Full Text CA-95-008

SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE IN LUNG CANCER

NIH GUIDE, Volume 24, Number 5, February 10, 1995

RFA:  CA-95-008

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Pulmonary Diseases 
  Etiology 
  Diagnosis, Medical 
  Disease Prevention+ 
  Treatment, Medical+ 


National Cancer Institute

Letter of Intent Receipt Date:  March 30, 1995
Application Receipt Date:  June 23, 1995

PURPOSE

The Organ Systems Coordinating Branch of the Division of Cancer
Biology, Diagnosis and Centers (DCBDC) at the National Cancer
Institute (NCI) invites grant applications for Specialized Programs
of Research Excellence (SPORE) in Lung Cancer.  The intent of this
initiative is to expand the number of Lung Cancer SPOREs from the
current two SPOREs to a minimum of three SPOREs through open
recompetition by making awards to those institutions that can conduct
the highest quality balanced translational research approaches on the
prevention, etiology, screening, diagnosis, and treatment of lung
cancer.

SPOREs are at institutions that have made or will make a strong
institutional commitment to the organization and conduct of these
programs.  SPORE applicants will be judged on their current and
potential ability to translate basic research findings into
innovative research settings involving patients and populations.
Each SPORE is encouraged to conduct rehabilitation and
quality-of-life research.  Each SPORE must provide career development
opportunities for new and established investigators who wish to
pursue active research careers in translational lung cancer research;
develop and maintain human lung cancer tissue resources that will
benefit translational research; develop extended collaborations in
critical areas of research need with laboratory scientists and
clinical scientists within the institution and in other institutions;
and participate with other SPORES on a regular basis to share
positive and negative information, assess scientific progress in the
field, identify new research opportunities, and promote inter-SPORE
collaborations to resolve areas of scientific controversy.

Each SPORE and the "network" of SPOREs is expected to conduct
research that will have the most immediate impact possible on
reducing incidence and mortality to human lung cancer.  Each SPORE
should support a mix of basic and clinical researchers whose formal
interactive and collaborative research efforts will result in new
approaches for early detection, diagnosis, therapy, and prevention
and control.  The SPORE mechanism is not intended to support basic
research to the exclusion of clinical research or vice versa.

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,
Specialized Program of Research Excellence (SPORE) in Lung Cancer, 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).

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.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.

To be considered, applicant organizations must have (1) a minimum of
three independent investigators who are successful in obtaining
peer-reviewed research support directly related to lung cancer, and
who together represent experience in both laboratory and clinical
research; (2) access to a patient care and service facility that
serves lung cancer patients and, if the facility is not part of the
parent institution, a statement that assures access to lung cancer
patients for clinical research; the statement must be signed by the
responsible officials of the applicant institution and the consortial
care facility.  Although an application must be submitted by a sole
applicant institution, subcontracted collaborative scientific
arrangements with scientists from other institutions may be included
if these arrangements are clearly delineated, and formally and
officially confirmed by signed statements from the responsible
officials of each institution.  However, a full institutional
commitment must come from the applicant institution.

Support will not be provided for applications with research
activities focused exclusively on basic research, or clinical
research or trials, or epidemiological research.

NCI program staff listed under INQUIRIES should be consulted if there
are questions regarding any of the above eligibility requirements or
exclusions.

MECHANISM OF SUPPORT

Support of this program will be through the specialized center grant
(P50) mechanism.  This mechanism supports any part of the full range
of research and development from basic to clinical and intervention
studies.  The spectrum of activities comprises a multidisciplinary
attack on a specific disease entity or biomedical problem.  These
grants differ from program project grants in that they are more
complex and flexible in terms of the activities that can be
supported.  In addition to support for multidisciplinary research
projects, support is also provided for career development, pilot
research projects, specialized resources and shared core facilities.
Applicants will be responsible for the planning, direction, and
execution of the proposed SPORE program.  Awards will be administered
under PHS grants policy as stated in the PHS Grants Policy Statement.

