of Health.
[FR Doc. 2015–02993 Filed 2–12–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Announcement of a Draft NIH Policy on
Dissemination of NIH-Funded Clinical
Trial Information
On November 19, 2014, the
National Institutes of Health (NIH)
published a request for public
comments in the NIH Guide for Grants
and Contracts on a draft policy to
promote broad and responsible
dissemination of information on clinical
trials funded by the NIH through
registration and submission of summary
results information to ClinicalTrials.gov.
See Guide notice NOT–OD–15–019 at
https://grants.nih.gov/grants/guide/
notice-files/NOT-OD-15-019.html. NIH
is publishing this notice in order to
inform readers of the Federal Register
about the draft policy and the
opportunity to comment.
DATES: The deadline for receiving
comments on the draft policy is no later
than 5:00 p.m. on March 23, 2015.
ADDRESSES: Comments may be
submitted by any of the following
methods:
• Email:
clinicaltrials.disseminationpolicy@
mail.nih.gov.
• Fax: 301–496–9839.
• Mail/Hand delivery/Courier: Office
of Clinical Research and Bioethics
Policy, Office of Science Policy,
National Institutes of Health, 6705
Rockledge Drive, Suite 750, Bethesda,
MD 20892.
FOR FURTHER INFORMATION CONTACT:
Office of Clinical Research and
Bioethics Policy, Office of Science
Policy, National Institutes of Health,
6705 Rockledge Drive, Suite 750,
Bethesda, MD 20892, 301–496–9838,
OCRBP-OSP@od.nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
The National Institutes of Health
(NIH) is dedicated to improving the
health of Americans by conducting and
funding biomedical and behavioral
E:\FR\FM\13FEN1.SGM
13FEN1
Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
research, including clinical trials.1 A
fundamental premise of all NIH-funded
research is that the results of such work
must be disseminated in order to
contribute to the general body of
scientific knowledge and, ultimately, to
the public health. NIH awardees are
expected to make the results and
accomplishments of their activities
available to the research community and
to the public at large.
The results of NIH funded research
can be disclosed in a number of ways,
including through publications,
presentations at scientific meetings,
sharing research tools, and depositing
information into databases and
materials into repositories. NIH has a
number of policies that promote the
dissemination of research results and
guide funding recipients in
disseminating their results. The NIH
Data Sharing Policy, the NIH Public
Access Policy, the NIH Research Tools
Policy, and the NIH Genomic Data
Sharing Policy are important examples
of policies to ensure that research data
and materials generated using NIH
funds are used productively to further
scientific progress and to promote
public health.2 Increasing public access
to information from NIH research
supports the public access and data
sharing directives of the Executive
Office of the President (EOP
Directives).3
Traditionally, scientists fulfill their
obligation to contribute to the general
body of knowledge through peer
reviewed journal publications.
However, journal publication is not
always possible, and many clinical trials
are not being published or published in
a timely manner. A recent study found
that the results of less than half of NIHfunded clinical trials had been
published in a peer-reviewed
biomedical journal within 30 months of
1 NIH’s mission is to seek fundamental knowledge
about the nature and behavior of living systems and
the application of that knowledge to enhance
health, lengthen life, and reduce illness and
disability. See https://www.nih.gov/about/
mission.htm.
2 See https://www.grants.nih.gov/grants/policy/
data_sharing/data_sharing_guidance.htm; https://
publicaccess.nih.gov/; https://grants.nih.gov/grants/
intell-property_64FR72090.pdf; and https://
gds.nih.gov/03policy2.html.
3 See the Office of Science and Technology
Policy’s memorandum, ‘‘Increasing Access to the
Results of Federally Funded Scientific Research,’’
(February 22, 2013), the Office of Management and
Budget’s memorandum, ‘‘Open Data Policy—
Managing Information as an Asset,’’ M–13–13 (May
9, 2013) https://www.whitehouse.gov/sites/default/
files/omb/memoranda/2013/m-13-13.pdf, and
Executive Order No. 13,642 (May 9, 2013) https://
www.gpo.gov/fdsys/pkg/DCPD-201300318/pdf/
DCPD-201300318.pdf.
