and Human Services (HHS)
EXPIRED
NIH CLINICAL TRIAL PLANNING GRANT (R34) PROGRAM
RELEASE DATE: October 16, 2003
PA NUMBER: PA-04-008 (NCCAM no longer participating in this announcement,
see NOT-AT-05-006)
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date. The
non-AIDS portion of this funding opportunity expires on the date indicated below.
A replacement R34 (PA-06-363) funding opportunity announcement has been issued
for the submission date of June 1, 2006 and submission dates for AIDS and
non-AIDS applications thereafter.
EXPIRATION DATE for R34 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R34 AIDS and AIDS-Related Applications: May 2, 2006
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute on Aging (NIA)
(http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
(http://www.niams.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov/)
Office of Research on Women's Health (ORWH)
(http://www4.od.nih.gov/orwh/index.html)
Office of Behavioral and Social Sciences Research (OBSSR)
(http://obssr.od.nih.gov/)
Office of Rare Diseases (ORD)
(http://rarediseases.info.nih.gov/)
Office of Dietary Supplements (ODS)
(http://dietary-supplements.info.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.173, 93.209, 93.213,
93.271, 93.272, 93.273, 93.277, 93.278, 93.279, 93.846, 93.853, 93.864,
93.865, 93.866, 93.891
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The purpose of the NIH Clinical Trial Planning Grant (R34) is to provide
support for the development of a Phase III clinical trial, including the
establishment of the research team, the development of tools for data
management and oversight of the research, the definition of recruitment
strategies, and the finalization of the protocol and other essential elements
of the study included in a manual of operations/procedures. The Clinical
Trial Planning Grant is not designed for the collection of preliminary data
or the conduct of pilot studies to support the rationale for a clinical
trial.
An NIH-defined Phase III clinical trial is a broadly based prospective
clinical investigation, usually involving several hundred or more human
subjects, for the purpose of evaluating an experimental intervention in
comparison with a standard or control intervention or comparing two or more
existing treatments. Often, the aim of such investigation is to provide
evidence leading to a scientific basis for consideration of a change in
health policy or standard of care. The definition includes pharmacologic,
non-pharmacologic, and behavioral interventions for disease prevention,
prophylaxis, diagnosis or therapy. Community- and other population-based
intervention trials also are included.
The planning grant is designed to permit early peer review of the rationale
and design of the proposed clinical trial and to provide support for the
development of a detailed Manual of Procedures (MOP) including all elements
essential to the launching of a trial.
Investigators wishing to apply for an R34 grant should be aware that
individual ICs may have specific requirements for this funding mechanism and,
therefore, should consult IC staff to determine if an application is
appropriate. NIH Offices that participate in this PA (ORWH, OBSSR, ORD, ODS)
are listed but do not have funding authority and must work through an
Institute or Center.
RESEARCH OBJECTIVES
Background
At the time of submission, applications requesting support for Phase III
clinical trials are expected to provide detailed information regarding the
study's rationale, design, analytic techniques, protocols and procedures,
facilities and environment, organizational structure, and collaborative
arrangements. This information is best conveyed in a well-documented Manual
of Procedures (MOP), the development of which typically represents a costly
and time-consuming activity. Delay of the trial caused by the need to
develop a MOP reduces the time available to carry out the trial itself. The
R34 has been established to allow for the planning and organizational
activities necessary to implement a Phase III clinical trial to take place
well in advance of funding of the actual trial.
Scope
The planning grant is designed to: (1) permit early peer review of the
rationale for the proposed clinical trial; (2) permit assessment of the
design/protocol of the proposed trial in its current, early form; (3) provide
support for the development of a detailed MOP; and (4) support the
development of other essential elements of a clinical trial as defined by the
individual participating ICs.
