Full Text DK-97-011
 
INTERSTITIAL CYSTITIS CLINICAL TRIALS GROUP
 
NIH GUIDE, Volume 26, Number 15, May 9, 1997
 
RFA:  DK-97-011
 
P.T. 34

Keywords: 
  Digestive Diseases & Disorders 
  Clinical Trial 

 
National Institute of Diabetes and Digestive and Kidney Diseases
 
Letter of Intent Receipt Date:  July 25, 1997
Application Receipt Date:  August  26, 1997
 
PURPOSE
 
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) announces the availability of a Request for Applications
(RFA) to establish an Interstitial Cystitis Clinical Trials Group.
The purpose of this RFA is to solicit applications from institutions
interested in participating in a cooperative group to plan, direct,
and conduct clinical trials in patients with interstitial cystitis
(IC).  This RFA will establish and maintain clinical centers required
to perform multiple therapeutic trials, either sequentially or
concurrently, for treatments of IC using common protocols with
appropriate sample sizes.  This RFA will also establish a Data
Coordinating Center for the clinical trials group to coordinate the
development of protocols for the trials and to support the
collection, quality control, and analysis of the data.
 
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 RFA,
Interstitial Cystitis Clinical Trials Group, relates to the priority
areas of chronic disabling conditions and prevention services.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report: Stock No. 017-001-00473-1) through Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone number 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic institutions; public and
private organizations (for-profit and non-profit), such as
universities, colleges, hospitals, units of State and local
government; and eligible agencies of the Federal government.  Foreign
institutions are not eligible to apply.  Racial/ethnic minorities,
women, and persons with disabilities are encouraged to apply as
principal investigators.
 
MECHANISM OF SUPPORT
 
The administrative and funding instrument to be used for these awards
will be the cooperative agreement (U01). The cooperative agreement is
an assistance mechanism in which substantial NIDDK scientific and
programmatic involvement is anticipated during performance of the
activity.  Under the cooperative agreement, the NIDDK's purpose is to
support and encourage the recipient's activities by working jointly
with the awardees in a partnership role, but not to assume direction,
prime responsibility, or dominance.  Details of the responsibilities,
relationships, and governance of a study funded under a cooperative
agreement are described under the section entitled "Terms and
Conditions of Award."
 
The total project period for applications submitted in response to
the present RFA may not exceed five (5) years.  The anticipated award
date is March 1, 1998. Because the nature and scope of the research
proposed in response to this RFA may vary, it is anticipated that the
sizes of awards will also vary.
 
At this time, the NIDDK has not determined whether or how this
solicitation will be continued beyond the present RFA.
 
FUNDS AVAILABLE
 
The NIDDK plans to make five awards for clinical centers and one
award for a Data Coordinating Center. Approximately $2,000,000 total
cost (total cost = direct plus indirect costs) is expected to be
available for the first year of support under this RFA.  It is
anticipated that the award for each clinical center will be about
$275,000 total cost for the first year and the award for the Data
Coordinating Center will be about $625,000 total cost for the first
year.
 
The number of awards to be made is dependent on the receipt of a
sufficient number of applications of high scientific merit and
availability of funds.  Although this program is provided for in the
financial plans of the NIDDK, awards pursuant to this RFA are
contingent upon the availability of funds for this purpose.
 