VerDate Sep<11>2014
21:56 Feb 12, 2015
Jkt 235001
trial completion.4 Selective publication
of the results of some trials and not
others—or publication of incomplete or
partial findings from a particular trial—
can lead to inappropriate conclusions
about the usefulness of particular
therapies.5
Public access to clinical trial
information drives scientific progress
and optimizes the return on the nation’s
investment in clinical trials. It helps
inform future research, improve study
design, and prevent duplication of
unsafe and unsuccessful trials. In
addition, there is an important ethical
dimension to dissemination of clinical
trial results because individuals who
volunteer to participate in such studies,
and who may assume risks, trust that
what we learn will contribute to
generalizable knowledge about human
health. Finally, enhancing transparency
also increases public trust in clinical
research. It is, therefore, important to
provide other ways for clinical trial
results to be disseminated and publicly
available to researchers, health care
providers, and patient communities.
Some NIH-funded clinical trials are
subject to mandatory registration and
reporting of results under federal law,
i.e., Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA). FDAAA applies, in
general, to controlled, interventional
studies of Food and Drug
Administration (FDA)-regulated drugs,
biological products, and devices,
excluding phase 1 studies of drugs and
biological products and small feasibility
studies of devices. Under FDAAA, a
minimal set of summary information
about such clinical trials must be
submitted in a structured, tabular format
to ClinicalTrials.gov, a freely accessible
and searchable registry and results data
bank operated by the National Library of
Medicine (NLM), NIH.
NIH is proposing to issue a policy to
ensure that all NIH-funded clinical trials
are registered and have summary
results, including adverse event
information, submitted to
ClinicalTrials.gov. Compliance with this
policy will be a term and condition in
the Notice of Grant Award and a
4 Ross JS, Tse T, Zarin DA, Xu H, Zhou L,
Krumholz HM. Publication of NIH funded trials
registered in ClinicalTrials.gov: cross-sectional
analysis. BMJ. 2012;344:d7292.
5 Nissen S, Biomarkers in Cardiovascular
Medicine, The Shame of Publication Bias, JAMA
Intern Med 2013 March 25; doi:10.001/
jamainternmed.2013.4074; Dwan K et al.,
Systematic review of the empirical evidence of
study publication bias and outcome reporting bias,
PLoS One 2008 Aug 28;3(8):e3081. doi: 0.1371/
journal.pone.0003081; Begg C, Berlin J, Publication
bias and dissemination of clinical research, J Natl
Cancer Inst 1989, Jan 18;81(2):107–15.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
8097
contract requirement in the Contract
Award. This proposed policy supports
the NIH mission and is essential to
facilitate the translation of research
results into knowledge, products, and
procedures that improve human health.
Request for Comments
NIH encourages the public to provide
comments on any aspect of the draft
policy, described below. Comments
should be submitted electronically to
the Office of Clinical Research and
Bioethics Policy (OCRBP), Office of
Science Policy, NIH, via email at email
at clinicaltrials.disseminationpolicy@
mail.nih.gov, mail at 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892,
or by fax at 301–496–9839. Submitted
comments are considered public
information; private or confidential
information should not be submitted.
Comments may be posted along with the
submitter’s name and affiliation on the
OCRBP Web site after the public
comment period closes.
Draft NIH Policy on Dissemination of
NIH-Funded Clinical Trial Information
Purpose. The purpose of this Policy is
to promote broad and responsible
dissemination of information from NIHfunded clinical trials through
ClinicalTrials.gov, the clinical trial
registry and results databank operated
by the National Library of Medicine
(NLM). Disseminating this information
supports the NIH mission to advance
the translation of research results into
knowledge, products, and procedures
that improve human health. This Policy
is intended to complement the statutory
mandate under Title VIII of the Food
and Drug Administration Amendments
Act of 2007 (FDAAA) that requires
registration and submission of summary
results for certain clinical trials,
whether funded by NIH or by other
entities, to be registered and have
summary results submitted to
ClincalTrials.gov.6
Scope and Applicability. This Policy
applies to all NIH-funded awardees and
investigators conducting clinical trials,
funded in whole or in part by NIH,
regardless of study phase, type of
intervention, or whether they are subject
to the FDAAA registration and results
submission requirements set forth in
Section 402(j) of the Public Health
Service Act (42 U.S.C. 282(j)). For
6 The mandate applies to certain ‘‘applicable
clinical trials’’ (ACTs) of drugs (defined by section
402(j)(1)(A)(vii) of the Public Health Service Act to
include biological products) and devices, including
any pediatric postmarket surveillance of a device
required by FDA under section 522 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act). See 42
U.S.C. 282(j).
