NIDCD CLINICAL TRIAL PLANNING GRANT

Release Date:  October 20, 1999

PA NUMBER:   PAR-00-007

National Institute on Deafness and Other Communication Disorders

THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

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 clinical 
trials in its mission areas of hearing, balance, smell, taste, voice, speech 
and language. Investigators who submit applications for large-scale clinical 
trials for consideration by the NIDCD (see the NIDCD Investigator-Initiated 
Clinical Trials Program Announcement) are expected to provide detailed 
information regarding the study rationale, design, protocols and procedures, 
analytical techniques, facilities and environment, administrative procedures, 
and collaborative arrangements. Much of this information is best presented in 
a complete Manual of Procedures/Operations (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 clinical trials. 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.

HEALTHY PEOPLE 2000 

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2000," a PHS-
led national activity for setting priority areas.  This PA, NIDCD CLINICAL 
TRIAL PLANNING GRANT, addresses aspects of the priority area of diabetes and 
chronic disabling diseases. Potential applicants may obtain a copy of 
"Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary 
Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, 
Government Printing Office, Washington, DC 20402-9325 (telephone 202- 512-
1800), or at http://odphp.osophs.dhhs.gov/pubs/hp2000.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal government. Foreign organizations are not eligible to apply. 
Domestic applications may include international components; however, the 
domestic components must constitute the majority of the application. 
Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as principal investigators. 

MECHANISM OF SUPPORT

The mechanism of support will be the NIDCD Clinical Trial Planning Grant 
(R21), which will provide up to $75,000 in direct costs for one year. The 
award cannot be renewed. Specific application instructions have been modified 
to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining procedures of the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES 

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 
diseases 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 
clinical trial, particularly those involving 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 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).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 20, 
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 
23, No. 11, March 28, 1994, available on the web at the following 
URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

INCLUSION OF CHILDREN IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subject 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 children as subjects should 
read the "NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS 
PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS," which were published in 
the NIH Guide for Grants and Contracts, Volume 27, No. 8, March 6, 1998, and 
are available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

APPLICATION PROCEDURES 

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated 
in the application kit. Application kits are available at most institutional 
offices of sponsored research and may be obtained from the Division of 
Extramural Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-
0714, email GrantsInfo@nih.gov  and at the following URL address 
http://grants.nih.gov/grants/forms.htm.  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. 

The completed original application and three legible copies must be sent or 
delivered to: 

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710
BETHESDA, MD 20892
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
Executive Plaza South, 400C, MSC-7180
6120 Executive Boulevard
Bethesda, MD 20892-7180 
Rockville, MD 20852 (for express/courier service)

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach. The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers, and Institute 
staff. The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below.

SPECIFIC INSTRUCTIONS:

On the face page, item 2, mark "YES" and enter the title and number of this 
Program Announcement (NIDCD Clinical Trial Planning Grant). 

The body of the application must contain the following four elements: the 
rationale for the clinical trial; a full description of the experimental 
design of the clinical trial; plans for patient recruitment and retention; 
and, a description of the leadership and proposed organization of the 
clinical trial. For details of these four elements, see the REVIEW 
CONSIDERATIONS section.

BUDGET INSTRUCTIONS 

Modular Grant applications will request direct costs in $25,000 modules; 
applications responding to this PA cannot exceed a total direct cost request 
of $75,000. The total direct costs must be requested in accordance with the 
program guidelines and the modifications made to the standard 
PHS 398 application instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should  be completed, indicating Direct Costs 
(in $25,000 increments up to a maximum of $75,000) and Total Costs [Modular 
Total Direct plus Facilities and Administrative (F&A) costs] for the one-year 
budget period. Items 8a and 8b should also be completed indicating the same 
Direct and Total Costs.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD  Do not complete Form Page 4 
of the PHS 398. It is not required and will not be accepted with the 
application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT   Do not complete this 
categorical budget table on Form Page 5 of the PHS 398. It is not required 
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION  Prepare a Modular Grant Budget Narrative 
page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.) At the top of the page, enter the total direct costs requested 
for the year. This is not a Form page. 
o Under Personnel, List key project personnel, including their names, percent 
of effort, and roles on the project. No individual salary information should 
be provided. However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request. 