RESEARCH OBJECTIVES
 
A.  Background
 
Interstitial cystitis is often times a disabling disease
characterized by bladder pain, urgency, frequency, nocturia, and
dysuria.  The disease primarily affects women, the female to male
ratio being 9:1 in several studies.  Realizing that IC was often
misdiagnosed, workshops on IC held in 1987 and 1988 by the NIDDK
resulted in the development of inclusion and exclusion criteria for
patients being considered for research studies of the disease.
Despite the development of these criteria, meaningful epidemiological
studies on IC have not been conducted in the United States during the
past decade.  Thus, our knowledge about the epidemiology, natural
history, and risk factors for IC is rudimentary. Moreover, the
cause(s) of IC is not known.  Because of this lack of information,
the NIDDK initiated a prospective, clinical, longitudinal study on IC
called "The Interstitial Cystitis Database (ICDB) Study."  Begun in
1991, the ICDB Study, a cooperative agreement supported program, has
enrolled over 600 women and men into this project that is scheduled
to complete the follow-up of participants in the fall of 1997.  A
wealth of clinical, demographic, and pathological (bladder biopsies)
information has been collected by ICDB Study
investigators which has provided valuable insights into this disease.
Based on the findings from the ICDB Study, investigators are now in a
position to better characterize the spectrum of disease severity
observed in IC patients and to consider outcome measures that are
meaningful to these patients.  In addition, the distribution of
medical and non-traditional treatments utilized by ICDB Study
participants has also been well documented.
Because the etiology and pathophysiology of IC are not known,
physicians are limited to treating the symptoms of IC patients.
Although a number of medical therapies are available for treatments,
neither their long-term effectiveness nor their specificity for the
individual characteristics of the disease is well known.  Many
previous clinical trials for IC therapy have suffered from a number
of design flaws including small sample size, lack of masking of
treatment, short-term follow-up, ambiguous definitions of IC, absence
of characterizing disease severity, and questionable endpoints.  In
addition, little is known about the effectiveness of medical
treatments used in combination. The lack of conclusive outcomes from
well-organized and conducted randomized clinical trials has resulted
in many physicians using a trial-and-error approach to therapy and
this management has led many IC patients to seek non-traditional
approaches to control their disease. Based on the findings from the
ICDB Study, the NIDDK has determined that a series of randomized,
controlled multicenter clinical trials studying well-characterized
patients and measuring meaningful subjective and objective endpoints,
are now feasible to evaluate the effectiveness of currently available
and newly developed medical therapies for patients with IC.
 
B.  Research Goals and Scope
 
The purpose of this RFA is to initiate a collaborative study of
treatment interventions for IC.  This program will provide a
mechanism to establish and maintain Clinical Centers which will
perform multiple therapeutic trials in patients with IC.  The
therapeutic trials may involve investigational drugs, approved agents
not currently used, drugs currently used in treatment of IC, or
non-drug approaches.
 
It is expected that these trials will take place in five Clinical
Centers over a period of five years.  The Clinical Centers will
randomize approximately 1,000 participants for the various clinical
trials conducted during the lifetime of this program.
 
The data collection activities of the Clinical Centers will be
supported by a single Data Coordinating Center.
 
C.  Study Design
 
It is envisioned that over the five-year period, several multicenter
clinical trials will be developed and implemented by the Principal
Investigators.  The individual Clinical Centers within the IC
Clinical Trials Group should emphasize clinical trials that can be
conducted under mutually agreed upon protocols.  The study population
is envisioned to be IC patients encompassing a broad range of age
groups and consisting of appropriate gender and minority
representation. Patients with a broad range of disease severity
should also be included.
 
Applicants for both Clinical Centers and the Data Coordinating Center
should propose two examples (conducted either concurrently or
sequentially) of clinical protocols requiring multicenter
participation that they consider important. For each example
applicants should submit concept documents not more than four pages
long, that briefly outline the rationale and background of the
proposed clinical trials, study design, type of patients to be
included in the protocols, eligibility criteria, and baseline and
outcome measures.  For each of the clinical protocols, Clinical
Center applicants should discuss the characteristics and number of
potential participants that would be available from their own
geographic region.
 
The topics for the Clinical Trials Group will be proposed and
prioritized by the Steering and Planning Committee based on protocols
submitted and approved during review, but the actual number of
clinical trials conducted will be dependent upon availability of
funds.
 
