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Full Text PA-95-069


NIH GUIDE, Volume 24, Number 20, June 2, 1995

PA NUMBER:  PA-95-069

P.T. 34

  Risk Factors/Analysis 
  Data Management/Analysis+ 

National Cancer Institute


The Division of Cancer Prevention and Control (DCPC), National Cancer
Institute (NCI), invites investigator-initiated grant applications
for research to investigate the utility of health claims information
as a reporting source for measuring the national cancer burden.
Utility is defined in terms of the completeness and accuracy of the
health claims information to estimate population-based cancer
incidence and survival rates, patterns of care, the role of cancer
risk factors and effects of cancer therapies.  Responses to this
program announcement (PA) would initiate mechanisms to develop the
capabilities of obtaining registry and related health claims-based
data, develop algorithms for matching data as appropriate, develop
mechanisms for protecting the privacy of individuals contained in the
various databases, and develop methodologies for addressing the
research objectives in this PA.


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 PA,
Cancer Surveillance Using Health Claims-Based Data Systems, is
related to the priority area of cancer surveillance and data systems.
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, for-profit and non-profit,
public and private organizations, such as universities, colleges,
cancer centers, hospitals, 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.  Since this PA concerns
surveillance research in the United States, a domestic application
may not include an international component.


Support of this program will be through the National Institutes of
Health (NIH) research project grant (R01).  Applicants will be
responsible for 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.


The objectives of this PA are to encourage investigators to submit
applications to investigate the utility of health claims information
as a reporting source for measuring the national cancer burden.
Utility is defined in terms of the completeness and accuracy of the
health claims information to estimate population-based cancer
incidence and survival rates, patterns of care, role of cancer risk
factors and effects of cancer therapies.  Examples of research
questions that could be addressed concerning the use of health claims
information include, but are not limited to, the following:

1.  How do cancer incidence rates generated from health claims-based
system or other medical contact data compare with cancer registry
rates, such as the Surveillance, Epidemiology and End Results (SEER)
Program rates, including temporal trends in the rates? Are any
differences systematic in nature?  How do rates for diagnostic
variables, such as stage of diagnosis, type of treatment, etc
compare?  Which cancer sites yield reasonable estimates and which do

2.  Do comparisons of data collected by health claims-based systems
versus registries differ depending on the reimbursement system
(fee-for-service claims vs. "managed care.")?  Can techniques of
artificial intelligence (AI) be used to define cases, determine
matches between data sources, determine extent of disease, and other
relevant surveillance data using information from health claims and
other non-registry data?  Can the validity and reliability of data
from various sources be established?

3.  How can health claims-based data systems be used to track the
emergence of new technologies for detecting, diagnosing, or treating
cancer or pre-cancerous conditions?  Can these data be used to
develop an evaluation of the introduction of health care innovations
related to cancer?

4.  How can health claims-based data systems contribute to the
identification of environmental causes of cancer, such as
occupational cancers?

5.  To what extent do health claims-based data systems provide
information of additional value compared to nationwide cancer
mortality data obtainable from the National Center for Health
Statistics?  To what extent do minority populations represent a
special challenge or advantage to the use of health claims databases?

Other issues to be addressed in regard to the above questions include
the identification of data that are currently unavailable from a
cancer registry, such as SEER, that are available in health
claims-based data systems, the identification of barriers including
cost that must be overcome to add health claims data to registry
data, and the identification of questions concerning health services
research and cancer surveillance that cannot be addressed without
health claims data, such as costs considerations. Use of health
claims-based systems to identify cancer burdens in special
populations, such as minority populations (blacks, Hispanics, Native
Americans, Native Alaskans, Asian Americans and Pacific Islanders)
and the underserved (low-income groups, blue-collar groups) is
encouraged.   Also, the confidentiality issues associated with the
use of claims-based data, as well as any other databases proposed,
should be addressed in regard to any of the above questions.


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 too 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
provisions that are substantially different from the 1990 policies.

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, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.


Applications are to be submitted on the grant application form PHS
398 (rev. 9/91) and will be accepted at the standard application
deadlines as indicated in application kit.  Application kits are
available at most institutional offices of sponsored research and may
be obtained from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, 6701 Rockledge Drive,
Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone (301)
710-0267.  The title and number of the program announcement must be
typed in line 2a on the face page of the application.

The completed original application and five legible copies must be
sent or delivered to:

6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD 20817  (for courier/overnight mail service)


Applications will be assigned on the basis of established PHS
referral guidelines.  Applications will be reviewed for scientific
and technical merit by the study sections of the Division of Research
Grants, NIH (or by the review group of the relevant Institute,
Center, or Division), in accordance with the standard NIH peer review
procedures.  Following scientific-technical review, the applications
will receive a second-level review by the appropriate national
advisory council.

Review Criteria

o  scientific, technical, or medical significance and originality of
proposed research;

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

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  availability of resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research;

o  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

The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.


Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
decisions:  quality of the proposed project as determined by peer
review, availability of funds, program priority.


Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.

Direct inquires regarding programmatic issues to:

Kenneth C. Chu, Ph.D.
Special Populations Studies Branch
National Cancer Institute
Executive Plaza North, Room 240
Bethesda, MD  20892
Telephone:  (301) 496-8589
FAX:  (301) 496-8576
Email:  kc10d@nih.gov

Benjamin Hankey, Sc.D.
Surveillance Program
National Cancer Institute
Executive Plaza North, Room 343
Bethesda, MD  20892
Telephone:  (301) 496-8510
FAX:  (301) 402-0816
Email:  hankeyb@dcpcepn.nci.nih.gov

Direct inquiries regarding fiscal matters to:

Kathleen Shino
Grants Management Branch
National Cancer Institute
Executive Plaza South, Suite 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 248
FAX: (301) 496-8601


This program is described in the Catalog of Federal Domestic
Assistance No. 93,399.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74; and 45 CFR part 92.  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 routing 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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