From: kristoff@GENBANK.BIO.NET (Dave Kristofferson)
Newsgroups: bionet.sci-resources
Subject: NIH Guide, vol. 21, no. 30, pt. 4, 21 August 1992
Date: 21 Aug 92 19:21:18 GMT
Distribution: bionet


$$XID RFA PA92101 PA-92-101 P2O2 ***************************************
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Appendix I

INTRODUCTION

This appendix lists data sources which may be useful to applicants in
designing a study under this announcement.

The Alcohol Epidemiologic Data System (AEDS) prepares periodic reports
in four major areas:

o  Liver Cirrhosis Mortality

o  Trends in Alcohol-Related Fatal Traffic Accidents

o  Apparent Per Capita Alcohol Consumption

o  Alcohol-Related Hospital Discharges

In the first three areas, data are available at the State level.  In
addition, alcohol-related data are available in a "Data Reference
Manual" series.  The publications in this series cover cirrhosis
mortality, hospital discharges, and per capita consumption, plus a
volume entitled "County Alcohol Problem Indicators, 1979-1985."  It
provides data on alcohol-related mortality for counties, States, and
the United States.  AEDS also produces a "Data Catalog" that summarizes
the contents of many national-level data sets useful for alcohol
research.  The catalog and most of these reports are available by
writing AEDS, c/o Cygnus Corporation, Suite 1275, 1400 Eye Street, NW,
Washington, DC 20005.

The U.S. Government's health survey organization, the National Center
for Health Statistics (NCHS), in April 1985, published a valuable
analysis of its data resources related to research on alcohol, drug
abuse, and mental health problems.  Entitled "An Inventory of Alcohol,
Drug and Mental Health Data Available from the National Center for
Health Statistics," it can be obtained from the National Technical
Information Service, document PB 85-226199, or is available in
libraries that carry the NCHS Statistical Report Series.  It is filed
under the subtitle "Programs and Collection Procedures, Series 1, No.
17."

Detailed data on fatal traffic accidents are available from the
National Highway Traffic Safety Administration's (NHTSA) Fatal Accident
Reporting System.  Published reports can be requested from the National
Center for Statistics and Analysis, NHTSA, NRD 30, 400 7th Street, SW,
Washington, DC 20590.  Data tapes are available from DOT Transportation
Systems Center, Attention: John F. Mitchell, DTS 32, Kendall Square,
Cambridge, MA  02442.

Alcoholism treatment data have been collected in census surveys of the
treatment system in the National Drug and Alcoholism Treatment Unit
Surveys conducted in 1979, 1980, 1982, 1987, 1989, and 1990.  Recent
summary reports and access to data tapes are available through the
Alcohol Epidemiologic Data System (AEDS), mentioned earlier.

DESCRIPTION OF MAJOR DATA SETS TO SUPPORT EPIDEMIOLOGICAL RESEARCH

Through AEDS, the Division of Biometry and Epidemiology (DBE) has
acquired several hundred data sets over the past nine years.

Many of these data sets are from small regional or local surveys with
limited potential for analysis at the national level.

There are, however, a number of national-level data sets that routinely
form the core of AEDS' secondary data analysis efforts.  These data
sets are national surveys of alcohol consumption and abuse, and
national mortality and morbidity statistics.  They include the:

o  National Health and Nutrition Examination Survey I
o  National Health and Nutrition Examination Survey II
o  National Health and Nutrition Examination Survey I, Epidemiologic
Follow-up Study
o  Hispanic Health and Nutrition Examination Survey
o  National Health Interview Survey 1983
o  National Health Interview Survey 1985
o  National Health Interview Survey 1987
o  National Health Interview Survey 1988
o  National Natality Survey and National Fetal Mortality Survey 1980
o  National Maternal and Infant Health Survey 1988
o  Multiple Cause of Death, Mortality Detail 1968-1988
o  National Mortality Followback Survey 1986
o  National Hospital Discharge Survey 1975-1989
o  Fatal Accident Reporting System 1975-1989
o  (MEDSTAT)

With the exception of the Fatal Accident Reporting System (operated by
the National Highway Traffic Safety Administration) and the MEDSTAT
data sets (provided by MEDSTAT Systems, Inc.), all of these data sets
are operated by the National Center for Health Statistics (often with
funding and planning assistance from NIAAA).

This section presents a brief narrative description of each data set.
Each description discusses the data set's sample, key variables (e.g.,
demographic variables) and alcohol related variables.

