CLINICAL TRIAL PLANNING GRANT

RELEASE DATE:  July 1, 2002

PA NUMBER:  PAR-02-119

EXPIRATION DATE:  October 24, 2003, unless reissued. 

National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIAMS, 
 (http://www.niams.nih.gov/)

Application Receipt Dates: October 24, 2002, June 24, 2003, and October 24, 
2003.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) 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 NIAMS Clinical Trial Planning Grant is to provide support 
for the organization of activities critical for the successful implementation 
of clinical trials in areas within the NIAMS mission.  The planning grant is 
intended to (a) allow for early peer review of the rationale and design for 
high risk, complex, or large-scale clinical trials, (b) provide support for 
the development of a detailed clinical trial research plan, including a 
manual of operations and procedures, as a means of decreasing the long start-
up time often needed for initiating large trials after award, and (c) provide 
support to refine critical components of a clinical trial, such as 
experimental design, analytical techniques, recruitment strategies, data 
management, and collaborative arrangements.  The purpose of the NIAMS 
planning grant is not to obtain preliminary data, nor to conduct studies to 
support the rationale for the clinical trial.

Applicants should be aware that the award of a planning grant does not 
guarantee NIAMS acceptance of the full-scale clinical trial for peer review, 
or subsequent funding of the trial following peer review.  However, it is 
expected that the applicant will develop a full-scale clinical trial for 
submission to a public or private agency if the Clinical Trial Planning Grant 
is recommended for funding.

RESEARCH OBJECTIVES

Complex, high risk, or large-scale clinical trials require extensive 
planning.  The NIAMS Clinical Trial Planning Grant supports the development 
of specific elements essential to the conduct of a successful clinical trial.  
Examples of these elements include adequate plans for recruitment and 
retention of patients, experimental design and protocols, data management, 
analytical techniques, identification of facilities, administrative 
procedures, and collaborative arrangements.  Detailed information regarding 
the rationale of the clinical trial, based on adequate, preclinical science 
and preliminary clinical research, must be developed prior to submission and 
included in the application for a Clinical Trial Planning Grant.  The purpose 
of the planning grant is not to obtain preliminary data or to conduct studies 
to support the rationale for the clinical trial. The expected product of the 
Clinical Trial Planning Grant is a detailed clinical trial research plan 
including a complete manual of operations and procedures (MOP).  The NIAMS 
Clinical Trial Planning Grant is intended to help support this and other 
related activities necessary for a successful clinical trial.

For some diseases of interest to the NIAMS the design and implementation of 
successful clinical trials has been hampered by the lack of refined outcome 
measures, difficulties with recruitment of patients with rare diseases, and 
lack of information about standardization of procedures among participating 
clinics.  The NIAMS Clinical Trial Planning Grant also provides an 
opportunity to support these activities.

The actual activities performed during the planning period will depend upon 
the nature of the trial, and the degree to which the investigators have 
already developed their trial.  The planning activities should be such that 
they would enable imminent commencement of the actual clinical trial.  A few 
examples are:

o Evaluating recruitment strategies

o Developing subject retention strategies

o Conducting meetings to address issues such as trial design, methodologies, 
etc.

o Preparing a Manual of Operations and Procedures (MOP), a specific safety 
plan, etc.

Detailed information regarding the rationale of the clinical trial, based on 
adequate preclinical science and preliminary clinical research, must be 
developed prior to submission and included in the Clinical Trial Planning 
Grant application.  The purpose of the planning grant is not to support 
activities of a pilot trial or to conduct studies to support the rationale 
for the clinical trial.  Examples of expected products of the planning grant 
are a complete Manual of Operations and Procedures, validated outcome 
measures, or proven feasibility of a new recruitment plan.

Any disease area that is within the NIAMS mission is appropriate for 
consideration under this PA.

MECHANISM(S) OF SUPPORT 

This PA will use the NIH R21 award mechanism.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project. 

