ECONOMIC STUDIES IN CANCER PREVENTION, SCREENING AND CARE

NIH GUIDE, Volume 22, Number 40, November 5, 1993



PA NUMBER:  PA-94-011



P.T. 34



Keywords:

  Health Care Economics 

  Cancer/Carcinogenesis 

  Disease Prevention+ 

  Health Services Delivery 



National Cancer Institute

Agency for Health Care Policy and Research



PURPOSE



The Division of Cancer Prevention and Control (DCPC), National Cancer

Institute (NCI) and the Agency for Health Care Policy and Research

(AHCPR) 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.  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.



The focus of this Program Announcement (PA) relates to the general

health services and medical treatment effectiveness research

supported by the AHCPR for a wide range of clinical conditions,

including cancer.  For example, AHCPR is presently supporting, and

continues to be interested in, research on the analysis of health

care costs, the measurement of patient outcomes, the cost

effectiveness of health care services and procedures, and the

development of methods used in studies of the quality and outcomes of

care.  Related research priorities for AHCPR are described in:

PA-93-045 "Cost and Financing Issues in Health Care Reform",

PA-93-063 "Primary Care and Health Care Reform", and RFA HS-94-002

"Medical Treatment Effectiveness Research."



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 Program

Announcement, Economic Studies in Cancer Prevention, Screening, and

Care, 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 and foreign, for-profit and

non-profit, public and private organizations, such as universities,

colleges, hospitals, laboratories, units of state or local

governments, and eligible agencies of the Federal government.

Applications from minority and women investigators are encouraged.



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 the planning, direction, and execution of the

proposed project.  Except as otherwise stated in this PA, 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.



Because the nature and scope of research proposed in response to this

PA may vary, it is anticipated that the size of award will vary also.

The anticipated amount of the direct costs per award will vary from

$50,000 to $500,000 per year.  Expenses incurred in development and

implementation of the proposed research, including baseline and

follow-up surveys, design of materials, and professional education

are allowable costs.



RESEARCH OBJECTIVES



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:



o  The cost of cancer treatment and care in various organizational

settings.



o  Collection of economic data in the context of clinical trials and

the use of economic data and analysis in the design of trials.



o  Cost-effectiveness of cancer prevention and screening trials and

cancer prevention and control interventions.



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 in various 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 related expenses 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 sponsored

trial settings compared to standard cancer control and treatment

settings.



To determine the feasibility of collecting data on direct and

indirect lifetime costs in the context of clinical trials.



To collect data on direct and/or indirect lifetime cost in the

context of a clinical trial.



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 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 effected 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 effected 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.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements are required to include minorities and women

in study populations so that research findings can be of benefit to

all persons at risk of the disease, disorder or condition under

study; special emphasis must placed on the need for inclusion of

minorities and women in studies of diseases, disorders and conditions

which disproportionately affect them.  This policy is intended to

apply to males and females of all ages.  If women or minorities are

excluded or inadequately represented in clinical research,

particularly in proposed population-based studies, a clear and

compelling rationale must be provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues must be addressed in developing a research

design and sample size appropriate for the scientific objectives of

the study.  This information must be included in the form PHS 398

(revised 9/91) in Sections 1-4 of the Research Plan AND summarized in

Section 5, Human Subjects.



Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However,

the NIH recognizes that it may not be feasible or appropriate in all

research projects to include representation of the full array of

United States racial/ethnic minority populations [i.e., Native

Americans (including American Indians or Alaskan Natives),

Asian/Pacific Islanders, Blacks, Hispanics].  The rationale for

studies on single minority population groups should be provided.



For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of etiology, epidemiology,

prevention (and preventive strategies), diagnosis, or treatment of

diseases, disorders or conditions, including but not limited to

clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



If the required information is not contained within the application,

the application will be returned.



Peer reviewers will address specifically whether the Research Plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the

selected study population is inadequate, it will be considered a

scientific weakness or deficiency in the study design and will be

reflected in assigning the priority score to the application.



All applications for clinical research submitted to the NIH are

required to address these policies.  NIH funding components will not

award grants or cooperative agreements that do not comply with these

policies.



In cases where the proposed study involves collaboration with an

ongoing NCI sponsored trial the application must include a letter

from the principal investigators of that trial indicating the

latter's endorsement of the proposed study and willingness to

collaborate.  Any grant proposing association with an existing NCI

trial would, of course, have to be approved by NCI grants or

contracts administration and by the project officer to the existing

trial before submission.  All regulations involving human subjects

and release of data applicable to the original trial would apply to

the supplemental grant.



APPLICATION PROCEDURES



The research grant application form PHS 398 (rev. 9/91) is to be used

in applying for these grants.  The application package is available

at most institutional offices of sponsored research and from the

Office of Grants Information, Division of Research Grants, National

Institutes of Health, Westwood Building, Room 449, Bethesda, MD

20892, telephone 301-435-0714.  The title and number of the

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:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



Applications will be assigned to the appropriate PHS study section,

by the Division of Research Grants on the basis of established Public

Health Service referral guidelines. Applications will be reviewed by

the study section for scientific and technical merit in accordance

with standard PHS peer review procedures.  The following criteria

will be considered when assessing the merit of a research grant

application:



o  scientific, technical or clinical 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 for the research;



o  appropriateness of the proposed budget and timetable in relation

to the scope of the proposed research;



o  adequacy of the proposed means for protecting against or

minimizing potential adverse effects upon humans, vertebrate animals,

and/or the environment; and



o  for studies involving minorities and both genders subjects in

research, the adequacy of plans to include minorities and both

genders in the study design, and the potential of that design to

address the scientific question(s) addressed.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications assigned to that ICD.  The following will be considered

in making funding decisions:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement



INQUIRIES



Written and telephone inquiries concerning the objectives and scope

of this PA, or 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.



Martin L. Brown

Division of Cancer Prevention and Control

National Cancer Institute

Executive Plaza North, Suite 300

Bethesda, MD  20892

Telephone:  (301) 496-8500

FAX:  (301) 496-8667



Michael Hagen

Program Officer

Agency for Health Care Policy and Research

2101 East Jefferson Street, Suite 502

Rockville, MD  20852-4908

Telephone:  301/594-1354



Direct inquiries regarding budgetary, administrative, and/or policy

issues to:



Mrs. Eileen M. Natoli

Grants Administration Branch

National Cancer Institute

Executive Plaza South, Suite 242

Bethesda, MD  20892

Telephone:  (301) 496-7800

FAX:  (301) 496-8601



Ralph Sloat, Grants Management Officer

Agency for Health Care Policy and Research

2101 East Jefferson Street, Suite 601

Rockville, MD  20852

Telephone:  (301) 594-1447



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance No. 93.399, Cancer Control Research.  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 grants policies and Federal

Regulations 42 CFR 52 and 45 CFR Part 74 and 92.  This program is not

subject to the intergovernmental review requirements of Executive

Order 12372 or Health Systems Agency review.



.


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