National Health and Nutrition Examination Survey I (NHANES I)

The NHANES I is a nationwide, multistage, stratified probability sample
of about 24,000 persons 1-74 years old.  Data are weighted to represent
the civilian, non institutionalized population of the 48 contiguous
States, excluding Indian reservations.

Data were collected between April 1971 and October 1975 on the medical
history, examination, diet, and laboratory tests of sample persons.
Demographic data on age, sex, race, ethnicity, education, occupation,
employment status, marital status, income, and language were also
collected.

The medical exam portion of NHANES I has four questions related to
alcohol:

o  During the last year, have you had at least one drink of beer, wine
or liquor?

o  How often do you drink?  (Range goes from daily to 2 or 3 times per
year, for those who answered "yes" to question 1 above.)

o  Which do you most frequently drink (beer, wine, liquor)?

o  When you do drink (beer/wine/liquor), how much do you usually drink
over 24 hours?

The 24-hour dietary recall interview codes are for alcohol ingested
during a 24-hour period.  Also, information on caloric value for each
food substance ingested has been included to permit analysis of food
calories, alcohol calories, and percentage of alcohol in the diet.

While the battery of NHANES I interviews, exams, and tests were
administered to persons 1-74 years old, the alcohol consumption data
were collected from persons 12-74 years old.

Previous researchers suggest merging data from the medical exam and
24-hour dietary recall interview to analyze alcohol consumption.  Given
the extensive medical and nutritional data provided in NHANES I, this
data base appears to be useful in associating alcohol consumption with
other nutritional indices and medical characteristics.

National Health and Nutrition Examination Survey II (NHANES II)

The NHANES II is a stratified, multistage, probability sample of the
civilian noninstitutionalized U.S. population.  Approximately 21,000
people between the ages of 6 months and 74 years were interviewed
between 1976 and 1980.

As part of the NHANES series, this survey is designed to monitor the
nutritional status and medical condition of the U.S. population.  Eight
separate survey instruments are used to collect data on medical
history, diet, medication and vitamin usage, and behavior.  Three
subgroups of the population are given special consideration in the area
of nutritional assessment.  These are:  preschool children (6 months -
5 years), the aged (60-74 years), and persons whose income was below
the 1970 poverty level.

Frequency of alcohol consumption and beverage preference are obtained
from the Dietary 24-hour Recall and Dietary Frequency form.  Only
respondents aged 12-74 are asked for this information.

National Health and Nutrition Epidemiologic Follow-up Survey (NHEFS)

Although NHANES I provided a wealth of information on the prevalence of
health conditions and risk factors, the cross sectional nature of the
original survey limits its usefulness for studying the effects of
clinical, environmental, and behavioral factors and in tracing the
natural history of disease.  Therefore, the NHEFS was designed to
investigate the association between factors measured at baseline and
the development of specific health conditions.  This is an important
consideration in determining the long term health effects of behaviors
such as alcohol and tobacco use.

Three waves of the NHEFS have been completed to date:

In the first wave, conducted from 1982-84, data were collected on all
14,407 subjects that were examined at NHANES I.  Detailed data from
personal interviews on health, nutrition, exercise and other behaviors
were collected in addition to standard demographic variables.

The second wave, completed in 1986, collected information by telephone
interviews on changes in the health and functional status since the
last contact with the older members of the NHEFS cohort.  It was
restricted to those subjects who were at least 55 years old at NHANES
I.

Finally, the third wave of the NHEFS was a follow-up of the entire
cohort similar to the 1982-84 survey.  Data on changes in health status
and behavior were obtained primarily through telephone interviews.

Alcohol questions were included in each wave of the follow-up and
covered the following broad topic areas:

o  reasons for not drinking;
o  quantity and frequency of consumption; and
o  lifetime drinking patterns.

All three waves of the NHEFS can be linked to the baseline survey using
individual patient identifying numbers.

Hispanic Health and Nutrition Examination Survey (HHANES)

The HHANES is the first survey in the HANES series targeted
specifically at a U.S. minority.  Data were collected on approximately
12,000 Mexican-Americans, Cuban-Americans and Puerto Ricans between
1982 and 1984.  As part of the HANES series, the purpose of the survey
is to monitor the health and nutritional status of the U.S. Hispanic
population.

The core instrument collects detailed information on medical history,
health problems, nutritional status, and laboratory tests, in addition
to standard demographics.  The Alcohol, Drug Abuse, and Mental Health
Administration sponsored the supplement, which was administered during
the medical exam to persons 12 to 74 years of age.