This PA uses just-in-time concepts. It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). This 
is a one-year award, for up to a total direct cost request of $100,000.

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
o Faith-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. 

Also, new investigators are encouraged to apply. They may wish to develop 
small, focused research projects that provide initial findings for larger 
research proposals in the future. It would be expected that such applications 
also would have smaller budgets reflecting the scope of the research 
proposed.  

SPECIAL REQUIREMENTS

The Research Plan should be presented in two parts as described below, and 
must be limited to 15 pages.  Appendix material, with the exception of color 
glossy photographs, will not be accepted. Applicants are encouraged to 
address issues listed in "Review Criteria" and "Other Review Criteria" in 
this PA.

PART 1 - FUTURE CLINICAL TRIAL  (Approximately 2-5 pages)

This part may or may not be written using the standard headings of PHS form 
398 (Specific Aims, Background and Significance, Preliminary Studies, 
Research Design and Methods, and Human Subjects) but should clearly describe 
the following items: 

o Specific Aims, including a clear statement of any hypotheses that the 
clinical trial would address.

o Background/Rationale - Provide rationale for the trial.  The rationale must 
be supported by existing data/information.  The planning grant is not to be 
used to conduct studies in order to rationalize the clinical trial.

o Significance - Give information documenting significance and the need to 
perform the clinical trial.  Describe the potential impact of the clinical 
trial on health care: What is the need for new therapy?  What are the 
potential advantages and disadvantages of competitive therapies? 

o Research Design and Methods - No details are required, but enough 
information should be provided to evaluate how the trial would be conducted.  
Pertinent information must be included on: (a) Intervention(s) to be used, 
reasons for the selection of intervention(s), and mode(s) of delivery, (b) 
study design, treatment group(s), trial size, and inclusion/exclusion 
criteria (if not developed yet, please state so, and you may include it as a 
part of your planning grant part 2), (c) control group(s) if applicable, (d) 
outcome measures, and (e) data analysis plan if applicable.

o Proposed Clinical Sites and Investigators-provide a list.  Letters of 
commitment are not required at this stage.

Discussion of the below two topics are not subject to page limits.

o Gender, Minorities and Children Issues - Proposed population description in 
terms of gender, minorities and children, justification for excluding any 
gender, minority groups or children, plans for recruitment outreach, as 
appropriate.

o Human Subjects Issues - Ethical considerations for placebo/control groups, 
risk/benefit for the participants, availability of the requisite eligible 
patient pool.

PART 2 - PLANNING GRANT (Approximately 10-13 pages)

This part must be written using the PHS form 398 headings, and should 
include:

a.  Specific Aims for the planning period (examples include: "We will prepare 
a Manual of Operations and Procedures", "We will conduct meetings to address 
the following issues:", "We will test recruitment strategies", "We will 
organize essential safety committees", etc.).

b.  Background and Significance, including rationale for planning period, why 
is the planning period needed?  Why not start the trial now?

c.  Preliminary Studies - Not required, but if any preliminary work already 
completed is included, it should be relevant to the work proposed in the 
planning period, and to the trial proposed in Part 1.

d.  Research Design and Methods - Detailed approach for each Specific Aim of 
the planning period.  Highlight any innovations applicable to the planning 
period.

Discussion of the below topic is not subject to page limits.

e.  Human Subjects - Address all the required items on human subjects for 
anticipated issues arising in the planning phase.  If no human subjects 
issues are involved during the planning period, state so.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants. 

o Direct your questions about scientific/research issues to:

Dr. Deborah Ader
Behavioral & Prevention Research
NIH, NIAMS, EP
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD  20892-4872
Telephone: (301) 594-5032 
FAX: (301) 480-4543 
Email:  [email protected]

Dr. Gayle Lester
Osteoarthritis Initiative & Diagnostic Imaging
NIH, NIAMS, EP
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD  20892-4872
Telephone: (301) 594-5055 
FAX: (301) 480-4543 
Email:  [email protected]