NCI policy for SPORE grants establishes the following limits to the
requested budgets:  All new and competing renewal P50 SPORE
applications may request a maximum annual direct cost of $1.5 million
and maximum annual total cost of $2.5 million per individual SPORE.
In complying with the direct cost cap of $1.5 million, the indirect
costs related to subcontracts to other institutions or organizations
will not apply toward the direct cost cap, but the total dollar
request may not exceed $2.5 million.  Future year increases are
limited to four percent but may not exceed this cap.  Funding for
successful P50 renewal applications will be for up to five years.
Initial funding for new P50 SPOREs will be for no more than three
years.  Recognizing that the initial three year funding period for
new SPOREs may be too short for several substantive scientific
accomplishments, any future recompetition for this group will be
evaluated on scientific accomplishment and on interim progress in
pursuit of SPORE organizational, collaborative and research
objectives.  This would include, for example, progress toward
planning, developing and implementing new innovative translational
research programs, progress toward developing the careers of new
scientists, progress toward procuring and distributing tissue
specimens, progress toward developing substantive collaborative
interactions.

FUNDS AVAILABLE

This RFA is a one-time solicitation.  The NCI anticipates making at
least three awards.  Applicants applying for competitive renewals may
request up to five years of support.  New applicants or applicants
that have received P20 Lung SPORE feasibility awards in the past may
request up to three years of support.  The NCI anticipates setting
aside $2.5 million per award or $7.5 million total for the initial
year's funding.  Funding in response to this RFA is dependent upon
the receipt of a sufficient number of applications of high scientific
merit.  Although this program is provided for in the financial plans
of NCI, the award of grants pursuant to this RFA is contingent upon
the anticipated availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

Lung cancer is, by far, the leading cause of cancer deaths in the
United States, with an estimated 158,200 deaths in 1994. However, the
incidence rate for lung cancer has begun to decline in men from a
high in 1984.  In women, the rate continues to increase.  Since 1987,
more women have died yearly of lung cancer than of breast cancer.
The scientific information base for lung cancer continues to expand
significantly; however, the application of the information to
clinical and preventive activities is incommensurate with research
advances.  Thus, there is a need to encourage translational research
that would require interdependence between basic and clinical
investigators in the planning and implementation of research.  An
emphasis on translational research would intensify the application of
basic research findings to clinical patients and to populations.

Specialized Programs of Research Excellence (SPORE) must address the
scientific information base and provide focal points for sustaining
and maintaining state-of-the-art research that will contribute to
improved detection, diagnosis, treatment and prevention of lung
cancer.  SPORES will not only be expected to conduct a wide spectrum
of research activities, but also to contribute significantly to the
development of specialized research resources, career development of
new investigators, the development of improved research model systems
and the expansion of the research base through collaborative research
with scientists and clinicians in other institutions locally and
nationwide.  The research supported through this program must have
translational potential or significance.  It will require
interdependence between basic and clinical investigators in planning
and implementing research and would emphasize clinical application of
basic research findings with patients and populations.  Translational
research also applies clinical findings to advance basic research
that ultimately may lead to hypothesis-driven clinical trials or
interventions.  It should be noted that clinical research that is not
based on nor derived from laboratory findings is not considered
translational for purposes of this RFA.

Research Goals and Scope

The goal of this RFA is to expand the current Lung Cancer SPORE
program with the addition of at least one new SPORE. Each SPORE
assembles critical masses of laboratory and clinical scientists to
work together on human lung cancer and to focus on innovative
translation of basic findings into research settings involving
patients and populations.  The ultimate objective is to reduce
incidence and mortality, and to increase and improve survival to the
disease.  The essential characteristics of a SPORE include (1) a
strong scientific program that will have a clear impact on the human
disease, (2) a strong innovative developmental or pilot research
program that can respond quickly to new research opportunities, (3) a
strong career development program to develop and expand the
scientific cadre of investigators dedicated to translational research
on human lung cancer, (4) a human lung cancer tissue procurement
resource, and other resources specifically dedicated to translational
research objectives, and (5) a willingness and commitment to work
with other SPOREs and scientists in order to maximize research
progress.

The special features of SPORE grants provide opportunities for
investigators with mutual or complementary interests to engage in
multidisciplinary research that will impact on prevention, diagnosis
or treatment of human lung cancer, as well as rehabilitation or
quality of life.  Individual research projects must be highly
interactive, and must be conceived, planned and implemented through
the multidisciplinary interactions of independent laboratory and
clinical scientists.  Such interactions should demonstrate the
potential for accelerating the translation of research findings into
practical benefits for patients and populations.  A distinguishing
feature of a SPORE P50 grant is the highly dependent nature of the
research objectives upon intra- and inter-project interactions.
Thus, each project may, but ordinarily would not, be expected to
stand on its own in the absence of interactions with other research
projects.