The alcohol section is composed of 75 questions designed to elicit
information on the quantity, frequency, and volume of consumption,
lifetime drinking patterns, self-classification of drinking type, and
reasons for not drinking currently.  The survey is designed so that
alcohol consumption can be correlated with the health and nutrition
parameters identified by the core instrument.

National Health Interview Survey (NHIS 83) Alcohol/Health Practices
Questionnaire

This survey is designed to collect information on health status, health
habits, disabilities, and contacts with health practitioners.
Conducted over several years, the NHIS data provide the largest source
of linked records relating general health status of the U.S. population
with measures of alcohol consumption.

Data were collected in 1983 on approximately 25,000 people age 18 and
above.  The core instrument contains questions eliciting information on
health and behavior practices, doctor services, and dental care.

The alcohol supplement is essentially identical to the HHANES
supplement.  The main differences are that NHIS 83 employs a 2-week
reference period for alcohol consumption questions as opposed to
HHANES' 4-week period; and NHIS 83 includes a series of questions
covering specific alcohol-related problems.

National Health Interview Survey (NHIS 85) Health Promotion and Disease
Prevention Questionnaire

The NHIS 85 continues the focus of previous waves of the NHIS by
collecting data on the health and health care visits of Americans.
Approximately 33,000 people age 18 and older were interviewed in 1985.

As in 1983, alcohol questions are included in a separate questionnaire.
The 1985 alcohol questions are not as detailed as those for 1983.
However, information on lifetime drinking, quantity and frequency of
consumption, reasons for not drinking, and alcohol-related problems is
collected.  For the first time, questions on the public's awareness of
fetal alcohol syndrome are asked on a NHIS instrument.

National Health Interview Survey (NHIS 87) Epidemiology Study

This survey includes basic information (e.g., health status, health
habits, physician visits, and a wealth of demographic information) from
the core questionnaire of the NHIS and various cancer risk factors
(including alcohol) in the Epidemiology Study.

The NHIS 87 Epidemiology study includes questions on acculturation,
food frequency consumption items (over 60 food categories, including
alcohol) smoking habits, other tobacco use, reproduction and hormone
use, family history of cancer, cancer survivorship, occupational
exposures, and relationships and social activities.

Data were collected on 22,080 respondents aged 18 years and older, with
an oversample conducted in Hispanic households.

As part of the section on food frequencies, the alcohol questions in
the NHIS 87 include separate quantity-frequency items on beer, wine,
and liquor.  The beverage-specific items ask the number of times in the
past year each beverage was consumed, the number of drinks consumed
when the respondent drank, and the portion size (small, medium, or
large) of the drink(s).  A final two questions on alcohol ask:  (1) if
there was any period in which the respondent drank 5 or more drinks of
alcoholic beverage almost every day, and (2) how long the period
lasted.

National Health Interview Survey (NHIS 88) Alcohol Section

Portions of this survey replicate the alcohol questionnaire in the NHIS
83, but the survey is expanded considerably to include questions on the
drinking level of each family member, family history of alcoholism or
problem drinking, and symptoms of alcohol abuse and alcohol dependency.

A randomly selected person 18 years of age or older from each household
in the NHIS sample was asked to respond to the alcohol section.  The
completed number of questionnaires for the alcohol section was 43,809,
a response rate of about 87 percent.

As with the NHIS 83, the alcohol questions in the NHIS 88 are very
detailed, with specific quantity-frequency items on beer, wine and
liquor, along with estimates of total alcohol intake.  Other drinking
behaviors also are examined in detail, including drinking history as
represented by any periods of light, moderate, and heavier drinking
over the respondent's lifetime.  The lifetime and the past-year
prevalence of 41 symptoms of alcohol abuse and alcohol dependency are
asked of current drinkers; lifetime prevalence of these symptoms is
asked of former drinkers.  Also, overall consumption of alcohol in the
past year is asked of all respondents, except lifetime abstainers.
Detailed consumption items are asked of all current drinkers.

National Natality Survey and National Fetal Mortality Survey 1980
(NNS/NFMS 1980)

These two different surveys utilize the same survey instruments and are
designed to enable analyses of high-risk pregnancies.  Data were
collected in 1980 on:  (a) a sample of 9,941 live birth (or fetal
death) certificates; (b) a questionnaire mailed to married mothers; and
(c) questionnaires mailed to 3 types of medical service providers (as
appropriate) -- attendants at delivery, hospital, and radiologic
services.  Data from these surveys include numerous personal,
demographic, health status, health practices, health resources
utilization, and infant status variables.