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for the year, rounded to the nearest 
$1,000. List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of key 
personnel, and the role on the project. Indicate whether the collaborating 
institution is foreign or domestic. The total cost for a consortium/ 
contractual arrangement is included in the overall requested modular direct 
cost amount. Include the Letter of Intent to establish a consortium.

o BIOGRAPHICAL SKETCH  The Biographical Sketch provides information used by 
reviewers in the assessment of each individual’s qualifications for a 
specific role in the proposed project as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below. No more than three pages 
may be used for each person. A sample biographical sketch may be viewed at: 
http://grants.nih.gov/grants/funding/modular/modular.htm.

- Complete the educational block at the top of the page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o CHECKLIST this page should be completed and submitted with the application. 
If the F&A rate agreement has been established, indicate the type of 
agreement and the date. All appropriate exclusions must be applied in the 
calculation of the F&A costs for the one-year budget period.

o The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review. 

REVIEW CONSIDERATIONS 

Applications will be assigned on the basis of established PHS referral 
guidelines.  An appropriate clinical trials peer review committee, convened 
by the NIDCD in accordance with the standard NIH peer review procedures, will 
evaluate applications that are complete for scientific and technical merit. 
As part of the initial review, all applications will receive a written 
critique and undergo a process in which only those applications deemed to 
have the highest scientific merit, generally the top half of applications 
under review, will be discussed, assigned a priority score, and receive a 
second level review by the National Deafness and Other Communication 
Disorders Advisory Council.  In the written review, comments on the following 
aspects of the application will be made in order to judge the likelihood that 
the proposed research will have a substantial impact on the pursuit of these 
goals.  Each of the following criteria will be addressed and considered in 
the assignment of the overall scientific merit rating. 


(1) Rationale.  The background and significance of the application must 
address the rationale for the future clinical trial (CT) including:
o a clear statement of the question that a 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 CT;
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 
study. 
 
(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 criteria; 
o strengths and weaknesses of the proposed methods and possible alternatives;
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. 

While the criteria listed above apply to all clinical trials, there are 
specific issues of particular relevance to multi-center 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 
inclusion; 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 multi-center trials, a 
core of potential center investigators and staffing for a coordinating 
center;
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 multi-center trials, the organizational structure of the trial, 
especially the organizational relationships among the enrollment centers and 
between the coordinating center and the enrollment centers.
		
AWARD CRITERIA 

Applications will compete for available funds with all other recommended 
applications.  Quality of the proposed project as determined by peer review, 
availability of funds, and program priority will be considered in making 
funding decisions.

INQUIRIES

Inquiries are strongly encouraged early in the development of the 
application.  The opportunity to clarify any issues or questions from 
potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. A. Julianna Gulya
Chief, Clinical Trials Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, 400D-7, MSC-7180
6120 Executive Boulevard
Bethesda, MD 20892-7180
Rockville, MD 20852 (for courier/express service)
Telephone: 301-435-4085
Fax: 301-402-6251
E-mail: julie_gulya@nih.gov

Direct inquiries regarding fiscal matters to: 

Ms. Sharon Hunt
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, 400-C, MSC-7180
6120 Executive Boulevard
Bethesda, MD 20892-7180
Rockville, MD 20852 (for courier/express service)
Telephone: 301-402-0909
Fax: 301-402-1758
E-mail: sh79f@nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.173.  Awards are made under authorization of the Public Health Service 
Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 
USC 241 and 285) and administered under NIH grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is 
not subject to the intergovernmental review requirements of Executive Order 
12372 or Health Systems Agency review. 

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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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