E:\FR\FM\13FEN1.SGM
13FEN1
8098
Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
purposes of this Policy, a clinical trial
is defined as ‘‘a research study in which
one or more human subjects are
prospectively assigned to one or more
interventions (which may include
placebo or other control) to evaluate the
effects of those interventions on healthrelated biomedical or behavioral
outcomes.7’’
Effective Date. This Policy is effective
for:
• Competing grant applications that
include clinical trials and are submitted
to the NIH for the [date to be
determined] receipt date and
subsequent receipt dates;
• Proposals for contracts that include
clinical trials and are submitted to the
NIH on or after [date to be determined];
and
• NIH intramural research projects
that include clinical trials for which
Institutional Review Board review is
initiated after [date to be determined].
Responsibilities. As set forth in the
terms and conditions of grant and
contract awards, all NIH-funded
awardees and investigators conducting
clinical trials, funded in whole or in
part by NIH, who have committed to
NIH that they will comply with NIH
policies, are expected to ensure that
their NIH-funded clinical trials are
registered and summary results,
including adverse event information, are
submitted to ClinicalTrials.gov in
7 Several terms within the NIH definition of
clinical trial definition mean are defined as follows.
‘‘Research’’ and ‘‘human subject’’ are defined in the
Common Rule at 45 CFR 46.102(d) and 45 CFR
46.102(f), respectively. ‘‘Prospectively assigned’’
refers to a pre-defined process (e.g., randomization)
specified in an approved protocol that stipulates the
assignment of research subjects (individually or in
clusters) to one or more arms (e.g., intervention,
placebo or other control) of the clinical trial. An
‘‘intervention’’ is defined as a manipulation of the
subject or subject’s environment for the purpose of
modifying one or more health-related biomedical or
behavioral processes and/or endpoints. Examples
include drugs/small molecules/compounds;
biologics; devices; procedures (e.g., surgical
techniques); delivery systems (e.g., telemedicine,
face-to-face interviews); strategies to change healthrelated behavior (e.g., diet, cognitive therapy,
exercise, development of new habits); treatment
strategies; prevention strategies; and, diagnostic
strategies. A ‘‘health-related biomedical or
behavioral outcome’’ is defined as the pre-specified
goal(s) or condition(s) that reflect the effect of one
or more interventions on human subjects’
biomedical or behavioral status or quality of life.
Examples include positive or negative changes to
physiological or biological parameters (e.g.,
improvement of lung capacity, gene expression);
positive or negative changes to psychological or
neurodevelopmental parameters (e.g., mood
management intervention for smokers; reading
comprehension and/or information retention);
positive or negative changes to disease processes;
positive or negative changes to health-related
behaviors; and, positive or negative changes to
quality of life. See https://osp.od.nih.gov/officeclinical-research-and-bioethics-policy/clinicalresearch-policy/clinical-trials>
VerDate Sep<11>2014
21:56 Feb 12, 2015
Jkt 235001
accord with the timelines that will be
set forth at ClinicalTrials.gov. Generally,
this means registration of the clinical
trial not later than 21 days after
enrollment of the first participant and
submission of summary results
information not later than one year after
the completion date. ‘‘Completion date’’
is defined to be the date that the final
subject was examined or received an
intervention for the purpose of final
collection of data for the primary
outcome, whether the clinical trial
concluded according to the prespecified protocol or was terminated. It
will be possible to delay results
submission for up to two years beyond
the initial deadline with a certification
that regulatory approval of the product
is being sought. Clinical trials covered
by the policy will be expected to submit
the same type of registration and results
data and in the same timeframes as the
trials subject to FDAAA. The specific
registration and results information to
be submitted will be made available at
the ClinicalTrials.gov site.