The questionnaires mailed to the mother contained the following four
alcohol questions:

o  Did mother drink alcoholic beverages during 12 months before
delivery?
o  Frequency and amount of alcohol consumption before pregnancy?
o  Frequency and amount of alcohol consumption during pregnancy?
o  Kinds of alcoholic beverages consumed (in 7 categories of beer,
wine, liquor, and combinations).

National Maternal and Infant Health Survey (NMIHS) 1988

The 1988 NMIHS is a nationally representative followback survey of
mothers, their prenatal care providers, and their hospitals of delivery
conducted by the National Center for Health Statistics (NCHS).  The
main purpose of the survey is to study some of the factors related to
poor pregnancy outcomes such as maternal smoking, drinking, and drug
use.  It is also useful in assessing  progress towards achieving
maternal and infant health objectives set by the U.S. Department of
Health and Human Services for the year 2000.  The sample consisted of
11,000 women who had live births, 4,000 who had late fetal deaths, and
6,000 who had infant deaths.  Based on information from certificates of
live births, reports of fetal death, and certificates of infant death
in 1988, questionnaires were mailed to mothers irrespective of marital
status.  Prenatal care providers and hospitals of delivery were
contacted after being identified by the mother.  Then information
supplied by mothers, prenatal care providers, and hospitals of delivery
was linked with the vital records to expand knowledge of maternal and
infant health.  This survey includes data on demographic
characteristics, personal characteristics, health status, health
practices, health resources utilization, other pregnancies and
deliveries, and infant status.

The questionnaire mailed to the mother contained the following alcohol
questions:

o  Did mother drink any alcoholic beverages during the 12 months before
delivery?
o  Frequency and amount of alcohol consumption before pregnancy?
o  Frequency and amount of alcohol consumption during pregnancy?
o  Did mother reduce drinking of alcoholic beverages during pregnancy?
o  Reason for reducing drinking of alcoholic beverages during
pregnancy?

A Longitudinal Follow-up (LF) of mothers in the survey was planned to
provide information on health and development of low-birth weight
babies, child care and safety, maternal health, maternal depression,
and plans for adoption and foster care.  Data collection for the LF
survey started in January 1991.

Multiple Cause of Death, Mortality Detail, 1968-1988

These tapes contain vital statistics data for both underlying and
multiple causes of death for all deaths occurring during a particular
calendar year.  The tapes include deaths at any time after live birth;
therefore, no fetal deaths have been included.  Demographic variables
include date of death, age, race, sex, and geographic data.

There are specific disease categories under ICD-8 and ICD-9 which are
generally believed to be alcohol related (e.g., alcohol dependence
syndrome and cirrhosis of the liver).  These may be listed for specific
records, as underlying or contributing causes of death.

National Mortality Followback Survey, 1986 (NMFS)

The 1986 NMFS is designed to supplement information obtained from death
certificates with information on important characteristics of the
decedent that may have affected mortality.  These characteristics
include patterns of lifetime behavior, health services experience prior
to death, socioeconomic status, and many other aspects of life that may
affect when and how death occurs.  Data are based on a one percent
sample of deaths in 1986.  The tape consists of records for 18,733
decedents.  The records contain data from death certificates, the
informant survey questionnaire responses, and the facility abstract
record.  Starting with the death records as the sampling frame,
questionnaires were mailed to the next-of-kin addressing lifestyle and
health related variables.  Information from health care facilities in
which the decedent spent one or more nights during the last year of
life was obtained for 12,275 decedents.

Alcohol questions include:  whether the decedent ever had 12 drinks in
his/her lifetime, how often he/she had a drink, and on the days that
the decedent drank, how many drinks he/she had.  In addition to
diagnostic data on cause(s) of death and hospital diagnoses, the
informant was asked whether the decedent ever had cirrhosis of the
liver at any time in his/her life.

National Hospital Discharge Survey (NHDS) 1975-1989

The NHDS collects data from short-stay hospitals throughout the U.S.
excluding military, VA, and institutional hospitals.

Data are collected from the hospital record face sheets of a random
sample of discharges (sample size varies from year to year but is
generally around 220,000 discharges).  Basic demographic data (e.g.,
sex, age, marital status, and geographic location) are collected as
well as medical diagnoses and operations.

Data on four specific alcohol-related diseases, alcohol dependence,
alcohol abuse, alcoholic psychoses, and liver cirrhosis are recorded.
Other conditions with alcohol mentioned as a contributing factor also
can be analyzed.