Activities supported by the R34 may include, but are not limited to, the
following examples:
o developing/finalizing the Manual of Operations; basic elements in the MOP
should include identification of the patient population; inclusion and
exclusion criteria; adequate plans for recruitment and retention of
participants; experimental design and protocols; clear definition of the
research hypothesis and outcome measures; quality control/assurance
procedures; data management and analytical techniques; sample size estimates
with justification; administrative procedures (including regulatory approvals
if necessary); collaborative arrangements; duties and responsibilities of
study chairperson, clinical sites, coordinating center, and other central
resources such as a central laboratory; and monitoring plans to assure
patient protection and data integrity;
o finalizing plans for addressing Federal and NIH gender/minority inclusion
and human subjects protection requirements;
o establishing collaborative arrangements;
o instituting means to assure standardization of procedures across sites and
among staff;
o developing tools needed for data collection and data management;
o developing/finalizing safety and monitoring plans; in the application, do
not name individuals for the Data and Safety Monitoring Board (DSMB), but
include areas of expertise that will be tapped in forming the DSMB; contact
the relevant IC for specific DSMB policies;
o developing plans for any training that may be required to carry out the
proposed trial, including, for example, training of data collectors and
individuals who will carry out the planned intervention.
Please note that an IC may support any or all of these activities; see
http://grants.nih.gov/grants/funding/r34.htm for contact information and
specific IC requirements regarding the content and format of a MOP.
The Clinical Trial Planning Grant is not designed for the collection of
preliminary data or the conduct of pilot studies to support the rationale for
a clinical trial. Consider other funding mechanisms to support pilot or
feasibility studies; IC staff should be consulted for guidance.
It is expected that receipt of an R34 grant will lead to the timely
submission of an application for support of the full-scale trial,
incorporating the elements developed under the planning grant. Prospective
applicants should note that funding of a Clinical Trial Planning Grant does
not guarantee or imply funding for a subsequent application.
MECHANISM OF SUPPORT
This PA will use the NIH Clinical Trial Planning Grant (R34) award mechanism.
As an applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
You may request a project period of one year and a budget for direct costs of
up to four $25,000 modules or $100,000 per year.
This PA uses just-in-time concepts. It also uses the modular budgeting
format (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular format. This program does not
require cost sharing as defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
Planning Grant support is for new projects only; competing continuation
applications will not be accepted.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Minimum Application Requirements
Future Clinical Trial:
o Rationale/Significance - Provide the rationale for the future clinical
trial, documenting the significance and need to perform the trial. Describe
the potential impact of the clinical trial on health care, policy or
practice.
o Research Design and Methods - Enough information should be provided to
allow reviewers to evaluate how the trial would be conducted.
o Inclusion and Human Subjects Issues The application must address the
availability and population description of the requisite patient population
and plans for recruitment outreach and follow-up. In addition, plans for
addressing issues and challenges regarding adherence to the proposed
intervention protocol should be included.
Planning Period Activities:
o Justification for the Planning Grant Explain the need for the planning
grant. Describe the anticipated advantages to beginning the proposed RCT
after planning period support as contrasted to beginning the trial without
such support.
o Investigators - The application must include a description of the
leadership and proposed organization of the clinical trial, including
proposed clinical sites (letters of commitment are not required at this
stage). This includes the ability of the Principal Investigator to bring
together the necessary trial network. Describe the mechanism for
identification and selection of additional collaborators. Describe the
participants in the planning process, their roles in the development of the
plan, and their experience in related studies.
o Planning Activities - Specify how the planning period will be used. The
application should include the specific aims and rationale for the planning
period, and descriptions of the activities to be carried out.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues. Because the participating ICs may have specific programmatic
interests in their use of the Planning Grant, you are encouraged to contact
relevant staff prior to submitting an application. A listing of NIH contacts
for the Clinical Trial Planning Grant (R34) program may be found at:
http://grants.nih.gov/grants/funding/r34.htm.