Developmental research funds provide support for highly innovative
pilot projects that take maximum advantage of new research
opportunities.  This provides a flexible means for responding quickly
to new research opportunities.  Career development of new and
established investigators will generate a cadre of scientists who
could leave the SPORE with research experience to develop independent
lung cancer research programs that emphasize translational research
objectives.

In order to facilitate achievement of SPORE program goals, each SPORE
must develop resources specialized for lung cancer research
activities.  This must include human lung cancer tissue collection
for research activities of the SPORE and for use by scientists who
are concentrating on translational research within and outside the
parent institution.  The development of additional resources
specialized for lung cancer research is also encouraged.

Interactions among SPOREs is an important objective of this
initiative.  This may be in the form of research collaborations,
exchange of scientists on a visiting basis, exchange of resources and
materials, and other innovative ways.  A requirement for all SPOREs
is an annual meeting coordinated by the Organ Systems Coordinating
Branch of the NCI.  The purpose of the meeting is to share scientific
information, assess scientific progress, identify new research
opportunities, and establish priorities that will accelerate the
translation of basic research findings to applied settings in
patients and populations.

SPECIAL REQUIREMENTS

Each SPORE must include the following elements:

1.  A strong institutional commitment.  An institution receiving this
award should incorporate the SPORE high within its institutional
priorities.  The institution should demonstrate a strong commitment
to the program's stability and success.  The application must provide
a plan that addresses how the institutional commitment will be
established and sustained, how it will maintain accountability for
promoting scientific progress, and how the SPORE research effort will
be given a high priority within the institution relative to other
research efforts.  This institutional commitment may be in the form
of commitments to recruit scientific talent, provision of
discretionary resources to the SPORE director, faculty appointments
for SPORE investigators, assignment of research space, cost sharing
of resources, or other ways to be proposed by the applicant.

2.  A qualified principal investigator.  A leader should be selected
as principal investigator who can oversee and conduct planning
activities, provide direction to the SPORE, and ensure a
translational research emphasis.

3.  A substantive lung cancer patient population.  Each SPORE should
be recognized as a leading program in the treatment of lung cancer.
The grant application must demonstrate and document access to a
patient population that can participate in and can benefit from the
innovative clinical and population research activities of the SPORE.

4.  Research projects.  Each SPORE application must include at least
three approved research projects, which together represent reasonably
diverse experimental approaches.  Each research project must be
headed by basic and clinical co-investigators.  It is not necessary
that both co-investigators commit equal effort to the project, but it
should be evident from this collaboration that translational research
objectives will be accelerated.  The research must be oriented toward
the most critically needed areas of lung cancer research, and toward
translational activities that address new innovative possibilities in
lung cancer research.  As indicated above, each project must involve
multidisciplinary laboratory and clinical interaction in the
conception, planning, design and implementation of research.
Projects should be interactive with each other whenever possible.
This program will not support basic research that is without
translational potential or significance nor will it support clinical
studies that are not "translated" from basic research.

Research components involving clinical trials must include provisions
for rigorous data management, quality assurance, and auditing
procedures.  Funds should be budgeted for these activities and should
appear as a separate budget page in the application.  They should not
duplicate internal review and monitoring systems that are already in
place at the institution.  For any treatment protocols supported
directly or indirectly by the SPORE, copies of Informed Consent
forms, Early Stopping rules and procedures to detect and monitor
Adverse Drug Reactions (ADR) must be provided in the application, or
in the case of future protocols, to the NCI program director.

At least one research project must be on lung cancer prevention or
early detection and screening.  The NCI is particularly interested in
early detection and screening efforts.  There is also a strong
interest in developing genetic methods for determining high risk to
lung cancer either through inheritance or through environmental
exposures.  However, the NCI is open to all novel innovative
approaches to prevention.

Collaborative arrangements within the SPORE, within the parent
institution and with other institutions are encouraged.
Collaborations with scientists outside the immediate SPORE should be
documented with appropriate letters of commitment as applicable.
Collaborations with other institutions may involve subcontracting
arrangements but an award will be made to one institution only; that
institution is expected to demonstrate the full institutional
commitment noted in 1. above.

It is expected that all SPOREs will have a balanced approach to lung
cancer that encompasses the areas of prevention, etiology, screening,
diagnosis and treatment.  This balanced approach may be either
through research being conducted in their institution, or through
collaborative associations they have developed or plan to develop
with other SPOREs or with other investigators in the biomedical
research community.