Institutions and investigators should
submit information directly to
ClinicalTrials.gov. If the trial is subject
to FDAAA, i.e., section 402(j) of the
Public Health Service Act (42 U.S.C.
282(j)), submissions must be made by
the Responsible Party, as defined at 42
U.S.C. 282(j)(1)(A)(ix). If an NIH-funded
clinical trial is also subject to FDAAA,
it needs to have only one entry in
ClinicalTrials.gov that contains its
registration and results information.
Investigators and funding recipients are
expected to cooperate with NLM to
address any data curation or quality
control issues to facilitate timely
posting.
In general, NIH expects to make
clinical trial registration and results
information publicly available through
ClinicalTrials.gov within 30 days after
receipt by ClinicalTrials.gov.8 For NIHfunded trials that are subject to section
402(j) of the Public Health Services Act
(42 U.S.C. 282(j)), submitted
information will be posted in
compliance with the relevant
requirements of that section.
Failure to comply with the terms and
conditions of NIH awards may provide
a basis for enforcement actions,
including termination, consistent with
8 For clinical trials funded through SBIRs, the
timeframe for posting results will be consistent with
the SBIR Policy Directive, which generally prohibits
the agency from posting SBIR data for at least 4
years from completion of the study unless the
awardee consents to an earlier release. See SBIR
Policy Directive, Sections 8(b)(2) and (4).
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
45 CFR 74.62 and/or other authorities,
as appropriate.9
Dated: January 8, 2015.
Lawrence Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2015–02994 Filed 2–12–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF THE INTERIOR
Office of the Secretary
[AAK6006201 1565A2100DD
AOR3030.999900]
National Environmental Policy Act:
Implementing Procedures; Additions
to Categorical Exclusions for Bureau
of Indian Affairs (516 DM 10)
Department of the Interior.
Notice of Final National
Environmental Policy Act Implementing
Procedures.
AGENCY:
ACTION:
In accordance with the
National Environmental Policy Act of
1969 (NEPA) and the Council on
Environmental Quality regulations
implementing NEPA, and Department of
the Interior (Department) NEPA
implementing regulations, the Bureau of
Indian Affairs (BIA) in the Department
is adding three categorical exclusions
(CE) to the Departmental Manual 516
DM 10. The three proposed CEs pertain
to timber harvesting on Indian lands.
DATES: Effective Date: The categorical
exclusions are effective February 13,
2015.
SUMMARY:
To obtain a copy of the new
categorical exclusions contact Mr. David
Koch, Acting Chief Forester, Bureau of
Indian Affairs, 1849 C Street,
Washington, DC 20240; email:
david.koch@bia.gov.
FOR FURTHER INFORMATION CONTACT: Mr.
David Koch, Acting Chief Forester, (202)
208–4837.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Background
Harvesting timber on Indian lands, as
defined in 25 CFR 163.1, allows
landowners to realize value from lands
held in trust for them by the Federal
Government or subject to restrictions
against alienation. The National Indian
Forest Resources Management Act, and
its implementing regulations, require
the Secretary, with the participation of
the landowners, to undertake forest land
management activities on Indian forest
9 When the final policy is issued, NIH will also
provide more specific procedural guidance to
facilitate implementation.
E:\FR\FM\13FEN1.SGM
13FEN1
Agencies
[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8096-8098]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Announcement of a Draft NIH Policy on Dissemination of NIH-Funded
Clinical Trial Information
SUMMARY: On November 19, 2014, the National Institutes of Health (NIH)
published a request for public comments in the NIH Guide for Grants and
Contracts on a draft policy to promote broad and responsible
dissemination of information on clinical trials funded by the NIH
through registration and submission of summary results information to
ClinicalTrials.gov. See Guide notice NOT-OD-15-019 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-019.html. NIH is
publishing this notice in order to inform readers of the Federal
Register about the draft policy and the opportunity to comment.
DATES: The deadline for receiving comments on the draft policy is no
later than 5:00 p.m. on March 23, 2015.
ADDRESSES: Comments may be submitted by any of the following methods:
Email: clinicaltrials.disseminationpolicy@mail.nih.gov.