STUDY COMPONENTS
 
1.  Clinical Centers
 
A Clinical Center is an institution that is actively involved in the
recruitment, evaluation, treatment, and follow-up of study
participants.  It should consist of an interdisciplinary team of
clinical investigators and appropriate personnel, such as a research
coordinator and clerical staff.  An application for a Clinical Center
should provide evidence that the investigators are capable of
recruiting a sufficient number of participants for the proposed
trials.  Applicants for Clinical Centers should describe the target
population from which they expect to randomize the required number of
study participants and plans for recruitment of women and minorities.
Clinical Centers will be required to submit protocol data
expeditiously.  Clinical Centers must work in concert with the Data
Coordinating Center to implement procedures for data audits and other
data quality control procedures as established by the study protocol.
The Principal Investigator and  Co-Investigators in each Clinical
Center should be skilled in collaborative clinical investigation.
There should be evidence of strong institutional support for the
Clinical Center, including adequate space in which to conduct clinic
activities and office space for staff.  An organizational structure
for the Clinical Center should be set forth in the application
delineating lines of authority and responsibility for dealing with
problems in all general areas as well as stated willingness to follow
the stated common protocols.
 
The applicant should include a succinct discussion of previous
relevant investigational efforts.  The applicant should also discuss
in detail the recruitment strategies to procure the expected number
of randomized participants, approaches to attain high levels of
adherence to the interventions, and high rates of follow-up.
Specific plans for recruitment of minority participants must also be
discussed.
 
2.  Data Coordinating Center
 
The Data Coordinating Center will have primary responsibility for
collecting, editing, storing, and analyzing data generated by the
Clinical Centers.  It should be prepared to assume a key role in
overseeing implementation and adherence to the study protocol, and
assuring quality control of the data collected.  The Data
Coordinating Center will be expected to provide appropriate
biostatistical, data management, and coordination expertise.  The
Data Coordinating Center also will be expected to provide
appropriately detailed reports to the Steering and Planning Committee
and to the External Advisory Committee at regular intervals and will
be responsible for the logistics and planning of the meeting of these
committees and their subcommittees. Applicants for the Data
Coordinating Center should provide a detailed description of prior
experience in multicenter studies.
 
3.  Steering and Planning Committee
 
The primary governing body of the study will be the Steering and
Planning Committee comprised of each of the Principal Investigators
of the Clinical Centers and the Data Coordinating Center, the
Chairperson of the Steering and Planning Committee, and the NIDDK
Project Scientist (described in detail under Terms and Conditions).
 
4.  External Advisory Committee
 
An independent committee supported by the NIDDK and composed of
experts in urology, biostatistics, clinical trials, and bioethics who
are not otherwise involved in the study will be established to review
periodically the progress of the study (described in detail under
Terms and Conditions).  This Committee will also be responsible for
reviewing the acceptability of initial data quality monitoring plans
established by the Steering and Planning Committee and the subsequent
monitoring of data quality by means of reports prepared by the Data
Coordinating Center.
 
5.  Project Scientist
 
The NIDDK will identify a Project Scientist for the study.  The
Project Scientist will assist the Steering and Planning Committee and
External Advisory Committee in carrying out the study (described in
detail under Terms and Conditions).
 
6.  Study Phases
 
The timetable for the study may be subdivided into three phases over
a five-year period.  There may be some overlap in functions within
each of the phases, and the time estimates are only approximations.
The purpose of the phases is to provide broad guidelines of the total
scope of work to be accomplished for this RFA.
 
Phase I: Planning and development of the clinical trial group
infrastructure, protocol development; months 1 to 12.
 
Phase II: Patient recruitment; protocol implementation, further
protocol development; months 13 to 60.
 
Phase III: Data Analysis; report preparation; protocol development
and recruitment for next studies; months 24-60.
 
The first twelve months of the study (Phase I) may be devoted to
planning and development of the clinical trials group infrastructure
and committee structure. Possible objectives for the Steering and
Planning Committee are to determine patient eligibility criteria for
initial clinical trials; train staff in procedures; help set up data
acquisition and consent forms; define terms and outcome measures;
develop a manual of operations, questionnaires, procedures for
quality control; determine priorities for protocol development; and
begin to develop specific protocols.
 