Fatal Accident Reporting System (FARS) 1975-1990

The FARS is an automated system containing data on all fatal traffic
accidents occurring each year within the 50 States, the District of
Columbia, and Puerto Rico.  To be included, an accident must involve at
least one motor vehicle moving on a roadway customarily open to the
public, and result in the death of a person (occupant of a vehicle or
nonoccupant) within 30 days of the accident.  Data concerning fatal
traffic accidents are  gathered from the State's own source documents
and translated appropriately to codes on standard FARS forms.  The data
sources may include:  police accident reports; State vehicle
registration files; State driver licensing files; state highway
department files; vital statistics documents; death certificates;
coroner/medical examiner's reports; hospital medical reports; and
emergency medical services reports.

Some of the key variables recorded by FARS include age, sex, role in
the accident, injury severity, day of the week and time of day of the
accident, and the number of vehicles involved.

Alcohol involvement in an accident is determined with three variables.
They are:

o  a blood alcohol concentration (BAC) test;
o  the judgment of the investigating officer; and
o  whether DWI charges were filed (variable added in 1982).

MEDSTAT Systems Data Base 1987-1989

NIAAA has contracted with MEDSTAT Systems, Inc., of Ann Arbor,
Michigan, to provide a subset of the MEDSTAT data base, which consists
of more than 180 million health care claims for 5.7 million privately
insured individuals under the age of 65.  To produce the data base,
MEDSTAT contracts with more than 60 large U.S. corporations to collect
information on their employer-based health insurance programs.  Data
are collected from over 100 commercial insurance companies, Blue
Cross/Blue Shield plans, third party administrators, and
self-administered corporations.  (The data base is not a statistically
determined sample and it, therefore, is not nationally representative.)

The subset of the MEDSTAT data base acquired by NIAAA contains
approximately 2 million inpatient and outpatient claim records for
families in which at least one member had an alcohol- or other
drug-related condition or procedure.  Over 40 alcohol- and other
drug-related conditions and procedures are coded in the data base,
including alcoholic psychoses, alcohol dependence syndrome, alcohol
abuse, and liver cirrhosis (with and without mention of alcohol).  The
conditions are recorded on the claim forms with the International
Classification of Diseases, Ninth Edition, Clinical Modification
(ICD-9-CM) codes.  For billing and administrative purposes, the data
base also records conditions and procedures using the following three
coding systems: (1) Diagnosis Related Groups, (2) Current Procedural
Terminology, Fourth Edition, and (3) Health Care Procedure Codes.

In addition to the information on alcohol- and other drug related
conditions and procedures, the data base also contains variables
describing the demographic characteristics of the patients, benefits
plans, clinical treatment, and financial arrangements.

The initial version of the alcohol- and other drug-related conditions
and procedures data tape contains approximately 50,000  inpatient and
2 million outpatient claim records for the years 1987 through 1989.

LIMITATIONS OF MAJOR DATA SETS AVAILABLE TO SUPPORT EPIDEMIOLOGICAL
RESEARCH

It is generally accepted that alcohol contributes significantly to
overall morbidity and mortality.  What is unclear, however, is its
precise contribution to these events.  Recent estimates suggest that
alcohol may be involved in 15 to 90 percent of all serious events,
depending on the category of event (Roizen, 1982).  This is an
unacceptably broad range with little practical value for surveillance
efforts.

To arrive at more specific estimates of alcohol involvement in injury,
illness, and death, the Division of Biometry and Epidemiology regularly
undertakes analyses of a variety of data sets.  The most useful of
these are the several large national data sets described in the
previous section.

Analysis of these data sets enables NIAAA to estimate alcohol's
contribution to morbidity and mortality.  An example is:

o  There were 7.4 alcohol-related traffic deaths per 100,000 population
in 1989.

This discussion has not included all data sets that could potentially
be of use to researchers, but has focused on data sets that are
national in scope and contain alcohol-related data.  Other Federal
agencies as well as State agencies may have additional data resources
that would be of use to researchers.


$$XID RFA CA9225 CA-92-25 P1O1 *****************************************

INTERACTIVE R01S FOR CLINICAL STUDIES OF SYSTEMIC THERAPIES

NIH GUIDE, Volume 21, Number 30, August 21, 1992

RFA:  CA-92-25

P.T. 34; K.W. 0715035, 0785035, 0745070

National Cancer Institute

Letter of Intent Receipt Date:  October 22, 1992
Application Receipt Date:  December 22, 1992

PURPOSE

The Cancer Therapy Evaluation Program, Division of Cancer Treatment, at
the National Cancer Institute (NCI) invites Interactive Research
Project Grant (IRPG) applications (R01s) to perform research projects
designed to conduct clinical studies of innovative systemic therapies
investigating promising therapeutic approaches in a single tumor type
or focused on a single class of novel compounds or a mechanism of
action.