5.  Developmental Research Funds.  Each SPORE should continually
allocate a significant proportion of its budget and effort to pilot
projects that explore innovative ideas.  It is important that SPOREs
use developmental funds to stimulate projects that take maximum
advantage of new research opportunities.  Pilot projects may be
collaborative among scientists within one or more SPOREs, or with
scientists outside the SPORE environment.  The SPORE application
should propose an institutional review process that selects pilot
projects for funding which represent the most innovative ideas and
which are likely to have the greatest impact on reducing lung cancer
incidence and mortality, and increasing and improving survival and
quality-of-life of lung cancer patients.  These funds are intended to
remain flexible and to support feasibility and pilot studies of a
limited duration, e.g., two years or less, rather than the duration
of the entire grant period.  The expectation is that successful
feasibility studies will become fully developed projects within the
SPORE, or funded through other forms of research support, e.g., R29,
R01.

6.  Specialized Resources.  The SPORE is encouraged to develop and
maintain resources of special significance to translational lung
cancer research.  While all types of resources may be proposed, each
SPORE must have a dedicated activity for collecting and distributing
human lung cancer tissue.  Tissue collection should include the
essential pathologic and clinical information needed for conducting
research.  This resource should benefit the specific research
activities of the SPORE as well as the research activities of other
scientists within and outside of the parent institution who are
concentrating on translational research issues.  The SPORE must be
willing to participate in any national prioritization for
distribution of tissues through NCI supported tissue networks.  A
plan must be proposed for prioritizing distribution of tissues and
animal models to SPORE scientists and others based on the most
innovative ideas in translational lung cancer research.  This plan
should be flexible enough to accommodate and complement broader
national priorities as they are developed.

7.  Career Development.  The SPORE should demonstrate a consistent
commitment to career development.  A sufficient portion of the budget
should be dedicated to the salaries and research activities of
investigators who wish to pursue careers in translational research on
lung cancer and who would acquire the necessary research experience
to develop independent lung cancer translational research programs
within or outside of the parent institution.  These may be new
investigators or established investigators who wish to change
research directions.  Candidates should be scientists who have
demonstrated outstanding research potential but who need additional
time in a productive scientific environment to establish an
independent lung cancer research program.  Candidates are expected to
devote full time to research.  Any deviation will require prior NCI
approval.  Recruitment should encourage the participation of
qualified women and minorities where possible.  To this end, each
applicant should include a clear policy and plans for recruiting
minorities and women.  The SPORE application should propose the
number of slots available, the criteria for eligibility and for
selection of candidates, and describe the selection process.  Also,
the application should indicate prospective mentors who are already
in place at the proposed SPORE, briefly describe their research
programs, and describe complementary activities that contribute to
the environment for career development (e.g., existing training
grants, other career development mechanisms and relevant programs).

8.  Annual Meeting of SPORE.  Investigators participating in Lung
Cancer SPOREs will be expected to participate in an annual meeting
with the Organ Systems Coordinating Branch of the NCI to share
positive and negative results with other SPOREs, share materials,
assess progress, identify new research opportunities, and establish
interactions and research priorities and collaborations that will
maximize the impact of the research on reducing incidence and
mortality, and improving survival.  Travel funds for the Principal
Investigator and selected Project Investigators may be budgeted for
this purpose.  This may include Project Investigators from other
institutions who are actively collaborating with SPORE investigators.
In addition, travel funds should be budgeted for the SPORE Director
to attend an annual SPORE Directors' administrative and planning
meeting at the NCI.  This Directors' meeting is in addition to the
annual SPORE Investigators' meeting.

A SPORE application can originate from an institution with or without
an existing NCI Cancer Center Support Grant or P30 core grant.
However, if a P30 grant already exists:

a.  the Principal Investigator of the SPORE should be a senior leader
in the cancer center;

b.  the P30 Center Director may be the Principal Investigator of the
P50 SPORE, but this is not necessary;

c.  lines of authority should be indicated clearly such that the
SPORE is an integral part of the Cancer Center and does not interfere
with the P30 chain of authority;

d.  a letter of commitment which delineates organizational
relationships and lines of authority is required; the letter must be
signed by the proposed Principal Investigator of the SPORE, the
Cancer Center Director and the appropriate institutional official;

e.  the SPORE must be an integrated major programmatic element in the
cancer center; however, there must also be a separate and distinctive
institutional commitment to the SPORE as opposed to the
NCI-designated Cancer Center;

f.  the development of resources in the SPORE should not duplicate
resources already provided by the existing P30 grant; however, SPORE
resources can be used to augment existing center resources to orient
these resources more effectively to SPORE research objectives if this
is a more efficient and more cost effective alternative;

g.  the applicant should describe how the P50 SPORE will interact
synergistically and effectively with the existing P30 programs in
order to maximize SPORE research objectives and contribute to cancer
center research objectives.