The Data Coordinating Center will also play a key role in the
planning and development stage.  Possible objectives for the planning
and development stage for the Data Coordinating Center, in addition
to assisting Clinical Centers in their planning and organization of
the clinical trials group, are to help develop study protocols,
randomization and analytic plans; select a data acquisition,
transfer, and management system; develop procedures for quality
control, training, and certification; develop and produce a Manual of
Operations; and take the lead for the orderly accumulation and
transmission of data for the clinical trials group.
 
In Phase II, the Clinical Centers will select and prioritize common
protocols, proceed with subject recruitment and protocol
implementation for the first studies ,and concurrently develop
additional protocols. Possible objectives for Phase II for the Data
 
Coordinating Center are to assist the Clinical Centers with respect
to completing protocol development, patient recruitment,
randomization, data acquisition, and ongoing quality control.
 
In Phase III, after the last patients in the first study have
completed their follow-up measurements, Clinical Centers will review
their data and assist the Data Coordinating Center in the close-out
of the initial study.  Initiation of patient accrual will begin for
the next studies, and protocol development will continue for
subsequent trials.  Depending upon the sample sizes and resources
available to the Clinical Centers and the Data Coordinating Center,
it may be possible to conduct two or more trials concurrently.  The
Data Coordinating Center will continue with its activities in data
management, editing, data analysis, and protocol development.  It
will also support manuscript preparation through data analysis,
statistical consultation, editorial tasks, and coordination of
meetings.
 
7.  Budget
 
Applications for the Clinical Centers and the Data Coordinating
Center must include a year-by-year budget that is adequately
justified.
 
For a Clinical Center, the budget should request support for the
minimum number of full-and/or part-time staff to successfully carry
out the proposed trials.  A Clinical Center could include a Principal
Investigator, Co-Investigator, Study Coordinator, and Data Entry
Clerk.  The budget should include support for travel for two key
investigators to attend bi-monthly Steering and Planning Committee
Meetings during Phase I and quarterly meetings during Phase II.
Steering and Planning Committee Meetings will be held in the
Washington, D.C. area. Travel for centralized training of the study
coordinator and data entry clerk must also be budgeted (assume
central training to be held in the Washington, D.C. annually during
years 1 through 5).
 
For applications for the Data Coordinating Center, the budget should
also include the time and effort of key personnel needed to conduct
the trials and the required number of and cost of computers to be
used at the Clinical Centers for distributed data entry.  Travel to
Washington, D.C. for External Advisory Committee Meetings (two per
year), Steering and Planning Committee Meetings (six in Year 1-Phase
I and three annually in Phases II and III -Budget Years 2-5), and
site visits (five visits for years 2-5) is to be included in the
budget.  The Data Coordinating Center should also budget for travel
for the Chairperson of the Steering and Planning Committee (six
meetings in Year 1 and three in Years 2-5).
 
SPECIAL REQUIREMENTS
 
Terms and Conditions of Award
 
The following terms and conditions will be incorporated into the
award statement and provided to each Principal Investigator as well
as to the institutional officials at the time of the award.  These
terms are in addition to, not in lieu of, otherwise applicable Office
of Management and Budget (OMB) administrative guidelines, HHS Grant
Administration Regulations at 45 CFR Part 74 and 92, and other HHS,
PHS, and NIH Grants Administration policy statements.
 
The administrative and funding instrument used for this program is
the cooperative agreement (U01), an "assistance" mechanism (rather
than an "acquisition" mechanism), in which substantial NIH scientific
and/or programmatic involvement with the awardee is anticipated
during the performance of the activity.  Under the cooperative
agreement, the NIH purpose is to support and/or stimulate the
recipient's activity by involvement in and otherwise working jointly
with the award recipient in a partner role, but it is not to assume
direction, prime responsibility, or a dominant role in the activity.
Consistent with the cooperative agreement concept, the dominant role
and prime responsibility for the planned activity resides with the
awardees for the project as a whole, although specific tasks and
activities in carrying out the activity will be shared among the
awardees and NIDDK Project Scientist.
 