Fax: 301-496-9839.
Mail/Hand delivery/Courier: Office of Clinical Research
and Bioethics Policy, Office of Science Policy, National Institutes of
Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892.
FOR FURTHER INFORMATION CONTACT: Office of Clinical Research and
Bioethics Policy, Office of Science Policy, National Institutes of
Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301-496-
9838, OCRBP-OSP@od.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
The National Institutes of Health (NIH) is dedicated to improving
the health of Americans by conducting and funding biomedical and
behavioral
[[Page 8097]]
research, including clinical trials.\1\ A fundamental premise of all
NIH-funded research is that the results of such work must be
disseminated in order to contribute to the general body of scientific
knowledge and, ultimately, to the public health. NIH awardees are
expected to make the results and accomplishments of their activities
available to the research community and to the public at large.
---------------------------------------------------------------------------
\1\ NIH's mission is to seek fundamental knowledge about the
nature and behavior of living systems and the application of that
knowledge to enhance health, lengthen life, and reduce illness and
disability. See https://www.nih.gov/about/mission.htm.
---------------------------------------------------------------------------
The results of NIH funded research can be disclosed in a number of
ways, including through publications, presentations at scientific
meetings, sharing research tools, and depositing information into
databases and materials into repositories. NIH has a number of policies
that promote the dissemination of research results and guide funding
recipients in disseminating their results. The NIH Data Sharing Policy,
the NIH Public Access Policy, the NIH Research Tools Policy, and the
NIH Genomic Data Sharing Policy are important examples of policies to
ensure that research data and materials generated using NIH funds are
used productively to further scientific progress and to promote public
health.\2\ Increasing public access to information from NIH research
supports the public access and data sharing directives of the Executive
Office of the President (EOP Directives).\3\
---------------------------------------------------------------------------
\2\ See https://www.grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm; https://publicaccess.nih.gov/; https://grants.nih.gov/grants/intell-property_64FR72090.pdf; and https://gds.nih.gov/03policy2.html.
\3\ See the Office of Science and Technology Policy's
memorandum, ``Increasing Access to the Results of Federally Funded
Scientific Research,'' (February 22, 2013), the Office of Management
and Budget's memorandum, ``Open Data Policy--Managing Information as
an Asset,'' M-13-13 (May 9, 2013) https://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-13.pdf, and Executive Order
No. 13,642 (May 9, 2013) https://www.gpo.gov/fdsys/pkg/DCPD-201300318/pdf/DCPD-201300318.pdf.
---------------------------------------------------------------------------
Traditionally, scientists fulfill their obligation to contribute to
the general body of knowledge through peer reviewed journal
publications. However, journal publication is not always possible, and
many clinical trials are not being published or published in a timely
manner. A recent study found that the results of less than half of NIH-
funded clinical trials had been published in a peer-reviewed biomedical
journal within 30 months of trial completion.\4\ Selective publication
of the results of some trials and not others--or publication of
incomplete or partial findings from a particular trial--can lead to
inappropriate conclusions about the usefulness of particular
therapies.\5\
---------------------------------------------------------------------------
\4\ Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM.
Publication of NIH funded trials registered in ClinicalTrials.gov:
cross-sectional analysis. BMJ. 2012;344:d7292.
\5\ Nissen S, Biomarkers in Cardiovascular Medicine, The Shame
of Publication Bias, JAMA Intern Med 2013 March 25; doi:10.001/
jamainternmed.2013.4074; Dwan K et al., Systematic review of the
empirical evidence of study publication bias and outcome reporting
bias, PLoS One 2008 Aug 28;3(8):e3081. doi: 0.1371/
journal.pone.0003081; Begg C, Berlin J, Publication bias and
dissemination of clinical research, J Natl Cancer Inst 1989, Jan
18;81(2):107-15.
---------------------------------------------------------------------------
Public access to clinical trial information drives scientific
progress and optimizes the return on the nation's investment in
clinical trials. It helps inform future research, improve study design,
and prevent duplication of unsafe and unsuccessful trials. In addition,
there is an important ethical dimension to dissemination of clinical
trial results because individuals who volunteer to participate in such
studies, and who may assume risks, trust that what we learn will
contribute to generalizable knowledge about human health. Finally,
enhancing transparency also increases public trust in clinical
research. It is, therefore, important to provide other ways for
clinical trial results to be disseminated and publicly available to
researchers, health care providers, and patient communities.
