NIDCD Clinical Trial Planning Grant

RELEASE DATE:  August 27, 2002
PA NUMBER:  PAR-02-158

EXPIRATION DATE:  October 1, 2005

National Institute on Deafness and Other Communication Disorders (NIDCD)


o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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 National Institute on Deafness and Other 
Communication Disorders (NIDCD) is committed to fostering the development, 
and funding, of meritorious applications seeking to improve health by 
supporting well-executed phase III clinical trials (see definition in PHS 398 
rev. 5/2001) in its mission areas of hearing, balance, smell, taste, voice, 
speech and language. Investigators who submit applications for phase III 
clinical trials for consideration by the NIDCD (see the NIDCD Investigator-
Initiated Phase III Clinical Trials Program Announcement at 
( are 
expected to provide detailed information regarding the study rationale, 
design, protocols and procedures, and collaborative arrangements. Much of 
this information is best presented in a complete Manual of Operations and 
Procedures (MOP) submitted as part of the application. It is recognized that 
the development of a MOP is a time-consuming and expensive activity. The 
NIDCD Clinical Trial Planning Grant is intended to help support this and 
other related activities necessary to develop a clinical trial. The Planning 
Grant also allows for peer review of the rationale for, and design of, 
clinical trials of interventions aimed at preventing or treating diseases and 
disorders of hearing, balance, smell, taste, voice, speech and language. 

Applicants should be aware that the award of a Clinical Trial Planning Grant 
does not guarantee NIDCD acceptance of the full-scale phase III clinical 
trial for peer review, nor subsequent funding of the trial following peer 
review. It is expected that the applicant will develop a full-scale phase III 
clinical trial application if the Clinical Trial Planning Grant is funded.

This PA supersedes PAR–00-007 (October 20, 1999).


The objective of the NIDCD Clinical Trial Planning Grant is to address 
preliminary design and methodological issues for specific clinical trials 
intended to evaluate interventions for the treatment or prevention of disease 
and disorders of hearing, balance, smell, taste, voice speech and language. 
The NIDCD Clinical Trial Planning Grant supports the development of specific 
elements essential to the conduct of a successful phase III clinical trial, 
particularly one that involves multiple centers. Examples of these elements 
include adequate plans for recruitment of patients, experimental design and 
protocols, data management, analytical techniques, facilities, administrative 
procedures and collaborative arrangements. Detailed information regarding the 
rationale for 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).


This PA will use the NIH R21 award mechanism, which will provide up to 
$100,000 in direct costs for one year. The award cannot be renewed. 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   


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 (domestic applications may include a foreign component; however, 
the domestic component must constitute the majority of the application). 

Foreign institutions are not eligible to apply.


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.  


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 

o Direct your questions about scientific/research issues to:

Staff Contact: A. Julianna Gulya, MD
Division: Division of Extramural Research
Institute: NIDCD
Building: EPS Room 400D
Bethesda, MD  20892-7180
Telephone:  (301) 435-4085
FAX:  (301) 402-6251

o Direct your questions about peer review issues to: 

Name: Craig Jordan, PhD
Division: Division of Extramural Research
Institute: NIDCD
Building EPS, Room 400C
Bethesda, MD  20892-7180
Telephone:  (301)496-8683 
FAX: (301) 402-6250

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

Name: Sara Stone
Division: Division of Extramural Research
Institute: NIDCD
Building EPS, Room 400B
Bethesda, MD  20892-7180
Telephone:  (301) 402-0909
FAX: (301) 402-1758 

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at  Application 
deadlines are also indicated in the PHS 398 application kit.

As with most applications to NIH, the research plan is limited to 25 pages. 
All information for review of the NIDCD Clinical Trial Planning Grant 
application must be included in the body of the application; appendices will 
not be considered during the review for this mechanism. 

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 
includes step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and three 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)

In order to facilitate the review of applications assigned to the NIDCD, the 
applicant should, at the same time, mail or deliver TWO copies of the 
application to: 

Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
EPS, 400C
Bethesda, MD 20892-7180
Rockville, MD 20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 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 


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 
( 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

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 

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 

(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 

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. In keeping with NIH policy (see "MONITORING PLAN 
AND DATA SAFETY AND [sic] MONITORING BOARD" below) all clinical trials 
require data and safety monitoring.

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.


(1) Rationale. The background and significance of the application must 
address the rationale for the future phase III clinical trial (CT) 
o a clear statement of the question that the CT would address;
o information adequate to determine the significance and timeliness of, as 
well as the need to perform, the CT;
o the biological mechanisms and clinical data that support conducting a 
o impact on health care;
o reasons for selection of intervention and mode of delivery, including 
specific details such as dose or a particular procedure;
o competitive therapies including both clinical and economic advantages 
and disadvantages of each; and,
o the ethical issues surrounding the CT and the disease/condition under 

(2) Study Design. The application for a planning grant must include a full 
description of the experimental design of the CT, including such 
elements as the following:
o translation of the clinical question into a statistical hypothesis;
o endpoint(s) and data to be collected including relevance to the clinical 
and statistical hypothesis being tested;
o sample size and duration of the CT;
o randomization, masking (if appropriate), and inclusion/exclusion 
o strengths and weaknesses of the proposed methods and possible 
o ancillary therapies;
o plans to standardize and monitor adherence to the clinical protocol in 
each center; and,
o methods for standardization of procedures for data management and 
quality control.

Whereas the criteria listed above apply to all clinical trials, there are 
specific issues of particular relevance to multicenter trials, which must 
also be addressed, such as standardization/quality control of, and 
adherence to, the clinical protocol and data collection or distribution 
guidelines, and the use of a data coordinating center.

(3) Plans for Patient Recruitment/Retention. The application must include 
an assessment of the following items:
o availability of the requisite eligible patient pool;
o availability of children, women and minority individuals as trial 
participants and specific recruitment and retention plans for their 
o the status of evidence showing whether or not clinically important 
sex/gender and race/ethnicity differences in the intervention effect are 
below) ; and,
o plans for recruitment outreach and, as appropriate, follow-up procedures 
to ensure collection of data at stated intervals.

(4) Investigators. The application must include a clear statement of the 
leadership and proposed organization of the CT, including:
o identification of a principal investigator, and, for multicenter trials, 
a core of potential center investigators and staffing for a coordinating 
o professional training and experience of the CT organizers in such areas 
as the clinical problem under study, administration of complex projects 
and study design;
o inclusion of statisticians, data managers and study coordinators;
o plans to add or drop centers;
o essential committee structure appropriate to the complexity of the trial 
(e.g., Planning, Steering, Executive Committees); and,
o for multicenter trials, the organizational structure of the trial, 
especially the organizational relationships among the enrollment centers 
and between the coordinating center and the enrollment centers.


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


involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 

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 
(; a complete 
copy of the updated Guidelines are available at
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 

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 

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see   
It is the responsibility of the applicant to provide the official NIH 
identifier(s) for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 

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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.173, 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 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.

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