ECONOMIC STUDIES IN CANCER PREVENTION, SCREENING AND CARE

Release Date:  November 12, 1998

PA NUMBER:  PA-99-014

P.T.

National Cancer Institute
Agency for Health Care Policy and Research
National Institute of Dental and Craniofacial Research

PURPOSE

This PA replaces PA-94-011, which was published in the NIH Guide for Grants
and Contracts, Vol. 22, No. 40, November 5, 1993.

The Division of Cancer Control and Population Sciences (DCCPS), National
Cancer Institute (NCI), the Agency for Health Care Policy and Research
(AHCPR), and the National Institute of Dental and Craniofacial Research
(NIDCR) invite investigator-initiated grant applications for research directed
at increasing the knowledge base in the area of the economic aspects of cancer
prevention, screening and care.  The goal of this program announcement is to
generate new economic knowledge that will promote the optimal design of cancer
prevention and control trial studies and interventions and will facilitate the
formulation of effective health care policy related to cancer prevention and
control.  NIDCR has an interest in economic and health services studies as
these relate specifically to oral and pharyngeal cancers and health care
policies related to prevention and control of oral cancers.  This initiative
requests research applications on new methods development, the synthesis and
extension of existing methods, and innovative data gathering strategies. 
Applications that propose to implement actual data collection on a pilot or
full-scale basis as well as analytical studies that use existing data and
methodology will be entertained.

This Program Announcement (PA) relates to the general health services and
outcomes and effectiveness research supported by the AHCPR for a wide range of
clinical conditions, including cancer.  For example, AHCPR is presently
supporting research that supports improvements in health outcomes; strengthens
quality measurement and improvement; identifies strategies to improve access,
foster appropriate use, and reduce unnecessary expenditures; and methodologic
advances in health services research, especially cost-effectiveness analysis. 
Related research priorities are described in AHCPR Health Services Research
Program Announcement PA-98-049, which is available on the WEB at: 
http://www.ahcpr.gov/fund/98049.htm

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 PA, Economic Studies in Cancer
Prevention, Screening and Care, is related to the high priority research needs
of cancer control science.  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

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.

MECHANISM OF SUPPORT

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.

RESEARCH OBJECTIVES

Background

There is increasing interest in the collection and analysis of valid, accurate
and reliable economic data related to specific disease entities and
preventive, screening and treatment intervention related to specific disease
entities.  For example, the 1998 Institute of Medicine report on Scientific
Opportunities and Public Needs: Improving Priority Setting and Public Input at
the NIH (See http://www.nap.edu/readingroom/books/nih/) recommends that, "In
setting priorities, NIH should strengthen its analysis and use of health data,
such as burdens and costs of diseases, and of data on the impact of research
on the health of the public."  The DHHS panel on cost effectiveness in health
and medicine (As summarized in Gold MR, et al.  Cost Effectiveness in Health
and Medicine.  Oxford University Press, 1996) recognized that for purposes of
health care program and policy evaluation economic data on diseases and health
care interventions must go beyond the type of aggregate data needed for cost
of disease studies to include longitudinal data on direct medical costs as
well as data on time and productivity costs related to diseases and health
care interventions. For example, recent FDA approval of new agents applicable
in dental office-based screening for precancerous lesions or oral cancers may
present special opportunities for evaluating economic impacts of emerging
changes in specific health care practices. Increasingly, sophisticated
simulations models are being developed which are designed to evaluate the
cost-effectiveness of cancer prevention, screening and treatment
interventions.  These models require more extensive and more detailed cancer-
related economic data than has generally been available in the past.

Scope of Activity

This initiative supports research directed at increasing our understanding of
economic aspects of cancer prevention, screening and care.  Cancer is a
heterogeneous chronic disease characterized by innovation in treatment and
care approaches.  Studies that cover the national population of all ages on an
episodic basis fail to capture an adequate sample of cancer patients or the
full scope and duration of cancer costs.  Studies that focus on a convenience
sample of cancer patients in a single health care delivery setting or
community can be criticized as lacking external validity.  Studies proposed in
response to this PA will be expected to address these issues and propose
innovative methods of overcoming these limitations.  Three broad topics are
included in this PA:

1.  The cost of cancer treatment and care in various organizational settings.

2.  Collection of economic data in the context of clinical trials and the use
of economic data and analysis in the design of trials.

3.  Cost-effectiveness of cancer prevention and screening trials and cancer
prevention and control interventions.

Priority Program Areas

The purpose of this PA is to solicit collaborative research between academics
in the fields of health economics and health services research and clinical
researchers in cancer.

The specific research goals of this PA are:

1.  The cost of cancer treatment and care related to specific cancer control
programs and strategies as implemented in various health care delivery
organizational settings.

To develop and validate methods for collecting reliable and representative
data on longitudinal patterns of health care resource use, expenditures and
costs for cancer prevention, screening, diagnostic, treatment, and care in
various organizational settings.

To develop and validate methods for collecting reliable and representative
data on the cost of continuing care for cancer patients.  These costs include
not only out-of-pocket costs for medical treatment and other health care-
related expenses, such as costs associated with preventing or treating oral
complications of cancer therapies, such as the rampant caries or mucosal
lesions which can be associated with head/neck radiation or some
chemotherapeutic regimens, but also other monetary and non-monetary disease
and treatment costs to the cancer patient and the family of the cancer
patient.

To explore alternative proposed and existing models of out-patient and
home-based continuing care for cancer patients in order to determine efficient
modes of organization that provide access to and meet the continuing care
needs of cancer patients and their families.

2.  Collection of economic data in the context of clinical trials and the use
of economic data and analysis in the design of trials.