A.  Awardee Rights and Responsibilities
 
Awardees will have substantial and lead responsibilities in all tasks
and activities.  These include protocol development, patient
recruitment and follow-up, data collection, quality control, final
data analysis and interpretation, and preparation of publications.
The awardee agrees to work cooperatively with the other Clinical and
Data Coordinating Centers and agrees to follow the common protocol
and Manual of Operations developed by the Steering Committee.  The
awardee also agrees to transmit all study data to a central Data
Coordinating Center for combination and analysis. Awardees will
retain custody of and have primary rights to their data developed
under these awards, subject to Government (e.g., NIDDK, NIH, or PHS)
rights or access consistent with current HHS, PHS, and NIH policies.
 
B.  NIDDK Staff Responsibilities
 
The NIDDK will name a Project Scientist from within the Division of
Kidney, Urologic and Hematologic Diseases whose function will be to
assist the Steering and Planning Committee and External Advisory
Committee in carrying out the study.  The Project Scientist will be a
voting member of all key study group subcommittees and will serve as
Executive Secretary of the External Advisory Committee.  The Project
Scientist will have substantial scientific-programmatic involvement
in quality control, interim data analysis, safety monitoring, and
final data analysis and interpretation, preparation of publications,
and coordination and performance monitoring.  The dominant role and
prime responsibility for these activities resides with the awardees
for the project as a whole, although specific tasks and activities in
carrying out the studies will be shared among the awardees and the
NIDDK Project Scientist.
 
The NIDDK Project Scientist will have voting membership
on the Steering and Planning Committee and, as determined by that
committee, its subcommittees.
 
The NIDDK reserves the right to terminate or curtail the study (or an
individual award) in the event of substantial shortfall in
participant recruitment, follow-up, data reporting, quality control,
or other major breach of the protocol, reaching a major study
endpoint substantially before schedule with persuasive statistical
significance or human subject ethical issues that may dictate a
premature termination.
 
C. Collaborative Responsibilities
 
A Steering and Planning Committee, composed of the Principal
Investigators of each Clinical Center, the Principal Investigator of
the Data Coordinating Center, and the NIDDK Project Scientist will be
the main governing board of the study and will have primary
responsibility for developing common study designs, protocols and
manuals; facilitating the conduct and monitoring of studies, and
reporting study results.  Each Principal Investigator from a Clinical
Center and the Data Coordinating Center as well as the NIDDK Project
Scientist, will have one vote.  The chairperson, who will be someone
other than an NIDDK staff member, will be selected by the Steering
and Planning Committee. Subcommittees will be established by the
Steering and Planning Committee, as it deems appropriate; the Project
Scientist will serve on subcommittees as he/she deems appropriate.
 
The collaborative protocols will be developed by the Steering and
Planning Committee.  Data will be submitted centrally to the Data
Coordinating Center.  Protocols will define access to data and
publications.  An independent External Advisory Committee, to be
appointed by the NIDDK, will review progress at least annually and
report to the NIDDK.
 
Awardees will be required to accept and implement the common
protocol(s) and procedures approved by the Steering and Planning
Committee.
 
D.  Arbitration
 
Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award) between recipients and the NIDDK may
be brought to arbitration.  An arbitration panel will be composed of
three members - one selected by the Steering and Planning Committee
(with the NIDDK member not voting) or by the individual awardee in
the event of an individual disagreement, a second member selected by
NIDDK, and the third member selected by the two prior selected
members. This special arbitration procedure in no way affects the
awardee's right to appeal an adverse action that is otherwise
appealable in accordance with the PHS regulations at 42 CFR Part 50,
Subpart D and HHS regulation at 45 CFR Part 16.
 