Some NIH-funded clinical trials are subject to mandatory
registration and reporting of results under federal law, i.e., Title
VIII of the Food and Drug Administration Amendments Act of 2007
(FDAAA). FDAAA applies, in general, to controlled, interventional
studies of Food and Drug Administration (FDA)-regulated drugs,
biological products, and devices, excluding phase 1 studies of drugs
and biological products and small feasibility studies of devices. Under
FDAAA, a minimal set of summary information about such clinical trials
must be submitted in a structured, tabular format to
ClinicalTrials.gov, a freely accessible and searchable registry and
results data bank operated by the National Library of Medicine (NLM),
NIH.
NIH is proposing to issue a policy to ensure that all NIH-funded
clinical trials are registered and have summary results, including
adverse event information, submitted to ClinicalTrials.gov. Compliance
with this policy will be a term and condition in the Notice of Grant
Award and a contract requirement in the Contract Award. This proposed
policy supports the NIH mission and is essential to facilitate the
translation of research results into knowledge, products, and
procedures that improve human health.
Request for Comments
NIH encourages the public to provide comments on any aspect of the
draft policy, described below. Comments should be submitted
electronically to the Office of Clinical Research and Bioethics Policy
(OCRBP), Office of Science Policy, NIH, via email at email at
clinicaltrials.disseminationpolicy@mail.nih.gov, mail at 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892, or by fax at 301-496-9839.
Submitted comments are considered public information; private or
confidential information should not be submitted. Comments may be
posted along with the submitter's name and affiliation on the OCRBP Web
site after the public comment period closes.
Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial
Information
Purpose. The purpose of this Policy is to promote broad and
responsible dissemination of information from NIH-funded clinical
trials through ClinicalTrials.gov, the clinical trial registry and
results databank operated by the National Library of Medicine (NLM).
Disseminating this information supports the NIH mission to advance the
translation of research results into knowledge, products, and
procedures that improve human health. This Policy is intended to
complement the statutory mandate under Title VIII of the Food and Drug
Administration Amendments Act of 2007 (FDAAA) that requires
registration and submission of summary results for certain clinical
trials, whether funded by NIH or by other entities, to be registered
and have summary results submitted to ClincalTrials.gov.\6\
---------------------------------------------------------------------------
\6\ The mandate applies to certain ``applicable clinical
trials'' (ACTs) of drugs (defined by section 402(j)(1)(A)(vii) of
the Public Health Service Act to include biological products) and
devices, including any pediatric postmarket surveillance of a device
required by FDA under section 522 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act). See 42 U.S.C. 282(j).
---------------------------------------------------------------------------
Scope and Applicability. This Policy applies to all NIH-funded
awardees and investigators conducting clinical trials, funded in whole
or in part by NIH, regardless of study phase, type of intervention, or
whether they are subject to the FDAAA registration and results
submission requirements set forth in Section 402(j) of the Public
Health Service Act (42 U.S.C. 282(j)). For
[[Page 8098]]
purposes of this Policy, a clinical trial is defined as ``a research
study in which one or more human subjects are prospectively assigned to
one or more interventions (which may include placebo or other control)
to evaluate the effects of those interventions on health-related
biomedical or behavioral outcomes.\7\''
---------------------------------------------------------------------------
\7\ Several terms within the NIH definition of clinical trial
definition mean are defined as follows. ``Research'' and ``human
subject'' are defined in the Common Rule at 45 CFR 46.102(d) and 45
CFR 46.102(f), respectively. ``Prospectively assigned'' refers to a
pre-defined process (e.g., randomization) specified in an approved
protocol that stipulates the assignment of research subjects
(individually or in clusters) to one or more arms (e.g.,
intervention, placebo or other control) of the clinical trial. An
``intervention'' is defined as a manipulation of the subject or
subject's environment for the purpose of modifying one or more
health-related biomedical or behavioral processes and/or endpoints.
