Full Text CA-94-006


NIH GUIDE, Volume 22, Number 40, November 5, 1993

RFA:  CA-94-006

P.T. 34

  Health, Radiation Effects 
  Health Services Delivery 

National Cancer Institute

Letter of Intent Receipt Date:  December 1, 1993
Application Receipt Date:  January 24, 1994


The Radiation Research Program (RRP), Division of Cancer Treatment
(DCT), National Cancer Institute (NCI) invites applications for
Patterns of Care Studies in Radiation Oncology.  The objective of
this Request for Applications (RFA) is to focus on those factors in
radiation oncology that are most likely to affect patient outcome,
such as failure to control local-regional neoplastic disease,
treatment related morbidity that negatively impacts a patient's
quality of life, or failure to implement new methods and new
treatment strategies that have been shown to be advantageous for the
patient.  While patterns of care studies in the past have focused on
retrospective data, the new concept should address prospective
studies that document patterns of diagnostic methodology, treatment
workup and followup for a variety of tumors.  The purpose of this
research is to identify those variables associated with maximizing
local control, with the goal of increasing survival and minimizing
complications of normal tissues.  An interdisciplinary activity
involving diagnostic imaging, pathology, medical oncology, surgery
and radiation oncology is essential to the goals of this RFA.  New
research projects are likely to result from these studies, such as
new findings that are useful in the design of therapeutic protocols
and in the formulation of clinical and reimbursement policy.


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,
Patterns of Care in Radiation Oncology, is related to the priority
area of cancer.  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 202-783-3238).


Applications may be submitted by domestic and foreign, 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.
Applications from minority individuals and women are encouraged.  In
order to participate in this program, applicant institutions must
demonstrate or meet the following requirements:


1.  Expertise in the design and coordination of multi-disciplinary,
multi-modality clinical studies.

2.  Capacity to develop and implement a methodology for investigating
patterns of care studies that respond to the objectives of this RFA.

3.  Demonstrated experience and expertise in the appropriate
statistical methodology and design of clinical studies so that
statistically valid results are obtained that accurately represent
radiation oncology practice throughout the U.S.

4.  Availability of facilities and professional personnel with
expertise in data collection, management and analysis and the ability
to participate in patterns of care studies to provide centralized
statistical services.

5.  Demonstrated capabilities for monitoring the quality assurance of
the data collection procedures.

6.  Demonstrated capabilities for developing reports, presentations,
scientific manuscripts, workshops, short courses, newsletters and
other methods for the educational and informational objectives of
this RFA.


The administrative and funding instrument to be used for this program
will be the investigator-initiated research project grant (R01).  The
NCI anticipates awarding one to two grants, with total costs not to
exceed $650,000 for the first year.  This RFA is a one-time
solicitation.  Generally, future unsolicited competitive continuation
applications will compete as research project applications with all
other investigator-initiated applications and be reviewed by the
Division of Research Grants (DRG).  However, if there is sufficient
programmatic need, the NCI will invite recipients of awards under
this RFA to submit competitive continuation grant applications for
review according to the procedures of the DRG.  Except as otherwise
stated in this RFA, awards will be administered under PHS grants
policy as stated in the PHS Grants Policy Statement, DHHS Publication
No. (OASH) 90-05,000, revised October 1, 1990.


Approximately $650,000 in total costs per year for three years will
be committed specifically to fund applications that are submitted in
response to this RFA.  The NCI anticipates that one or two awards
will be made.  Although this program is provided for in the financial
plans of the NCI, the award of a grant in response to this RFA is
also contingent upon the availability of funds for this purpose.  The
earliest feasible start date for the initial award will be September
30, 1994.


