Economic Studies in Cancer Prevention, Screening, and Care

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Note: This announcement has been superceded and is maintained for archival purposes only. Select for the current Studies of the Economics of Cancer Prevention, Screening, and Care announcement.

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NIH Guide for Grants and Contracts, November 12, 1998
Ongoing Program Announcement

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

PA: PA-99-014

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Note: This program announcement was published in the NIH Guide for Grants and Contracts on November 12, 1998. It replaces PA-94-011, which was originally published in the NIH Guide for Grants and Contracts, Vol. 22, No. 40, on November 5, 1993.

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Purpose

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.

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 print 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 nonprofit 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 interventions 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 (http://www.nap.edu/catalog.php?record_id=6225) 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 HHS panel on cost effectiveness in health and medicine (as summarized in Gold M.R., 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 Food and Drug Administration (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 simulation models are being developed that 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.
   1. 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.
   2. 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 (e.g., costs associated with preventing or treating oral complications of cancer therapies, such as the rampant caries or mucosal lesions that can be associated with head/neck radiation or some chemotherapeutic regimens), but also other monetary and nonmonetary disease and treatment costs to the cancer patient and the family of the cancer patient.
   3. (c) 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.
   1. 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.
   2. 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.
   1. 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, fairness, and community values.
   2. 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.
   3. 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 decisionmaking 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 on March 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, on 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, on March 6, 1998, and is available at the following URL: 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 20857-7910
Telephone: (301) 435-0714
E-mail: grantsinfo@nih.gov

Application kits are also available at: http://grants.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 "Inquiries" section of this PA before submitting the application. See the 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 20857-7710
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 biologic 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 20857-7344
Telephone: (301) 496-5716
Fax: (301) 435-3710
E-mail: mb53o@nih.gov

Yen-pin Chiang, Ph.D.
Center for Outcomes and Effectiveness
Agency for Healthcare Research and Quality
540 Gaither Road, Suite 6000
Rockville, MD 20850
Telephone: (301) 427-1493
E-mail: YChiang@ahrq.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 20857-6402
Telephone: (301) 594-2095
Fax: (301) 480-8318
E-mail: pb36q@nih.gov

Direct inquiries regarding fiscal matters to:

Bill Wells
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD 20857
Telephone: (301) 496-7800, ext. 250
Fax: (301) 496-8601
E-mail: ww14j@nih.gov

Mable L. Lam
Grants Management Staff
Agency for Healthcare Research and Quality
540 Gaither Road, Suite 4000
Rockville, MD 20850
Telephone: (301) 427-1448
E-mail: MLam@ahrq.gov

Martin R. Rubinstein
Grants Management Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN44A, MSC 6402
Bethesda MD 20857-6402
Telephone: (301) 594-4800
Fax: (301) 480-8301
E-mail: 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 nonuse 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.

Current as of November 12, 1998
AHCPR Publication No. 99-R009