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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research," which was reprinted in the Federal
Register of March 28, 1994 (FR 59 14508-14513) to correct typesetting
errors in the earlier publication, and reprinted in the NIH GUIDE FOR
GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed below.  Program staff may also
provide additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 30, 1995, a
letter of intent that includes the name, address, and telephone
number of the principal investigator and identifies the component
research projects, core units and their principal investigators, any
collaborating 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, the information that it
contains allows NCI staff to estimate the potential review workload
and to avoid conflict of interest in the review.  Furthermore, NCI
staff can discuss the most recent policies of the NCI relative to
funding issues, potential problems in meeting eligibility
requirements or clarification of the peer review process before the
final application is submitted.

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

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, Westwood Building, Room 449, Bethesda, MD 20892-4500,
telephone (301) 435-0714; and from the NCI Program Director listed
under INQUIRIES.

Specific instructions for preparing a SPORE grant application are
available from the program staff listed under INQUIRIES.  These
instructions must be used in preparing the application.

The RFA label available in the PHS 398 (rev. 9/91) 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 "SPORE in Lung Cancer" 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 photocopies, in one package to:

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040
Bethesda, MD  20892
Bethesda, MD  20817 (express mail)

At the time of submission, two additional copies of the application
must be sent to:

Ms. Toby Friedberg
Division of Extramural Activities,
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard MSC 7405
Bethesda, MD  20892
Rockville, MD 20852 (express mail)

It is important to send these copies at the same time that the
original and three copies are sent to the Division of Research Grants
(DRG); otherwise, the NCI cannot guarantee that the applications will
be reviewed in competition with other applications received by the
receipt date.

Complete applications must be received by June 23, 1995.  If an
application is received after that date, it will be returned to the
applicant without review.  The DRG will not accept any application in
response to this RFA that is essentially the same as one already
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.
Applications must meet all eligibility requirements as described
above and must address all programmatic requirements (see SPECIAL
REQUIREMENTS above) in the RFA.  Applications received after this
date will not be accepted.

REVIEW CONSIDERATIONS

A.  Review Procedures

Upon receipt, applications will be reviewed initially by the Division
of Research Grants for completeness.  Incomplete applications that
have not addressed all of the required elements noted under SPECIAL
REQUIREMENTS or do not meet the ELIGIBILITY REQUIREMENTS, will be
returned to the applicant without further consideration.  Evaluation
for responsiveness to the program requirements stated in the RFA is
an NCI program staff function; this will be done stringently and will
be based primarily on the clear orientation of the application to
human lung cancer and translational research objectives.
Applications judged to be non-responsive to this RFA will be returned
without review.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit and for special SPORE
characteristics and requirements by an appropriate peer review group
convened by the NCI in accordance with the review criteria stated
below.  As part of the initial merit review, a process (triage) may
be used by the initial review group in which applications will be
determined to be competitive or non-competitive based on their
scientific merit relative to other applications received in response
to the RFA.  Applications judged to be non- competitive will be
withdrawn from further consideration and the principal
investigator/program director and the official signing for the
applicant organization will be promptly notified.  Applications
judged to be competitive will be discussed and be assigned a priority
score.  The second level of review will be provided by the National
Cancer Advisory Board.

B.  Review Criteria

The major factors to be considered in the evaluation of all
applications are given below.  Additional factors are noted in a
separate section below for applications from existing P20 Lung SPORE
feasibility grantees and for applications from P50 SPOREs applying
for competitive renewal.

1.  The Institutional Commitment

a.  adequacy of facilities, equipment and space to promote
translational research objectives;

b.  adequacy of institutional procedures and plans for monitoring,
evaluating and assuming accountability for the general success of the
SPORE; adequacy of the institutional infrastructure for assessing
progress and needs;

c.  adequacy of recruitment objectives and plans to strengthen the
scientific capabilities of the SPORE;

d.  presence of other tangible commitments, i.e., discretionary
resources, to the SPORE, e.g., dollars and space.