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
1003-43).
 
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 28, 1994 (FR 59 14508-14513), and in the
NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23,
Number 11.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by July 25, 1997, a
letter of intent that includes a descriptive title of the proposed
research, name, address, and telephone number of the Principal
Investigator, identities of other key personnel and participating
institutions, and number and title of the RFA in response to which
the application is submitted.
 
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the
information that it contains allows the NIDDK staff to estimate the
potential review workload and avoid conflict of interest in the
review. The letter of intent is to be sent to:
 
CHIEF, REVIEW BRANCH
DIVISION OF EXTRAMURAL ACTIVITIES
National Institute of Diabetes, Digestive, and Kidney Diseases
45 CENTER DRIVE ROOM 6AS-37F MSC 6600
BETHESDA, MD 20892-6600
FAX: (301)480-3505
Email: hagana@ep.niddk.nih.gov
 
APPLICATION PROCEDURES
 
Applications must be submitted on the standard research grant
application form PHS 398 (rev. 5/95).  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, E-mail:
asknih@odrockm1.od.nih.gov.
 
The RFA label in the form PHS 398 must be affixed to the bottom of
the face page.  Failure to use this label could result in delayed
processing of the application such that it may not reach the review
committee in time for review.  For purposes of identification and
processing, item 2 of the face page of the application must be marked
"YES" and the RFA number and the words "Interstitial Cystitis
Clinical Trials Group" must be typed in.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies in one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (For express/courier service)
 
At the time of submission, two additional copies of the application
must be sent to:
 
CHIEF, REVIEW BRANCH
DIVISION OF EXTRAMURAL ACTIVITIES
National Institute of Diabetes, Digestive, and Kidney Diseases
45 CENTER DRIVE ROOM 6AS-37F MSC 6600
BETHESDA, MD 20892-6600
 
Applications must be received by August 26,1997.  If an application
is received after this date it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG 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 an application must follow the
guidance in the PHS 398 applications instructions for the preparation
of revised applications, including an introduction addressing the
previous critique.
 
REVIEW CONSIDERATIONS
 
All applications will be judged on the basis of the scientific merit
of the proposed project and the documented ability of the
investigators to meet the RESEARCH OBJECTIVES of the RFA.  Although
the technical merit of the proposed protocol is important, it will
not be the sole criterion for evaluation of a study.  Other
considerations, such as the ability to recruit minority participants
and geographic location, will be part of the evaluation criteria.
 
Upon receipt, applications will be reviewed for completeness by the
DRG and responsiveness by the NIDDK. Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration.
 
Review Criteria
 
Applicants are encouraged to submit and describe their own ideas
about how best to meet the goals of the cooperative study and their
specific protocols. The Initial Review Group evaluates the merit of
each grant application according to specific criteria.  The principal
criteria for the initial review of all research applications, as
required in the PHS Scientific Peer Review Regulations, include:
 
1.  scientific, technical, or medical significance and originality of
the proposed research;
 
2.  appropriateness and adequacy of the experimental approach and
methodology to be used;
 
3.  qualifications of the Principal Investigator and staff in the
area of research;
 
4.  the Principal Investigator's experience and record in previous
research activity;
 
5.  reasonable availability of resources;
 
6.  reasonableness and adequacy of justification of the proposed
budget and duration of support;
 
7.  adequacy of the proposed means for protecting against adverse
effects upon humans, vertebrate animals, or the environment.
 
The evaluation of applications for Clinical Centers and the Data
Coordinating Center will be based primarily on the scientific merit
of the proposed studies.  Specific criteria for review of
applications will be as follows:
 
For Clinical Centers:
 
1.  The scientific merit of the proposed study design(s) to address
the objectives of the RFA.
 
2.  Documentation of the specific competence and previous experience
of professional, technical, and administrative staff pertinent to the
operation of a Clinical Center in the proposed Clinical Trial Group.
Evaluation will include the following: familiarity with and
experience in recruiting participants in a randomized trial; handling
laboratory specimens; working in collaboration with other
investigators under a common protocol; ability to implement study
procedures; and meticulous and expeditious handling of study data.
 