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 RFA,
Interactive R01s for Clinical Studies of Systemic Therapies, 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

Domestic and foreign for-profit and non-profit organizations,
governments and their agencies are eligible to apply.  Applications can
be from single institutions and multiple institutions (collaborating
institutions, consortia, cooperative groups).  New and experienced
investigators are encouraged to apply.  Applications from minority
individuals and women are encouraged.  Applicants proposing to perform
phase I clinical trials that address issues on the mechanisms of action
of immunologically active agents are not eligible for this RFA and
should apply for an RFA that will be issued by the Biological Response
Modifiers Program in the near future.

MECHANISM OF SUPPORT

Support of this program will be through the IRPG, an assistance
mechanism composed of three or more investigator-initiated research
grant applications (R01s) that will be reviewed for independent merit
but that share a theme and resource(s) and that require concurrent
funding to maximize the effectiveness of the resource or to allow
maximal creative interaction between researchers.  Except as otherwise
stated in this RFA, 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, revised October 1, 1990.

This RFA is a one-time solicitation for FY 93.  However, the NCI has
plans to re-issue this RFA for funding in 1994.  If it is determined
that there is a sufficient continuing program need, the NCI will invite
recipients of awards under this RFA to submit competitive continuation
applications for review according to the procedures described below.

FUNDS AVAILABLE

Approximately $4,000,000 in total costs per year for four years will be
committed to fund applications submitted in response to this RFA.  This
funding level is dependent on the receipt of a sufficient number of
applications of high scientific merit.  The total cost for each IRPG
(consisting of three or more R01s) is limited to $750,000 per year.
Thus it is anticipated that five to six IRPGs will be funded in FY 93.
In FY 93 it is anticipated that this RFA will be re-advertised and an
additional three IRPGs will be funded in FY 94.  The total project
period for applications submitted in response to the RFA may not exceed
four years.  The earliest feasible start date for the initial awards
will be August 1993.  Although this program is provided for in the
financial plans of the NCI, the award of R01 grants pursuant to this
RFA is also contingent upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

Investigator-initiated grant support is by far the largest single
entity in the NCI research budget.  The NCI utilizes a range of funding
mechanisms to support clinical research efforts of differing scale and
scope.  For the conduct of large-scale, multi-institutional clinical
trials, the Cancer Therapy Evaluation Program has established a program
of integrated national networks of clinical investigators and
institutions (Clinical Trials Cooperative Groups).  The primary
responsibility of the cooperative groups is to perform definitive
evaluation of clinical treatment programs.  These groups have limited
involvement with pilot studies and ancillary laboratory studies, which
bridge the gap between the laboratory and the clinic.  Currently,
translational research and preliminary clinical studies are supported
by grants (R01, P01, and U01 awards) under the Research Project Grant
category.  This smaller scale clinical research is usually done within
single institutions or in small consortia of institutions interested in
a particular area of therapeutic investigation.  These investigator
initiated mechanisms support early clinical development of new
therapeutic agents and treatment modalities.  They support
pharmacokinetics studies, studies of mechanisms of action and
resistance of therapeutic agents, and all types of clinical correlative
studies.  This effort is the essence of translational research, which
brings the basic science to the bedside and provides leads for
definitive treatment trials.

An unprecedented number of new therapeutic agents are ready for
evaluation in pilot clinical studies.  In addition, insights into the
biologic function and clinical relevance of growth factors, genes that
promote and suppress neoplasia, mechanisms of treatment sensitivity and
resistance, and function of the immune system provide important new
clinical research opportunities for investigators.  The NCI is
interested in expanding support for clinical research.  Under this IRPG
RFA, the NCI encourages the coordinated submission of related research
project grant applications from investigators who want to collaborate
on a common cancer research theme, but do not require extensive shared
physical resources or multiple core functions.  This mechanism is not
meant to replace the program project (P01) mechanism but to support a
level of collaboration between that of the P01 and that available
through an individual R01.