Examples include drugs/small molecules/compounds; biologics;
devices; procedures (e.g., surgical techniques); delivery systems
(e.g., telemedicine, face-to-face interviews); strategies to change
health-related behavior (e.g., diet, cognitive therapy, exercise,
development of new habits); treatment strategies; prevention
strategies; and, diagnostic strategies. A ``health-related
biomedical or behavioral outcome'' is defined as the pre-specified
goal(s) or condition(s) that reflect the effect of one or more
interventions on human subjects' biomedical or behavioral status or
quality of life. Examples include positive or negative changes to
physiological or biological parameters (e.g., improvement of lung
capacity, gene expression); positive or negative changes to
psychological or neurodevelopmental parameters (e.g., mood
management intervention for smokers; reading comprehension and/or
information retention); positive or negative changes to disease
processes; positive or negative changes to health-related behaviors;
and, positive or negative changes to quality of life. See https://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials>
---------------------------------------------------------------------------
Effective Date. This Policy is effective for:
Competing grant applications that include clinical trials
and are submitted to the NIH for the [date to be determined] receipt
date and subsequent receipt dates;
Proposals for contracts that include clinical trials and
are submitted to the NIH on or after [date to be determined]; and
NIH intramural research projects that include clinical
trials for which Institutional Review Board review is initiated after
[date to be determined].
Responsibilities. As set forth in the terms and conditions of grant
and contract awards, all NIH-funded awardees and investigators
conducting clinical trials, funded in whole or in part by NIH, who have
committed to NIH that they will comply with NIH policies, are expected
to ensure that their NIH-funded clinical trials are registered and
summary results, including adverse event information, are submitted to
ClinicalTrials.gov in accord with the timelines that will be set forth
at ClinicalTrials.gov. Generally, this means registration of the
clinical trial not later than 21 days after enrollment of the first
participant and submission of summary results information not later
than one year after the completion date. ``Completion date'' is defined
to be the date that the final subject was examined or received an
intervention for the purpose of final collection of data for the
primary outcome, whether the clinical trial concluded according to the
pre-specified protocol or was terminated. It will be possible to delay
results submission for up to two years beyond the initial deadline with
a certification that regulatory approval of the product is being
sought. Clinical trials covered by the policy will be expected to
submit the same type of registration and results data and in the same
timeframes as the trials subject to FDAAA. The specific registration
and results information to be submitted will be made available at the
ClinicalTrials.gov site.
Institutions and investigators should submit information directly
to ClinicalTrials.gov. If the trial is subject to FDAAA, i.e., section
402(j) of the Public Health Service Act (42 U.S.C. 282(j)), submissions
must be made by the Responsible Party, as defined at 42 U.S.C.
282(j)(1)(A)(ix). If an NIH-funded clinical trial is also subject to
FDAAA, it needs to have only one entry in ClinicalTrials.gov that
contains its registration and results information. Investigators and
funding recipients are expected to cooperate with NLM to address any
data curation or quality control issues to facilitate timely posting.
In general, NIH expects to make clinical trial registration and
results information publicly available through ClinicalTrials.gov
within 30 days after receipt by ClinicalTrials.gov.\8\ For NIH-funded
trials that are subject to section 402(j) of the Public Health Services
Act (42 U.S.C. 282(j)), submitted information will be posted in
compliance with the relevant requirements of that section.
---------------------------------------------------------------------------
\8\ For clinical trials funded through SBIRs, the timeframe for
posting results will be consistent with the SBIR Policy Directive,
which generally prohibits the agency from posting SBIR data for at
least 4 years from completion of the study unless the awardee
consents to an earlier release. See SBIR Policy Directive, Sections
8(b)(2) and (4).
---------------------------------------------------------------------------
Failure to comply with the terms and conditions of NIH awards may
provide a basis for enforcement actions, including termination,
consistent with 45 CFR 74.62 and/or other authorities, as
appropriate.\9\
---------------------------------------------------------------------------
\9\ When the final policy is issued, NIH will also provide more
specific procedural guidance to facilitate implementation.
Dated: January 8, 2015.
Lawrence Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2015-02994 Filed 2-12-15; 8:45 am]
BILLING CODE 4140-01-P