2.  Overall Program Organization and Capability

a.  the scientific qualifications and demonstrated scientific and
administrative leadership capabilities of the SPORE Principal
Investigator; adequacy of the time commitment of the Principal
Investigator;

b.  the depth and breadth of the proposed research activities and
plans to effectively pursue translational research objectives;

c.  the adequacy of access to patients and to a population for
conducting current and projected therapeutic, prevention and control
research;

d.  the adequacy of the procedures, processes, and plans for
promoting interactions;

e.  if applicable, the adequacy of plans for synergistic and
effective interactions with existing P30 programs.

3.  Individual Research Projects

a.  qualifications and demonstrated competence of the investigators
to conduct the proposed research; the adequacy of the time commitment
of all key laboratory and clinical researchers associated with the
project;

b.  clear evidence of significant multidisciplinary basic and
clinical interactions in the conception, design and proposed
implementation of the project;

c.  degree to which the project addresses an issue of substantive
importance for reducing incidence and mortality or for increasing
survival in human lung cancer;

d.  the scientific merit and adequacy of experimental design of the
project;

e.  in clinical research components, clear evidence of full
protection of human subjects, and appropriate mechanisms for the
rigorous management and verification of research data;

f.  the adequacy of quality assurance and audit processes, and
related budget for research involving clinical trials;

g.  the originality, novelty, and innovativeness of the experimental
design and relevance to the overall goals and objectives of the
SPORE;

h.  the degree to which the project is interactive with other
projects in the SPORE conceptually, experimentally, and
translationally;

i.  appropriateness of the budget to achieve research objectives.

j.  Adequacy of plans to include both genders and minorities and
their subgroups as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects will
also be evaluated.

4.  Developmental Funds

a.  adequacy of the proposed process for continuously reviewing and
funding pilot projects for their quality, innovativeness and
potential impact on reducing incidence and mortality, and/or
improving survival to lung cancer;

b.  quality, innovativeness and potential impact of proposed pilot
projects;

c.  degree to which developmental funds will be used to stimulate
pilot projects with multidisciplinary interactions and/or
collaborative interactions with other scientists within or outside of
the parent institution;

d.  appropriateness of the proposed budget relative to the proposed
pilot projects and potential of the program to generate innovative
pilot projects on a consistent basis.

5.  Career Development

a.  the adequacy of the process for selecting candidates for career
development who demonstrate potential for independent research
careers or who are established investigators and are changing the
direction of their research careers;

b.  adequacy of the policies to seek out and include qualified
minorities and women in the career development program;

c.  adequacy of the individuals available in the program to serve as
possible mentors of career development candidates; the current
availability and adequacy of projects for career development
candidates;

d.  complementary activities that contribute to the environment for
career development;

e.  capacity of the overall program to absorb career development
candidates and prepare them for independent lung cancer research
careers;

f.  appropriateness of the budget relative to the proposed plans for
sustaining a strong activity in career development.

6.  Shared Resources

a.  adequacy of the proposed plans to develop, maintain and
distribute a fresh/frozen human lung cancer tissue resource with
pathological and clinical data;

b.  willingness to participate in any national prioritization for
distribution of tissues through NCI-supported tissue networks;

c.  adequacy of the proposed plans to develop, improve, and
distribute animal models;

d.  confirmation that the plan does not duplicate resources already
available within the institution (e.g., as part of a Cancer Center
Support Grant or P30) or through readily available national
resources;

e.  adequacy of the justification for other specialized resources
essential for the conduct of SPORE research;

f.  adequacy of qualifications of proposed managers of resources to
conduct  high quality, reliable resource operations;

g.  appropriateness of the requested budgets to conduct each resource
operation.

7.  Interactions with other SPOREs

a.  adequacy of plans to promote and maintain communication and
integration with other lung SPOREs;

b.  willingness to interact with other SPOREs and with the NCI in
sharing information, in assessing scientific progress, in identifying
new research opportunities and in establishing scientific priorities.

The above criteria apply to all new and competing applications.
Additional factors to be considered in the evaluation of competing
applications from P20 Feasibility SPORE grantees, will be:

a.  nature and quality of planning in the context of focusing on
translational activities;

b.  extent to which applied researchers (e.g., clinical researchers,
prevention and control researchers) are interacting with basic
investigators in planning translational approaches to the problem of
lung cancer;

c.  how funds have been used to foster planning for a SPORE in lung
cancer;

d.  positive and/or negative results of pilot projects, if
applicable.

e.  extent to which pilot projects, where applicable, have led to
proposal of new full research projects in the current grant
application.

