Full Text CA-97-008
 
CLINICAL ONCOLOGY RESEARCH CAREER DEVELOPMENT PROGRAM
 
NIH GUIDE, Volume 26, Number 3, January 31, 1997
 
RFA:  CA-97-008
 
P.T. 34

Keywords: 
  Oncology 
  Clinical Trial 

 
National Cancer Institute
 
Letter of Intent Receipt Date:  March 5, 1997
Application Receipt Date:  April 29, 1997
 
PURPOSE
 
The National Cancer Institute (NCI), through its Cancer Training
Branch, invites applications for Institutional Physician Scientist
program grants that will prepare medical doctors for clinical
research careers in medical oncology, surgical oncology, radiation
oncology and other clinical specialties with a focus on cancer.  The
high level of support and intense activity in basic cancer research
over the past decades have resulted in the rapid growth and
constantly increasing body of knowledge about the molecular biology,
immunology, genetics, and cell biology of cancer.  However, the
clinical application of this knowledge to improve procedures that
benefit cancer patients has not kept pace with the accumulation of
research results.  This RFA is intended to stimulate the recruitment
and research career development of clinicians who will be oriented
and skilled in the translation of basic research results into new
clinical procedures and approaches that are of direct benefit to
cancer patients.
 
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,
Clinical Oncology Research Career Development Program, 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 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Institution:  Applications may be submitted by foreign and 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.
Applicant organizations should have well established research
programs with adequate peer-reviewed grant support and highly
qualified faculty in clinical and basic science departments.
 
Clinical Candidates:  All candidates must be U.S. citizens, nationals
or lawfully admitted permanent residents of the U.S.  All candidates
must currently be physicians holding the M.D. or D.O. degrees.
 
Appointments of clinical candidates to the program should be for a
minimum of two years. A minimum 75 percent effort must be devoted to
the basic/clinical research program.  The remaining 25 percent can be
divided among other clinical and teaching activities only if they are
consonant with the program goals, i.e. the candidate's development
into an independent clinical investigator.
 
Programs: Proposed programs must demonstrate the potential to provide
research career development opportunities in more than one clinical
oncology research discipline (e.g., medical oncology, surgical
oncology, radiation oncology, etc.) i.e., not be limited to a single
discipline.
 
MECHANISM OF SUPPORT
 
Support of this program will be through the National Institutes of
Health (NIH) mentored clinical scientist development program (K12).
Applicants will be responsible for the planning, direction, and
execution of the proposed project.  Awards will be administered under
PHS grants policy as stated in the Public Health Service Grants
Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised
October 1, 1990.
 
If there is a current institutional (T32) National Research Service
Award (NRSA) supporting a clinical or surgical oncology training
program within the same milieu of this proposed institutional
clinical oncology research development program (Kl2), the
relationship between the existing and proposed program must be
addressed (see Special Requirements).
 
This RFA is a one-time solicitation.  Generally, future competitive
continuation applications will compete with all
investigator-initiated applications.  Should the NCI determine that
there is a sufficient continuing program need, a request for
competitive continuation and/or new applications will be announced.
 
FUNDS AVAILABLE
 
Total costs of $3.6 million will be committed to fund applications
submitted in response to this RFA.  It is anticipated that
approximately ten awards will be made.  This funding level is
dependent upon the receipt of a sufficient number of applications of
high scientific merit.  The total project period for an application
submitted in response to this RFA may not exceed five years.  The
earliest feasible start date for the initial awards will be September
1997.  Although this program is provided for in the financial plans
of the NCI, the award of grants pursuant to this RFA is also
contingent upon the availability of funds for this purpose.
 