The IRPG is defined in PA-92-29 (NIH Guide for Grants and Contracts,
Vol. 21, No. 1, January 10, 1992) as three or more investigator-
initiated research grant applications that are reviewed for independent
merit but that share a theme and resource(s), and that require
concurrent funding to maximize the effectiveness of the resource or to
allow maximal creative interaction between researchers.  Applicants
will benefit from use of the IRPG mechanism by establishing a larger
framework of reference for the proposed work, by facilitating formal
collaborations tailored to achieving research objectives, by providing
a record of independently acquired awards credited to each funded
investigator, and by allowing retention of research autonomy by the
named Principal Investigator on each of the interactive grants.

Research Goals And Scope

The aims of this RFA are two-fold:  (1) to provide support for
translational research that brings innovative basic research findings
into the clinic and (2) to foster the development of interactions
between basic science laboratories of different disciplines and
clinicians performing clinical trials to advance therapeutic clinical
research.

This RFA is soliciting applications to perform IRPGs with the goal of
developing new clinical studies involving systemic therapies with a
therapeutic intent.  The IRPGs may have as their key focus either:  (1)
clinical studies investigating promising therapeutic approaches in a
single tumor type or (2) the development of new clinical treatment
strategies focused on a single class of novel compounds or mechanism of
action.  Each project supported in the IRPG is expected to contribute
to and be directly related to the common theme of the IRPG application.
The application must clearly explain how the projected integrated R01
research grants can be expected to accomplish the stated goal more
efficiently and effectively than they could without the anticipated
interactions.  At least one clinical trial protocol must be proposed in
one of the grant applications.  The clinical trials should be well
integrated with the laboratory studies proposed within the same R01
application or in separate R01 applications.

Support will be provided to institutions with established clinical,
laboratory, and statistical resources.  Some examples of research areas
that individual R01 grant applications would focus on include:  (1)
pre-clinical drug development studies, utilizing in vitro or in vivo
models, leading to new clinical trials; (2) studies to elucidate or
exploit the mechanism of action or resistance of therapeutic agents;
(3) pharmacokinetics and pharmacodynamic studies of new agents or in
combination; (4) clinical correlative studies designed to improve
therapeutic approaches; (5) clinical trials of new systemic therapies
utilizing therapeutic agents alone or in combination with other
modalities.  Investigators are not limited to the above examples of
potential studies.  The NCI encourages investigators to propose other
scientific approaches that suit the interactive R01 mechanism and the
requirements of this RFA.

SPECIAL REQUIREMENTS

Definitions

Principal Investigator (PI) - The person who submits the single R01
grant application in response to this RFA and who is responsible to the
applicant/awardee institution for the scientific and administrative
direction and proper conduct of all aspects of the R01 grant.

Project Coordinator -  The person designated by the PIs of the
interactive R01 grants who is responsible for the overall coordination
of the scientific direction of the interactive R01 grants.

Responsibilities of Each Awardee

Each awardee is responsible for his/her own proposed research
project(s) to advance the goals of the RFA and to define its approaches
to attain these goals.  It is the primary responsibility of the PI to
state clearly the objectives of the research project, to direct the
research stipulated in the application, and to ensure that the results
obtained are published in a timely manner.  It is anticipated that
decisions on the overall scientific direction of the package of
interactive R01s will be reached by consensus of the collaborating PIs.

Responsibilities of the Project Coordinator

In addition to the responsibilities stated above for each awardee, the
Project Coordinator has the responsibility of providing coordination of
the overall scientific direction of the interactive R01s.  He/she will
accomplish this role by facilitating scientific collaborations among
the various investigators.  The Project Coordinator will also be
responsible for establishing mechanisms to facilitate regular
communication and coordination among investigators.

STUDY POPULATIONS

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 females 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 females 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
females 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, together with a rationale for
its choice.  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 the Research Plan, 1-4, 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, 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 includes 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 females 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 females 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
females 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.

LETTER OF INTENT

Prospective applicants are asked to submit, by October 22, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the names and addresses of the Principal Investigators, the
names of other investigators and key personnel, the participating
institutions, and the number and title of the RFA in response to which
the application is being submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, it is requested
in order to provide an indication of the number and scope of
applications to be reviewed.

The letter of intent is to be sent to:

Dr. Roy S. Wu
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

APPLICATION PROCEDURES

The PHS 398 (rev. 9/91) research grant application form is to be used
in applying for this RFA.  These forms are available at most
institutional business offices; from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, Room 449,
Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892, telephone
(301) 496-7441; and from the NCI Program Director named below.