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
The title , NIH Clinical Trial Planning Grant (R34) Program, and number of
the program announcement (PA-04-008) must be typed on line 2 of the face page
of the application form and the YES box must be marked
APPLICATION RECEIPT DATES: Applications submitted in response to this
program announcement will be accepted at the standard application deadlines,
which are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular grant format. The modular grant format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the
research grant application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
For the NIH Clinical Trial Planning Grant (R34), you may request direct costs
in $25,000 modules, up to a total direct cost request of $100,000 for one
year.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and five signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will
not accept any application in response to this PA that is essentially the
same as one currently pending initial review unless the applicant withdraws
the pending application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous
critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within eight weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit. In general, continuity will be maintained between the
review of the planning grant application and the review of the eventual
application for the proposed clinical trial.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council
or board.
REVIEW CRITERIA
The NIH R34 is designed to support planning activities in preparation for a
full-scale Phase III clinical trial. These activities are primarily
logistical, conceptual, and/or technical in nature. They do not involve the
collection of data typical of research-related activities supported by the
traditional NIH research project grant. As such, the evaluation of R34
applications will focus on the justification of or need for the proposed
trial along with the appropriateness of the proposed planning activities.
The Future Clinical Trial:
(1) RATIONALE/SIGNIFICANCE
Are the significance and need to perform a future full-scale randomized
clinical trial (RCT) adequately justified? Would the results of the proposed
trial be likely to affect health care policy or practice?
(2) APPROACH
Are the conceptual framework, design, methods, and analyses, as currently
developed, appropriate for the aim of the future RCT?
The reviewers should consider the appropriateness of the intervention(s),
selection of endpoints, study population (inclusion/exclusion criteria),
randomization schemes, data management, statistical analysis, recruitment and
retention plans, and capacity to generalize results.
(3) INVESTIGATORS
Is the investigator appropriately trained and suited to carry out the
proposed trial? Is the work proposed appropriate to the experience level of
the Principal Investigator and the research team? Is there clear evidence of
leadership? Is there evidence documenting the investigators ability to
organize and manage complex projects?
(4) ENVIRONMENT
Does the scientific environment in which the proposed clinical will be
carried out contribute to the probability of success? Will the proposed
clinical trial take advantage of the unique features of the scientific
environment or employ useful collaborative arrangements? Is there evidence
of institutional support?
The Planning Period Activities:
(1) RATIONALE/SIGNIFICANCE
Is the planning period necessary? Will the activities planned enhance the
development of the future clinical trial? Will the proposed planning period
address major barriers to the future clinical trial?
(2) APPROACH
Evaluate the adequacy of the activities proposed for the planning period.
Will these activities contribute to the likelihood of timely and successful
trial implementation? Can these activities be accomplished in the proposed
time period? These activities may include, but are not limited to: (a)
developing/finalizing the MOP; (b) finalizing plans for addressing
gender/minority inclusion and human subjects protection requirements; (c)
establishing collaborative arrangements; (d) developing tools needed for data
collection and data management; (e) developing/finalizing safety and
monitoring plans (applicants are asked not to name individuals for the DSMB
but only to include areas of expertise that will be tapped in forming the
DSMB); (f) developing plans for Certification Training.
(3) INVESTIGATORS
Is the investigator appropriately trained and suited to carry out the
proposed planning activities? Is the work proposed appropriate to the
experience level of the Principal Investigator and the research team? Is
there clear evidence of leadership? Is there evidence documenting the
investigators ability to plan, organize, and manage complex projects?
(4) ENVIRONMENT/ORGANIZATION
Does the scientific environment in which the planning activities will take
place contribute to the probability of success? Are there adequate plans for
the development of an effective organizational structure for carrying out the
proposed trial? Are there adequate plans for the development of an essential
committee structure, e.g., Steering, Executive, Planning, Data and Safety
Committees? Does the application appropriately address issues such as the
flow of information to and from the Coordinating Center, to the enrolling
centers, and to the appropriate committees?
ADDITIONAL CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed activities.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
PA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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