RESEARCH OBJECTIVES
 
Background Information:  A workshop on "Training in Clinical Research
in Oncology" was held on September 12, 1990 to identify the concerns
and problems facing the clinical oncology community, and to examine
the adequacy of NCI training and career grant mechanisms as well as
institutional research environments for attracting and retaining
physicians in clinical oncology research.  A summary of the workshop
was published in Cancer Research 51: 753-756, 1991. Participants
included 20 clinicians representing a wide geographic distribution of
oncology programs and cancer centers as well as NCI staff. There was
unanimous agreement on the decline in the number of clinical
oncologists pursuing careers in innovative clinical research,
resulting in a shortage of properly trained research clinicians to
translate salient basic research findings to patient populations.
Conversely, interesting clinical observations and problems also need
to be communicated to the basic research laboratory.  In order to
address this deficit in clinical oncology research, NCI initiated a
new program career grant (Kl2) mechanism, and on the basis of
peer-review made a number of awards to excellent clinical departments
and cancer centers to provide greater flexibility in selecting and
sustaining young physicians for the critical three to five year
period during which these physician scientists will learn the skills
needed for the successful transition to their own independently
supported research program.  Because progress has been sufficiently
successful during the initial phase of this project, NCI is
reannouncing this award for competitive peer-review of continuation
and new applications.
 
Goals and Scope:  The objectives of this RFA are to increase the
number of clinical oncologists who are motivated and properly
prepared to: (1) interact and coordinate clinical research activities
with basic research scientists in order to expedite the translation
of basic research information into patient-oriented research; (2)
perform independent clinical research that develops and tests
rational scientific hypotheses based on fundamental and clinical
research findings for improving the medical care of cancer patients;
and (3) design and test innovative clinical protocols and manage all
phases of clinical trial research.
 
These clinical oncology research career development programs should
involve staff and clinical candidates representing at least two
clinical oncology disciplines such as medical, surgical, radiation,
pediatric, and gynecologic oncology.  Programs limited to one
clinical oncology discipline are not responsive to the objectives of
this initiative.  Interaction during these early years of training
might serve to enhance the kinds of coordination and team approach
necessary for optimum cancer patient care.
 
Applicants must propose a program designed to provide clinician
candidates with the research skills  that deal directly with aspects
of cancer detection, diagnosis, prognosis, or treatment of cancer
patients.  It is expected that these clinical oncology career
development programs will include both a didactic component (e.g.
formal courses, lecture series, seminars, and journal clubs) and a
research component that focuses on the skills necessary for
translating basic cancer research results into clinical experiments,
procedures, and trials directly involving cancer patients in a
clinical environment.  For example, it will not be sufficient within
the scope of this initiative to use human cells and other clinical
materials in an isolated basic laboratory setting as the total
research development program. Basic laboratory research experience is
essential but it must be properly integrated with clinical research,
thereby affording the candidate actual experience in the application
of their own basic research to clinical research.
 
The proposed program should have the flexibility to accommodate
clinician candidates with different levels of research competence.
While the end goal of this program is specifically to prepare
physicians for dedicated careers in clinical oncology research and
not basic research, candidates must be or become competent in the
fundamentals of the scientific method, particularly hypothesis
development, experimental design, and biostatistical methods that are
usually gained through a significant hands-on basic research
experience.  The research environment will be a critical factor.  It
should be one where there are active basic/clinical research
collaborations that exemplify a dynamic two-way exchange of
information and ideas between laboratory and clinical scientists.
The research environment should also promote rapid translation of
basic research into clinical testing as well as stimulate new ideas
and laboratory experiments, based on clinical observations and
testing results.  In most cases, candidates would acquire both basic
and clinical research skills that will prepare them to become
dedicated clinical researchers able to interact and communicate
effectively with basic research scientists in the design and
implementation of collaborative research involving patients.  In this
context, it might also be appropriate for the basic scientists to be
involved in the clinical seminars, protocol planning sessions, and
grand rounds.  However, applicants may address these issues in other
creative ways.
 
Applicants should provide a detailed outline of the content and scope
of the program for the career development of clinicians in innovative
clinical oncology research and how it will provide the skills and
experience necessary for the development and testing of new clinical
procedures that will be of direct benefit to cancer patients.
Additionally, applicants should clearly address the following issues:
1) the availability of a research environment that promotes the
interactions and collaborations of clinical researchers and basic
researchers which are necessary for the translation of basic research
results into the clinical arena;  2) the qualifications of the
faculty mentors, highlighting their clinical and basic research
projects and how this research will promote the integration of basic
and clinical research experiences to achieve the overall objectives
of this RFA;  3) the availability of an appropriate mentor for each
candidate who would have responsibility for his/her research program
and day-to-day progress; 4) the procedures to be used to announce the
program and to select appropriate candidates, mentors, and research
projects; 5) the efforts that will be made to evaluate each
candidate's level of research experience and needs and to report on
the progress of each candidate in the program; and 6) the
establishment of an Advisory Committee (see Special Requirements) to
provide an oversight function and annual evaluation of the clinical
research development program as a whole.
 
