Full Text CA-92-21

TRANSFER OF NEW BIOSTATISTIC METHODS TO CANCER EPIDEMIOLOGY

NIH GUIDE, Volume 21, Number 27, July 31, 1992

RFA:  CA-92-21

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Epidemiology 
  Statistics 


National Cancer Institute

Letter of Intent Receipt Date:  September 30, 1992
Application Receipt Date:  November 12, 1992

PURPOSE

The Division of Cancer Etiology of the National Cancer Institute (NCI)
announces the availability of a Request for Applications (RFA) to
stimulate interest in small projects for the transfer of theoretical
biostatistical methodologies to application in cancer epidemiologic
studies.

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,
Transfer of New Biostatistic Methods to Cancer Epidemiology, 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
"Healthy People 2000" (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 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 and women investigators are encouraged.

MECHANISM OF SUPPORT

This program will be supported through National Institute of Health
(NIH) traditional research project grants (RO1).  Responsibility for
the planning, direction, and execution of the proposed research will be
solely that of the applicant.  Awards will be administered under PHS
grants policy as stated in the PHS Grants Policy Statement, DHHS
Publication No. (OASH) 82-50,000 revised October 1, 1990.

The RFA is a one-time solicitation.  The total project period for
applications submitted in response to the present RFA may not exceed
three years.  For competing supplemental applications, if the remaining
length of time on the parent project period is less than three years,
the period of requested supplemental support must be adjusted
accordingly.

Competitive continuation applications will compete with all other
unsolicited applications and be reviewed by Division of Research Grants
(DRG) study sections.  If the NCI determines that there is a sufficient
continuing program need, the NCI may announce a request for renewal
applications.

FUNDS AVAILABLE

Approximately $500,000 in total costs will be committed for the first
year to fund applications that are submitted in response to the RFA.
The intent is to fund 5 to 10 research awards.  The funding level is
dependent on the receipt of a sufficient number of applications of high
scientific merit.  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

A decade or two ago, a biometry textbook, a medical statistics book,
and an understanding of the basic principles of statistics provided
applied biostatisticians with sufficient experimental designs and
methodologic techniques to analyze most problems encountered in cancer
research.  Meanwhile, theoretical statisticians explored statistical
problems of general interest without focussing on specific
applications.  Advances in biotechnology and high-speed computing tools
have driven the development of specialties and even subspecialties in
biostatistics.  Advances have been made in methods for analyzing cancer
survival data, understanding data with missing elements, allowing for
errors in variables, fitting random effects models, and utilizing the
bootstrap and other computationally intensive.  Most of this material
is available only in technical journals and specialized textbooks on
theoretical statistics.

There are strong factors that limit the translation of methodological
theory to applied cancer research.  Theoretical biostatisticians are
usually interested in finding solutions to general problems and
publishing in theoretical journals.  Therefore, there is a need to
facilitate transfer of new methodologies for use by applied
biostatisticians working in cancer epidemiology.

Other

The purpose of this RFA is to stimulate collaborations and interactions
among theoretical and applied biostatisticians, cancer epidemiologists,
computer scientists, and programmers and to promote the introduction of
appropriate theoretical methods to epidemiologic projects in cancer
research.  This initiative proposes to link peer-approved activities to
provide a mechanism for facilitating the transfer of new biostatistical
methodologies to applied biostatisticians and epidemiologists.  The
goal is to ensure the validation and integration of promising new
statistical and computing techniques into epidemiologic studies.
Projects funded by this initiative will lead to substantial cost
savings by developing computer programs and analytical techniques that
can be shared by numerous projects.

This RFA encourages the development of 5 to 10 small projects that will
each provide enough support for one key researcher with expertise in
the application of theory to real-life problems in cancer research,
with appropriate collaborations.  Applicants for these grants will need
to show an in-depth knowledge of the biostatistical literature in the
area they propose and demonstrate the willingness of appropriate
collaborators to provide theoretical input and/or data sets for
methodological testing and exploration.  We especially encourage
research relevant to studies of data sets of breast, ovarian, prostate,
and/or cervical cancer.

This mechanism should permit a range of small projects that might be
used by Master's and Ph.D. level biostatisticians and epidemiologists
to tailor and apply new biostatistical designs or methodology for use
in specific cancer projects.  There are many possible approaches,
including:  (1) biostatistical consultation on an epidemiologic study
that compares the use of conventional statistical procedures to
theoretical methodology of greater applicability to epidemiologic
cancer research and (2) development of an expository application for
cancer research of theoretical statistical methodology from a
dissertation or publication, under the tutorship of the dissertation
advisor or with the collaboration of the publication's authors.  The
projects responsive to the RFA can propose the study of a cancer
epidemiology problem, that is, a potential application, seeking out
possibilities in the theoretical literature, and testing these against
actual data sets, making the results available to the scientific
community, or to look at a theoretical article or a general method,
such as those listed below, developing examples of applications by
testing against real data sets, and developing a public- domain program
or function accessible on university-based electronic bulletin boards
for cancer researchers.