A short narrative of the interactive nature of the research
applications should be included in the Research Plan of each of the R01
applications.  The exact nature of the interactions should be clearly
detailed under the consortium section of the respective R01
applications.

The RFA label available in the PHS 398 research application form must
be affixed to the bottom of the face page.  Failure to use this label
could result in delayed processing of the application such that it may
not reach the review committee in time for review.  In addition, the
RFA number and title must be typed on line 2a of the face page of the
application form.

Submit the signed, typewritten original application, including the
Checklist, and three signed, exact photocopies of each R01.  The
photocopies must be clear and single sided.

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, send two additional copies of each
application to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 838
5333 Westbard Avenue
Bethesda, MD  20892

Applications must be received by December 22, 1992.  If an application
is received after that date, it will be returned without review.  If
the application submitted in response to this RFA is substantially
similar to a research grant application already submitted to the NIH
for review, but has not yet been reviewed, the applicant will be asked
to withdraw either the pending application or the new one.
Simultaneous submission of identical applications will not be allowed,
nor will essentially identical applications be reviewed by different
review committees.  Therefore, an application cannot be submitted in
response to this RFA that is essentially identical to one that has
already been reviewed.  This does not preclude the submission of
substantial revisions of applications already reviewed, but such
applications must include an introduction addressing the previous
critique.

REVIEW CONSIDERATIONS

Review Procedure

Upon receipt, applications will be reviewed by the Division of Research
Grants for completeness.  Incomplete applications will be returned to
the applicant without further consideration.  Evaluation for
responsiveness to the program requirements and criteria stated in the
RFA is an NCI program staff function.  Applications that are judged
non-responsive will be returned to the applicant.  An application
judged to be non-responsive to this RFA may be submitted as an
investigator-initiated IRPG at the next receipt date for unsolicited
applications.  Questions concerning the responsiveness of proposed
research to the RFA are to be directed to program staff (see
INQUIRIES).

If the number of applications submitted is large compared to the number
of awards to be made, the NCI may conduct a preliminary scientific peer
review to eliminate those that are clearly not competitive.  The NCI
will remove from competition those applications judged to be
noncompetitive for award and notify the applicant and institutional
business official.

Those applications judged to be both responsive and competitive will be
further evaluated according to the review criteria stated below for
scientific and technical merit by an appropriate peer review group
convened by the Division of Extramural Activities, NCI.  The second
level of review by the National Cancer Advisory Board considers the
special needs of the Institute and the priorities of the National
Cancer Program.

Review Criteria

The factors considered in evaluating the scientific merit of each
application will be:

o  Extent to which the proposed research addresses the goals of the RFA

o  Scientific, technical, or medical significance and originality of
proposed research within each R01 application;

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

o  Research or clinical experience, training, time availability, and
qualifications of the investigators involved;

o  Adequacy of plans for effective collaboration among laboratory,
clinical, and statistical investigators within each R01;

o  Adequacy of the available resources and environment (e.g.,
facilities, equipment, statistical resources, patient population)

o  Adequacy of the mechanisms for quality control, study monitoring,
data management and reporting, and data analysis;

o  Adequacy of provisions for the protection of human subjects;

o  Adequacy of the plans for inclusion of females and minorities.

The reviewers will also judge the appropriateness of the proposed
budget and duration in relation to the proposed research.  For each
application that is given a priority score, the review group will
assign an adjectival descriptor that reflects the extent and
effectiveness of its collaboration(s) with other applications included
in the IRPG.  This assessment will be documented in a brief
administrative note in the summary statement to assist the NCI in
making final decisions on each application in the context of the
overall IRPG.

AWARD CRITERIA

The anticipated date of award is August 1, 1993.  In addition to the
technical merit of the application, NCI will consider how well the
applicant institution meets the goals and objectives of the program as
described in the RFA, availability of resources, and study populations.

INQUIRIES

Written and telephone inquires concerning the objectives and scope of
this RFA and inquires about whether or not specific proposed research
would be responsive are encouraged and are to be directed to NCI
Program Directors at the addresses below.  The NCI Program Directors
welcome the opportunity to clarify any issues or questions from
potential applicants.

For technical information:

Dr. Roy S. Wu
Ms. Diane Bronzert
NCI Program Director
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

For business information:

Ms. Sara Stone
Grants Management Specialist
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 66
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 Sections 301,
410, and 411, Part A (Public Law 78-410, 42 USC 241 as amended, Public
Law 99-158, 42 USC 285a) 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.