To determine the cost of the health care intervention (e.g., cancer
prevention, control, treatment or rehabilitation) in NCI, NIDR or AHCPR-
sponsored trial settings compared to standard cancer control and treatment
settings.

To critically examine available statistical and modeling methodologies, or
develop new methodologies, for ascertaining estimates of direct and indirect
lifetime costs, based on data collected from clinical trials.

3.  Cost-effectiveness of cancer prevention and screening trials and cancer
prevention and control interventions .

To review and evaluate the existing conceptual basis, methodology and
application of cost effectiveness analysis to cancer related interventions. 
Studies should identify conceptual, methodological and data collection
problems unique to cancer related interventions and propose solutions to these
problems.  Studies should also include an evaluation of the appropriate role
of cost effectiveness analysis in policy formulation related to cancer and how
this role relates, or should relate, to medical ethics, equity and fairness,
and community values.

To determine the cost effectiveness of NCI, NIDR or AHCPR-sponsored cancer
prevention and screening trials.  Studies should include an analysis of the
important determinates of cost effectiveness, the level of uncertainty of
these determinates, and how these determinates might be affected by
alternative trial designs.

To determine the cost effectiveness of cancer prevention and control
interventions as implemented through the health care system.  Studies should
include an analysis of the important determinates of cost effectiveness, the
level of uncertainty of these determinates, and how these determinates might
be affected by alternative health care delivery settings and health care
policies.  The relevance of cost effectiveness analysis for the particular
question studied should be demonstrated by showing that it contributes
additional information to the health care decision making process than would
be available from clinical trial efficacy information alone.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH and AHCPR 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 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 20, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.  AHCPR follows these guidelines as applicable.

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.

POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH
INVOLVING HUMAN SUBJECTS

It is the policy of NIH and AHCPR that children (i.e., individuals under the
age of 21) must be included in all human subjects research, conducted or
supported by the NIH, unless there are clear and compelling scientific and
ethical reasons not to include them. This policy applies to all initial (Type
1) applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://www.nih.gov/grants/guide/notice-files/not98-024.html

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95) and will be accepted at the standard application deadlines as indicated
in the application kit.  Application 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 301/435-
0714, Email: grantsinfo@nih.gov.  Application kits are also available at
http://www.nih.gov/grants/forms.htm

The title and number of the program announcement must be typed in Section 2 on
the face page of the application.

An applicant planning to submit an application requesting $500,000 or more in
direct costs for any year is advised that he or she must contact Institute or
Center program staff listed in the INQUIRES section of this PA before
submitting the application.  See NIH policy at
http://www.nih.gov/grants/guide/notice-files/not98-030.html.

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

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established Public Health
Service referral guidelines. Applications will be reviewed for scientific and
technical merit in accordance with the standard NIH and AHCPR peer review
procedures.  Following scientific-technical review, the applications may
receive a second-level review by the appropriate national advisory council.

Review Criteria

The goals of the supported research are to advance our understanding of
biological systems, improve the control of disease, improved health care
services and enhance health.  The reviewers will comment on the following
aspects of the application in their written critiques in order to judge the
likelihood that the proposed research will have a substantial impact on the
pursuit of these goals.  Each of these criteria will be addressed and
considered by the reviewers in assigning the overall score weighting them as
appropriate for each application.  Note that the application does not need to
be strong in all categories to be judged likely to have a major scientific
impact and thus deserve a high priority score.  For example, an investigator
may propose to carry out important work that by its nature is not innovative
but is essential to move a field forward.

1.  Significance.  Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced? 
What will be the effect of these studies on the concepts or methods that drive
this field?

2.  Approach.  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

3.  Innovation.  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?

4.  Investigator.  Is the investigator appropriately trained and well suited
to carry out this work?  Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?

5.  Environment.  Does the scientific environment in which the work will be
done contribute to the probability of success?  Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional support?

The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific goals of the
research and plans for the recruitment and retention of subjects; the adequacy
of plans for including children as appropriate for the scientific goals of the
research, or justification for exclusion; the provisions for the protection of
human and animal subjects; and the safety of the research environment.

AWARD CRITERIA

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, and program priority.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Martin Brown, Ph.D.
Applied Research Branch
National Cancer Institute
Executive Plaza North, Room 313
Bethesda, MD  20892-7344
Telephone:  (301) 496-5716
FAX:  (301) 435-3710
Email:  mb53o@nih.gov

Yen-pin Chiang, Ph.D.
Center for Outcomes and Effectiveness Research
Agency for Health Care Policy and Research
6010 Executive Boulevard, Suite 300
Rockville, MD  20852
Telephone:  (301) 594-4035
FAX:  (301) 594-3211
Email:  ychiang@ahcpr.gov

Patricia S. Bryant, Ph. D.
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-24E, MSC 6402
Bethesda, MD  20892-6402
Telephone:  (301) 594-2095
FAX:  (301-480-8318
Email:  pb36q@nih.gov

Direct inquiries regarding fiscal matters to:

Bill Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800 Ext. 250
FAX:  (301) 496-8601
Email:  ww14j@nih.gov

Mable Lam
Grant Management Staff
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852
Telephone:  (301) 594-1844
FAX:  (301) 594-3210
Email:  mlam@ahcpr.gov

Martin R. Rubinstein
Grants Management Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN44A, MSC 6402
Bethesda MD  20892-6402
Telephone:  (301) 594-4800
FAX:  (301)480-8301
Email:  mr49c@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.399, 93.121, and 93.226.  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 Title IX (42 USC 299-299C-6). Awards are
administered under PHS grants policies and Federal Regulations 42 CFR 52 and
67, Subpart A, and 45 CFR Part 74 and 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 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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