CLINICAL CANCER THERAPY RESEARCH

NIH GUIDE, Volume 21, Number 15, April 17, 1992



PA NUMBER:  PA-92-69



P.T. 34



Keywords:

  Cancer/Carcinogenesis 

  Clinical Medicine, General 

  Chemotherapy 

  Treatment, Medical+ 

  Drug Metabolism 

  Pharmacology 



National Cancer Institute



PURPOSE



The National Cancer Institute (NCI) seeks grant applications to conduct

clinical therapeutic studies of neoplastic diseases in humans.

Clinical research, by definition, involves a clinician/patient-subject

interaction with a therapeutic intent.  This Program Announcement (PA)

encompasses a full range of therapeutic studies and clinical trials

employing drugs, biologics, radiation, and surgery.  The intent of the

announcement is to encourage clinical researchers to translate insights

in cancer biology and the development of new agents into innovative

cancer therapeutic 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 PA,

Clinical Cancer Therapy Research, 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 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.  Foreign institutions

are not eligible for the First Independent Research Support and

Transition (FIRST) Award (R29).  Applications from minority individuals

and women are encouraged.  An application may include one or more

institutions (e.g., individual institutions, consortia, cancer centers)

with established clinical, laboratory, and statistical resources.



MECHANISM OF SUPPORT



Awards will be made as investigator-initiated research grants (R29, R01

and interactive R01s) through the National Institutes of Health (NIH)

grant-in-aid, in accordance with PHS policies applicable to research

project grants. This latter mechanism is used when the NCI wishes to

stimulate investigator-initiated research projects in areas of special

interest to the National Cancer Program.  A description of an

interactive R01 application can be found in the NIH Guide for Grants

and Contracts (Vol. 21, No. 1, January 10, 1992) under PA-92-29.  The

special eligibility criteria for the FIRST Award (R29) can be found in

the Guidelines for FIRST AWARD (version February 1991), which may be

obtained from the Grants Inquiries Office, Division of Research Grants,

NIH.  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 Public Health

Service Grants Policy Statement, DHHS Publication No. (OASH) 82-50,000,

revised January 1, 1987.



RESEARCH OBJECTIVES



Summary



In the past several years, the research effort into understanding the

basic biology of the cancer cell has been highly productive. Recent

discoveries concerning the role of growth factors, genes that promote

and suppress neoplasia, mechanisms of treatment sensitivity and

resistance, and the biology of the immune systems have provided the

basis for the development of novel and improved cancer treatments.  The

rate of progress in the treatment of cancer will depend upon the

translation of these basic and preclinical discoveries into clinical

cancer therapies. The NCI supports an extensive network of clinical and

laboratory research studies related to cancer therapy through

contracts, grants, and cooperative agreements.  At present, the

traditional research grant mechanism (R01, R29) is underutilized by

clinical investigators for the support of clinical research.  The

Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment,

NCI, the program primarily responsible for the promotion and

translation of new basic and preclinical research into therapeutic

advances, receives relatively few research grant applications.  Whereas

a Request for Applications (RFA) represents a single solicitation, a PA

provides the opportunity for the receipt of new applications on a

continuing basis.  NCI encourages clinical investigators to submit

clinical therapeutic studies and is committed to moving advances in

basic biology and drug development into the clinical setting.



Clinical studies must involve human subjects and be designed to

ultimately improve cancer treatment.  The applications may include

single or multi-institutional research studies with appropriate

biological correlates linked to these studies.  New clinical

therapeutic studies may employ drugs, biologics, radiation, or surgery

used as single agents/modalities or in combination.  Biological

correlative studies that have clinical relevance to cancer therapies

and are aimed at improving cancer treatment are also appropriate.



Some examples of clinical therapeutic studies include:  (1) therapies

based on novel mechanisms of action, mechanism of action and metabolic

studies of antitumor agents; (2) studies of mechanisms of hormone-,

drug-, or radiation-resistance and reversal; (3) mechanism of action of

biological response modifiers in the treatment of cancer, e.g., cancer

immunotherapy (monoclonal antibodies, cytokines, antisense, and

vaccines) alone or in combination with chemotherapeutic agents; (4)

mechanism of action of new growth factor targeted therapies; (5) new

radiation therapies or radiation modifiers to enhance cell kill or

protect normal tissue; (6) surgical therapies in combination with

therapeutic agents.



Some examples of biological correlative studies include:  (1)

phenotypic or genotypic alterations that appear to correlate with the

development of drug-, hormone-, or radiation-resistance; (2) oncogenes,

growth factors, and specific antigen expression on tumor cells; (3)

pharmacokinetic and pharmacodynamic measurements; (4) biochemical

pharmacologic parameters; (5) imaging studies to assess efficacy of

treatment.



Investigators are not limited to the above areas of potential studies.

Clinical research, by definition, must involve a

clinician/patient-subject interaction with a therapeutic intent.



Objectives



The aims of this initiative are two-fold:  (1) to support innovative

correlative laboratory studies relevant to therapeutic clinical trials

and  (2) to stimulate development of innovative therapeutic clinical

studies with laboratory correlations to foster the development of

interactions between basic science laboratories and clinicians

performing these clinical trials.



STUDY POPULATION



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF FEMALES AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical

research grants and cooperative agreements will be 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 should be 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

compelling rationale should 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 should be addressed in developing a research

design and sample size appropriate for the scientific objectives of the

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

Section 2, 1-4 of the Research Plan AND summarized in Section 2, E,

Human Subjects.  Applicants are urged to assess carefully the

feasibility of including the broadest possible representation of

minority groups.  However, 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 deferred until the information is provided.



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 NIH are required to

address these policies.  NIH funding components will not award grants

or cooperative agreements that do not comply with these policies.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS 398

(rev. 9/91) and will be accepted at the deadlines indicated in the

application kit (February 1, June 1, and October 1).  Specific

application procedures for interactive R01 applications can be found in

the NIH Guide for Grants and Contracts (Vol. 21, No. 1 - January 10,

1992) under PA-92-29.



Application kits are available at most institutional business offices

and may be obtained from the Office of Grants Inquiries, Division of

Research Grants, National Institutes of Health, Westwood Building, Room

449, Bethesda, MD 20892, telephone 301/496-7441.  The title and number

of the announcement must be typed in Section 2a on the face page of the

application.



Applicants from institutions that have a General Clinical Research

Center (GCRC) funded by the NIH National Center for Research Resources

are requested to identify the GCRC as a source for conducting the

proposed research. In such a case, a letter of agreement from either

the GCRC program director or Principal Investigator must be included

with 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 PROCEDURES



Applications will be assigned on the basis of established Public Health

Service referral guidelines.  Applications will be reviewed for

scientific and technical merit by study sections of the Division of

Research Grants, NIH, in accordance with the standard NIH peer review

procedures.  Following scientific-technical review, the applications

recommended for further consideration will receive a second-level

review by the appropriate national advisory council.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications.  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 are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Dr. Roy S. Wu or Ms. Diane Bronzert

NCI Program Directors

Cancer Therapy Evaluation Program

Division of Cancer Treatment

National Cancer Institute

Executive Plaza North, Room 734

Bethesda, MD  20892

Telephone:  (301) 496-8866

FAX:  (301) 480-4663



Direct inquiries regarding fiscal matters to:



Ms. Marian Focke

Grants Management Specialist

National Cancer Institute

Executive Plaza South, Room 242

Bethesda, MD  20892

Telephone:  (301) 496-7800, ext. 46

FAX:  (301) 496-8601



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No 93.395, Cancer Treatment 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

at 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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