The major goal of this research initiative is to support clinical
investigations that (1) document and evaluate patient survival and
outcome as a function of radiation oncology practice and methodology,
(2) coordinate with the leadership of the Cooperative Groups
conducting clinical trials for the optimal design of protocols and
clinical research based on data received from patterns of care
studies, (3) examine the patterns of care for minorities vs
non-minorities, and (4) present the findings of the patterns of care
studies to the radiation oncology community to achieve both the goals
of information and education.  The evaluation and documentation of
the acceptance and implementation of new treatment strategies in the
radiation oncology community where a benefit for the cancer patients
has been shown is also of interest.

New studies of interest are prospective patterns of care and/or
patterns of fractionation that will support and enhance on-going
protocols for cancers of the prostate and cervix.  Prospective
studies that show patterns of total care for breast cancer are of
special interest.


The National Cancer Institute has supported patterns of care studies
in radiation oncology since 1973.  The first Patterns of Care Study
(PCS) was accomplished through a grant to the American College of
Radiology (ACR) and was the first nationwide evaluation of a medical
specialty.  A pioneering effort, the PCS has served as a model for
other oncology-related disciplines. The PCS was again funded as a
grant in 1978 and 1983.  Data from these earlier studies provided the
foundation for long-term follow-up of patients treated for cancer of
the prostate, cervix, and Hodgkin's disease.  Significantly, these
studies have shown that the quality of care and the survival of
cancer patients treated with radiation therapy was statistically
related to the treatment "process" (e.g., equipment, personnel, and
diagnostic workup).  By identifying those pretreatment and treatment
factors that are significant to patient survival and outcome in
disease sites where local control and patient outcome could be
improved, previous patterns of care studies have facilitated a
gradual, but significant, improvement in the management of several
cancers, including prostate and cervical cancer and Hodgkin's

New Study

The objective of this RFA is to focus on those factors that are most
likely to affect patient outcome and quality of life, such as failure
to treat and control local-regional neoplastic disease and the
incidence of treatment related morbidity.  Although studies in the
past have focused on retrospective data, prospective studies that
document patterns of diagnostic methodology, treatment workup, and
followup for a variety of anatomical sites with neoplastic disease
are of interest, with a goal of identifying those variables
associated with maximizing local control and minimizing complications
of normal tissues.

Specific projects of interest include prospective patterns of care
studies that coordinate with active protocols of the cooperative
groups in cancers of the prostate and cervix, as well as studies that
show patterns of total care for early stage breast cancer.  Patterns
of care that document differences between minorities and
non-minorities are also of interest, as well as documentation of the
penetration of the results of clinical trials into routine clinical
practice.  Applicants should describe how they plan to coordinate
with active protocols and how they will assess the impact of results
of clinical trials on routine clinical practice.



NIH policy is that applications for NIH clinical research grants are
required to include minorities and women in study populations so that
research findings can be of benefit to all persons at risk of the
disease, disorder or condition under study; special emphasis must be
placed on the need for inclusion of minorities and women in studies
of diseases, disorders and conditions which disproportionately affect
them.  This policy is intended to apply to males and females of all
ages.  If women or minorities are excluded or inadequately
represented in the clinical research of this RFA, particularly in
proposed population-based studies, a clear and compelling rationale
must be provided.

The composition of the proposed study population must be described in
terms of the racial/ethnic group, together with a rationale for its
choice.  In addition, racial/ethnic issues should be addressed in
developing a research design and sample size appropriate for the
scientific objectives of the study. This information should be
included in the form PHS 398 (Rev. 9/91) in Sections 1-4 of the
Research Plan and summarized in Section 5, Human Subjects.
Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans [including American Indians or Alaskan Natives],
Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual policies concerning research on human subjects also apply.
Basic research or clinical studies in which human tissues cannot be
identified or linked to individuals are excluded.  However, every
effort should be made to include human tissue from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
minorities and women in the study design is inadequate to answer the
scientific question addressed and the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in
assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants that do not comply with these policies.