Dr. Joan McGowan
Bone Diseases
NIH, NIAMS, EP
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD  20892-4872
Telephone: (301) 594-5055
FAX: (301) 480-4543
Email: [email protected] 

Dr. Alan N. Moshell
Skin Diseases
NIH, NIAMS, EP
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD  20892-4872
Telephone: (301) 594-5017
FAX: (301) 480-4543
Email: [email protected] 

Dr. James S. Panagis
Orthopaedics
NIH, NIAMS, EP
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD  20892-4872
Telephone: (301) 594-5055
FAX: (301) 594-4543
Email: [email protected] 

Dr. Susana A. Serrate-Sztein
Rheumatic Diseases
NIH, NIAMS, EP
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD  20892-4872
Telephone: (301) 594-5032
FAX: (301) 480-4543
Email: [email protected] 

o Direct your questions about peer review issues to:

John Lymangrover, Ph.D.
Scientific Review Branch
NIH, NIAMS, EP
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD  20892-4872
Telephone:  (301) 594-4952
FAX:  (301) 480-4543
Email:  [email protected]

o Direct your questions about financial or grants management matters to: 

Melinda Nelson
Grants Management Office
NIH, NIAMS, EP
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, MD  20892-4872
Telephone: (301) 594-3535
FAX: (301) 480-5450
Email: [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  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: [email protected].

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Because the CTPG 
applications are limited to $100,000 per year in direct costs, they 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.

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 received by or 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.

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 by NIAMS in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
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 second level review by the appropriate national advisory council 
or board

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

OTHER REVIEW CRITERIA:  

The criteria used to evaluate Clinical Trial Planning Grant applications are 
based on the "Specific Requirements," as spelled out in an earlier section of 
this PA.  The reviewers will provide a two-part critique on the application.

Please note that there may be high enthusiasm for the future trial (part 1) 
but little enthusiasm for the planning (part 2), or vice versa, or high 
enthusiasm for both, etc.  Review committees should indicate their enthusiasm 
for the two sections separately (with only one priority score for the overall 
application).

o PART 1 - This will be a brief critique of the future clinical trial, and 
will be based upon the items requested under part 1 of "Special Requirements" 
of this PA.  General enthusiasm (low, medium, high) about the proposed trial 
should be based on the following:

(1) Significance:  Would the future clinical trial address an important 
problem?  Would conduct of the trial influence standard of care, develop a 
new therapy, or provide a better understanding of the disease?  Is there 
convincing rationale to conduct the trial?

(2) Investigator:  Is the investigative team qualified to conduct the 
clinical trial?

(3) Feasibility: Do the research design and methods appear appropriate and 
reasonable for the successful conduct of the proposed trial?  (Please note 
that detailed research design and methods are NOT required.)

(4) Human Subjects:  Any concerns involving the participation of human 
subjects will be noted.

o PART 2 - This will be a detailed critique of the planning period 
activities, and will be based upon the items requested under part 2 of 
"Special Requirements" of this PA.

(1) Significance:  Will the proposed planning process address major barriers 
in conducting the future clinical trial?  Is the planning period necessary?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies? 

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator and other researchers (if any)?

(5) Environment:  Does the environment in which the work will be done 
contribute to the probability of success?  Do the proposed Aims take 
advantage of unique features of the environment or employ useful 
collaborative arrangements?  Is there evidence of institutional support? 

(6) Gender, Minorities, and Children: (Applicable only if human subject 
issues are involved in the planning period.)  The adequacy of plans to 
include both genders, minorities, and children as appropriate for the 
scientific goals of the research will be evaluated.  

(7) Human Subjects: (Applicable only if human subject issues are involved in 
the planning period) Ethical issues surrounding human subjects will also be 
evaluated.

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 

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete
copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

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 No. 93.846, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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.
http://grants.nih.gov/grants/guide/pa-files/PA-02-015.html. 

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