Additional factors to be considered in the evaluation of competing
renewal applications from current P50 SPORE grantees, will be:

1.  Research Projects

a.  progress in establishing a high quality research effort and
scientific productivity in translational research over the previous
funding period;

b.  degree to which applied researchers (e.g., clinical researchers,
prevention and control researchers) are interacting with basic
investigators in the planning, design, and implementation of research
projects;

c.  collaborative efforts that have been established within and
outside the SPORE institution;

d.  results (positive or negative) from each research project;

e.  degree to which each project is interacting with other projects;

f.  translational potential or significance of each individual
research project;

2.  Developmental Projects

a.  progress in the effective use of developmental funds to explore
new research opportunities and/or stimulate the field;

b.  quality, innovativeness, and potential or actual impact of funded
pilot projects;

c.  positive and/or negative results for each developmental project;

d.  how the SPORE has set priorities in the use of developmental
funds;

e.  impact of developmental projects in stimulating new full
translational research projects within the SPORE, or through other
support mechanisms;

f.  impact of developmental projects in stimulating new
multidisciplinary or collaborative interactions within or outside the
SPORE.

3.  Career Development

a.  progress toward recruiting candidates including women and
minorities, for career development;

b.  progress in developing the careers of new or established
investigators in translational lung cancer research;

c.  quality and adequacy of the research activities of these
individuals;

d.  current status and research activities of individuals who have
completed career development, if applicable.

4.  Shared Resources

a.  effectiveness and efficiency of previously funded resources in
meeting the specific translational research needs of the scientific
projects in the SPORE;

b.  extent to which shared resources are being used by research and
pilot projects, both within and outside the SPORE;

c.  quality, utility, and efficiency of the shared resources;

d.  progress toward establishing the lung cancer tissue resource to
include pathological and clinical data; nature, quality, and
distribution of tissues being procured; plans for prioritizing
distribution of tissues within and outside the SPORE;

5.  Other Considerations

a.  special efforts to recognize unique research opportunities based
on incidence and mortality rates in the community or region of the
SPORE;

b.  special efforts to enhance the research capability of the SPORE
through interactions with individuals, organizations, and
institutions within the community;

c.  special efforts to promote and maintain communication and
integration with other lung SPOREs;

d.  progress toward meeting previously stated (above) institutional
commitments;

e.  demonstrated effectiveness of the SPORE Director in terms of
scientific and administrative leadership;

f.  progress in refining and improving upon the translational
research infrastructure of the SPORE during the previous funding
period as it relates to a. through e. above.

C.  Scoring the Applications

In addition to rating the merit of individual components, peer
reviewers will be asked to judge the overall program in the following
areas:

1.  scientific merit and innovativeness;  progress, if applicable;
2.  evidence of interdependent, multidisciplinary design and conduct
of the research;
3.  impact, or potential for impacting on the disease;
4.  institutional commitment.

A verbal descriptor will be recorded for each of the above areas.

AWARD CRITERIA

The earliest anticipated date of award is April 1, 1996. Applications
considered by the National Cancer Advisory Board will be considered
for award based upon (a) priority score, (b) programmatic priorities,
and (c) availability of funds.  The NCI anticipates making at least
three awards for project periods of five years for successful P50
competitive renewals, and for project periods of three years for
applications from new applicants or current P20 Lung SPORE
feasibility grantees applying for P50 funding.

INQUIRIES

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

For inquiries regarding programmatic issues, contact:

Andrew Chiarodo, Ph.D.
Division of Cancer Biology, Diagnosis, and Centers
National Cancer Institute
Executive Plaza North, Suite 512
6130 Executive Boulevard  MSC 7386
Bethesda, MD  20852-7386
Telephone:  (301) 496-8528
Email:  chiarodoa@dcbdcep.nci.nih.gov

For fiscal or administrative matters, contact:

Joan Metcalfe
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard  MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800  ext. 228

AUTHORITY AND REGULATIONS

This program is described in the catalog of Federal Domestic
Assistance No. 13.397.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410 as
amended: 42 USC 241 and 285 ) and administered under PHS grant
policies and Federal Regulations 42 CFR Part 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 recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.
This is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.

.

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