3.  Documentation of access to patient population(s) from which a
substantial number of trial participants can be recruited in
sufficient numbers to meet the goals specified in the RFA.
 
4.  Ability to recruit representative minority populations.
 
5.  Understanding and awareness of the scientific, ethical, and
practical issues underlying the proposed trials and appropriateness
of plans to deal with them.
 
6.  Responsible budgeting and staffing and distribution of available
resources appropriate for the work proposed.
 
7.  Adequacy of the proposed facility and space.
 
8.  Evidence of the degree of institutional commitment and support
for the proposed program, including the relative position of the
proposed project staff within the applicant's organizational
structure.
 
9.  Willingness to carry out a developed study protocol.
 
10.  Adequacy of plans to ensure accurate collection and timely
transmission of study data.
 
For the Data Coordinating Center:
 
1.  The scientific merit of the proposed approach to study design,
data collection and management for interventions as outlined in the
RFA.
 
2.  Documentation of the specific competence and private experience
of professional, technical, and administrative staff pertinent to the
trial.  Prior experience in similar studies, in the collection of
data and patient specimens from multiple locations, as well as
experience in monitoring the quality and timeliness of such data,
should be demonstrated.
 
3.  Demonstrable knowledge of the potential problems associated with
the conduct of this study and possible solutions must be
demonstrated.
 
4.  Suitability of proposed data management and data analysis plans.
 
5.  Ability to design, implement and maintain a distributed data
entry system for the Clinical Centers.
 
6.  The approach to and likelihood of soliciting cooperation from the
participating Clinical Centers and exercising appropriate leadership
in matters of study design and protocol revisions, and data
acquisition, management, and analysis.  Specific plans for ensuring
quality control of data collection across all study sites are
required.
 
7.  Appropriateness of the budget for the work proposed.
 
8.  The adequacy of the proposed facility, technical hardware, and
space.
 
9.  The organizational and administrative structure of the proposed
program.
 
10.  Evidence of the degree of commitment and support of the
organization/institution for the proposed program, including the
relative position of the proposed project staff within the
applicant's organizational structure.
 
AWARD CRITERIA
 
Applications recommended by the National Diabetes and Digestive and
Kidney Diseases Advisory Council will be considered for award based
upon (a) scientific and technical merit; (b) program balance,
including in this instance sufficient compatibility of features to
make a successful collaborative program a reasonable likelihood; (c)
availability of funds; (d) appropriate minority representation in the
trial; and (e) geographic balance among clinical centers.
 
SCHEDULE
Letter of Intent Receipt Date:  July 25, 1997
Application Receipt Date:      August 26, 1997
Special Review Committee:      October/November 1997
NIDDK Advisory Council:        February 4-5, 1998
Anticipated Award Date:        March 1, 1998
 
INQUIRIES
 
Written and telephone Inquiries concerning this RFA are strongly
encouraged.  The opportunity to clarify any issues or questions from
potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
John W. Kusek, Ph.D. or Leroy M. Nyberg, Ph.D., M.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 CENTER DRIVE MSC 6600
BETHESDA, MD 20892-6600
Telephone (301) 594-7717
Email: kusekj@ep.niddk.nih.gov or nybergl@ep.niddk.gov
 
Direct inquiries regarding fiscal and administrative matters to:
 
Trude Hilliard
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 CENTER DRIVE Room 6AN-44B MSC 6600
BETHESDA, MD 20892-6600
Telephone:  (301) 594-8859
FAX:  (301) 480-3504
Email: hilliardt@ep.niddk.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No 93.849.  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 PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  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 work place 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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