Prospective applicants are asked to submit, by December 1, 1993, a
letter of intent that includes a descriptive title of the proposed
research, the name and address of the Principal Investigator, the
names of other key personnel, the participating institutions, and the
number and title of the RFA in response to which the application may
be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, it is requested
in order to provide an indication of the number and scope of
applications to be reviewed and to avoid conflict of interest in the

The letter of intent is to be sent to Dr. Sandra Zink at the address
listed under INQUIRIES.


Applications are to be submitted on form PHS 398 (rev. 9/91).
Application kits are available from most institutional offices of
sponsored research and may be obtained from the Office of Grants
Information, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
(301) 435-0714.

The RFA label available 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.  In addition, the RFA number and
title must be typed on line 2a of the face page of the application
form and the YES box must be marked.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, exact, clear and single-sided
photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
5333 Westbard Avenue
Bethesda, MD  20892**

At the time of submission, send two additional copies of the
application to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard
Bethesda, MD  20892

Applications must be received by January 24, 1994.  If an application
is received after that date, it will be returned. If the application
submitted in response to this RFA is substantially similar to a grant
application already submitted to the NIH for review, but has not yet
been reviewed, the applicant will be asked to withdraw either the
pending application or the new one.  Simultaneous submission of
identical applications will not be allowed, nor will essentially
identical applications be reviewed by different review committees.
Therefore, an application cannot be submitted in response to this RFA
that is essentially identical to one that has already been reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.


Review Procedure

Upon receipt, applications will be reviewed (initially) by the
Division of Research Grants (DRG) for completeness and responsiveness
by the NCI.  Incomplete applications will be returned to the
applicant without further consideration.  Those applications judged
to be both competitive and responsive will be further evaluated
according to the review criteria stated in the RFA for scientific and
technical merit by an appropriate peer review group convened by the
Division of Extramural Activities, NCI.  The second level of review
by the National Cancer Advisory Board considers the special needs of
the Institute and the priorities of the National Cancer Program.

Review Criteria

1.  Extent to which the application addresses the goals and
objectives of this RFA;

2.  scientific, technical or clinical significance and originality of
the proposed research;

3.  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

4.  the leadership ability of the Principal Investigator and
documented experience in clinical studies;

5.  documented ability of the staff to carry out all the procedures
of data collection, evaluation of evaluability, and quality

6.  statistical support necessary to design, monitor, analyze and
report on the patterns of care studies; and

7.  adequacy of appropriate facilities and resources to support the
research objectives of this RFA.

Reviewers will examine the budget request critically and recommend an
appropriate budget.


The earliest feasible start date for the initial award will be
September 30, 1994, and will be made solely on the basis of peer
review.  Only the most meritorious will be considered, contingent
upon the availability of funds.  Although this program is provided
for in the financial plans of the NCI, a grant award pursuant to this
RFA is contingent upon the availability of funds for this purpose.


Written and telephone inquiries concerning the objectives and scope
of this RFA or inquiries about whether or not specific proposed
research would be responsive are encouraged. The NCI welcomes the
opportunity to clarify any issues or questions from potential

Direct inquiries regarding programmatic issues to:

Dr. Sandra Zink
Radiation Research Program
National Cancer Institute
Executive Plaza North, Suite 800
Bethesda, MD  20892
Telephone:  (301) 496-9360
FAX:  (301) 480-5785

Direct inquiries regarding fiscal matters to:

Ms. Barbara Fisher
Grants Administration Branch
Executive Plaza South, Room 242
6120 Executive Boulevard
Bethesda, MD  20852
Telephone:  (301) 496-7800, Ext. 29
FAX:  (301) 496-8601


This program is described in the Catalog of Federal Domestic
Assistance No. 93.395 (Cancer Treatment Research).  Awards are made
under the authorization of Public Health Service Act, Title IV,
Sections 301, 410 and 411, Part A (Public Law 78-410, as amended by
Public Law 99-158, 42 USC 241 and 285 (a.)) and administered under
the PHS grants policies and Federal Regulations 42 CFR Part 52 and 45
CFR Part 74 and 92.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.


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