SPECIAL REQUIREMENTS
 
The principal investigator must establish an Advisory Committee for
this program. Clinical and basic science departments participating in
this program should be represented on the committee by clinical
investigators from the various oncology disciplines such as medical
oncology, surgical oncology, radiation oncology and other oncology
specialties as well as by basic research investigators.  The
committee's responsibilities might include: selecting physician
candidates, assigning preceptors, approving each candidate's clinical
research development plan, evaluating each  candidate's progress, and
monitoring the overall effectiveness of the program.  A detailed
description should be provided of the committee's composition,
function, and frequency of meetings. A detailed report of the actions
of the committee meetings should be provided in the annual progress
report of the grant.
 
Each clinical research candidate should have one or more
preceptor/mentor(s) who are accomplished investigators in their
field.  The advisor(s) should assume responsibility for devising a
career development and research plan with the candidate, obtaining
the concurrence of the program Advisory Committee, and providing
day-to- day advice.
 
Plans for an annual evaluation of the program by the Advisory
Committee should be described.  The Annual Progress Report for the
grant should provide a summary of this evaluation and include a
description of the research and career progress of each candidate,
describing how laboratory and clinical research and practice are
being integrated.  These Annual Reports will be closely monitored by
NCI staff to ensure that the grant is achieving the goals of this
Clinical Oncology Research Career Development Program.
 
Where there already  exists an active institutional (T32) National
Research Service Award (NRSA) supporting a surgical or other clinical
oncology research training program, the applicant must address the
relationship between the existing T32 and proposed K12 programs.  If
there is significant overlap in the programs, the T32 award can be
merged into the K12 program or modified to remove areas of
substantial overlap.
 
ALLOWABLE COSTS
 
In order to provide sufficient diversity and distribution of
programs, direct costs for the (01) year should not exceed $350,000,
and any increases in future year positions should be incremented
gradually over the five year program with appropriate justification.
Peer review will assess the quality of resources available to support
the type of program proposed and the number of positions requested
within the above limitations.
 
Salary:  Clinical research candidates will be provided salary support
of up to $50,000 each year, plus fringe benefits commensurate with
the applicant institution's salary structure for persons of
equivalent qualifications, experience, and rank.  The institution may
supplement the NCI contribution; however, supplementation may not be
from Federal funds unless specifically authorized by the Federal
program from which such funds are derived.  In no case, may PHS funds
be used for salary supplementation.  Institutional supplementation of
salary may not require extra duties or responsibilities that would
interfere with the purpose of this award.  Under expanded
authorities, however, institutions may rebudget funds within the
total costs awarded to cover salaries consistent with the institution
salary scale.  The total salary requested must be based on a
full-time, 12 month staff appointment.
 
Other Expenses:  $20,000 per candidate will be provided annually to
partially support supplies, equipment, travel, tuition and other
costs which are essential for the individual's clinical research
development program.
 
Indirect Costs: Indirect costs will be provided at a rate not
exceeding eight percent of total direct costs of each award,
exclusive of tuition, fees, and expenditures for equipment.
 
Categorical amounts cited above, notwithstanding, the total award may
not exceed $350,000 in direct costs for the first year.
 
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 are
provided that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research.  This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research" which have been published in the
Federal register of March 28, 1994 (FR 59 14508-14513), and reprinted
in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18,
1994.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by March 5, 1997, a
letter of intent that includes a descriptive title of the proposed
program, the name, address, telephone, FAX, and E-mail numbers 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, the information that it
contains allows NCI staff to estimate the potential review workload
and avoid conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Dr. Vincent J. Cairoli
Division of Cancer Treatment, Diagnosis, and Centers
National Cancer Institute
Executive Plaza North, Room 520
Bethesda, MD  20892
Telephone: (301) 496-8580
FAX: (301) 402-4472
Email: VC14Z@NIH.GOV
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications 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 301/710-0267, email:
ASKNIH@odrockm1.od.nih.gov.
 