The outcomes of these projects could include published articles on the
translation of methodologic theory into computationally feasible
techniques, presentations at scientific meetings, lecture notes, or
efficient, well- documented, and well-written codes for user-ready
computer programs/functions that can be made available to the
scientific community.  (It is not the intent of this initiative to fund
the development of commercial programs or packages.)  Subjects of
interest include, but are not limited to:

o  Cox regression model
o  Logistic regression model, ordered logistic regression
o  Polychotomous regression model
o  Sequential trials; group sequential trials
o  Multiple endpoints
o  Surrogate endpoints
o  Time-dependent covariates
o  Censored data; left and right truncation
o  Meta-analysis
o  Data augmentation methods (Gibbs, bootstrap and jackknife methods)
o  Martingales:  counting processes in survival analysis
o  Frailties
o  Repeated measures
o  Determination of maximum tolerated dose
o  Surrogate markers of exposure

LETTER OF INTENT

Prospective applicants are requested to submit, by September 30, 1992,
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 is being
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 is helpful in planning for the review of applications.
It allows NCI staff to estimate the potential review workload.  The
letter of intent is to be sent to:

Dr. Marthana C. Hjortland
Extramural Programs Branch
Division of Cancer Etiology
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Suite 535
Rockville, MD  20892
Telephone:  (301) 496-9600

APPLICATION PROCEDURES

Applications are to be submitted on form PHS 398 (rev. 9/91), available
at most institutional business offices and from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of Health,
Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, Maryland
20892, telephone 301/496-7441.  The format and instructions applicable
to research grant applications must be followed.

The RFA label available in the application 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 number and title
of the RFA must be typed on line 2a of the face page of the application
and YES must be checked.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, exact photocopies in one package to the
Division of Research Grants the address below.  The photocopies must be
clear and single-sided.

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

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 838
5333 Westbard Avenue
Bethesda, MD  20892

Applications must be received by November 12, 1992.  If an application
is received after that date, it will be returned without review.  If
the application submitted in response to this RFA is substantially
similar to a research 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 CONSIDERATIONS

Upon receipt, applications will be reviewed initially by the Division
of Research Grants (DRG) for completeness. Incomplete applications will
be returned to the applicant without further consideration.
Preliminary evaluation for responsiveness to the RFA is an NCI program
staff function.  If an application is judged to be nonresponsive, the
applicant will be contacted and given an opportunity to have it
considered along with other unsolicited grant applications.

Applications may be triaged by NCI staff on the basis of relative
competitiveness.  The NCI will withdraw from further competition those
applications judged to be non-competitive for award and notify the
applicant Principal Investigator and institutional official.  Those
applications judged to be competitive will undergo further scientific
merit review.  Those applications that are complete and responsive will
be evaluated in accordance with the criteria stated below for
scientific/technical merit by an appropriate peer review group convened
by the NCI.  The second level of review will be provided by the
National Cancer Advisory Board.

Review criteria for RFAs are generally the same as those for
unsolicited research grant applications.  Those factors considered in
the review include:

o  extend to which application addresses research objectives of RFA;

o  overall scientific merit;

o  quality of collaborations to facilitate transfer;

o  qualifications, research experience, and time commitment of
investigators;

o  adequacy of facilities and resources;

o  cost effectiveness of the application.

The review group will critically examine the submitted budget and will
recommend an appropriate budget and period of support for each scored
application.

AWARD CRITERIA

The earliest anticipated of award is July 1, 1993.

In addition to technical merit, the overall applicability to analysis
of data from cancer research studies will be taken into consideration
in making an award.

INQUIRIES

Written and telephone 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. Marthana C. Hjortland
Extramural Programs Branch
Epidemiology and Biostatistics Program
Division of Cancer Etiology
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Suite 535
Rockville, MD  20892
Telephone:  (301) 496-9600

Direct inquiries regarding fiscal matters to:

Ms. Jean M. Cahill
Supervisory Grants Management Specialist
National Cancer Institute
6120 Executive Boulevard
Executive Plaza South, Suite 243
Rockville, MD  20892
Telephone:  (301) 496-7800, ext. 47

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance, No. 93.393, Cancer Cause and Prevention Research.  Awards
will be 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 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.

.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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