The completed original application and three legible copies must be
sent to or delivered 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 must also be sent
to:
 
Ms.  Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636
Bethesda, MD  20892-7405
Rockville, MD  20852 (express/courier service)
 
Applications must be received by April 29, 1997.  If an application
is received after that date, it will be returned to the applicant
without review.  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.  An application, therefore, cannot be
submitted in response to this RFA which 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 CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NCI.  Applications that are complete and
responsive to the RFA will be evaluated for scientific and technical
merit by an appropriate peer review group convened by the NCI in
accordance with the standard NIH peer review procedures.  As part of
the initial merit review, all applications will receive a written
critique and undergo a process in which only those applications
deemed to have the highest scientific merit, generally the top half
of applications under review, will be discussed, assigned a priority
score, and receive a second level review by the National Cancer
Advisory Board.
 
Review Criteria
 
The review criteria set forth below are neither exhaustive nor
prescriptive.  Applicants are asked at a minimum, to address each
criterion. Members of the peer review group convened by the NCI
Division of Extramural Activities (DEA) will be requested to use
their best professional judgment in evaluating the educational and
scientific merit of any application under review. The review
criteria, therefore, are more than a guide but less than an absolute
requirement.
 
o  Scientific and administrative leadership qualifications and
experience of the principal investigator.
 
o Qualifications of faculty mentors: adequacy of peer-reviewed
clinical and basic cancer research projects, publications and
training experience in the context of achieving the objectives of
this RFA.
 
o  Recruitment and selection plans for appointees and the
availability of high quality candidates.
 
o  Appropriateness of detailed plans for a comprehensive program to
provide physicians with the proper integration of basic and clinical
research skills and experiences necessary for careers in clinical
oncology research.
 
o  Adequacy of procedures for assessing each candidate's level of
scientific research experience, ability and needs in order to
optimize his/her research career development and as a prerequisite
for clinical research.
 
o  Appropriateness of a research environment that provides
collaborations among clinical and basic research scientists or of
plans to establish and promote such collaborations.
 
o  Adequacy of facilities and other resources.
 
o  Availability of sufficient cancer patient populations and clinical
materials to support appropriate clinical research experiences.
 
o  Adequacy of the membership and functions of the program Advisory
Committee.
 
o  Effective plans for program oversight and evaluation to be
reported in the Annual Progress Report.
 
o Renewal applications: a detailed Progress Report summarizing the
duration of training, accomplishments, and current status of
candidates supported by this program.
 
o  Adequacy of the proposed means for protecting human subjects and
vertebrate animals against hazardous or unethical research procedures
and for protecting the privacy of human subjects.
 
Budget
 
The review group will critically examine the proposed budget and
recommend an appropriate budget for each approved application within
the guidelines stated above.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other scored
applications submitted in response to this RFA.  The following will
be considered in making decisions: quality of the proposed project as
determined by peer review, availability of funds and program
priority.  The NCI will notify the applicant of the National Cancer
Advisory Board's (NCAB) action.
 
INQUIRIES
 
Inquiries concerning this RFA are encouraged. The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Dr. Vincent Cairoli
Division of Cancer Treatment, Diagnosis and Centers
National Cancer Institute
Executive Plaza North, Room 520
Bethesda, MD  20892-7390
Telephone:  (301)-496-8580
FAX:  (301) 402-4472
Email:  VC14Z@NIH.GOV
 
Direct inquiries regarding fiscal matters to:
 
Ms. Sara Stone
Office of Administrative Management
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD 20892
Telephone: (301)-496-7800, ext. 266
FAX: (301)-496-8601
Email: STONES@GAB.NCI.NIH.GOV
 
AUTHORITY AND REGULATION
 
This program is described in the Catalog of Federal Domestic
Assistance Number 93.398, Cancer Research Manpower.  Awards are made
under the 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 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 and contract recipients to
provide a smoke- free workplace and promote the non-use of all
tobacco products.  In addition, Public law 103- 227, the Pro-Children
Act of 1994, prohibits smoking in certain facilities (or, in some
cases, any portion of a facility) in which regular or routine
education, library, day care, health care or early childhood
development services are provided to children.  This is consistent
with the PHS mission to protect and advance the physical and mental
health of the American people.
 
.

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