BUREAU RECEIVES SECOND "SAFETY NET" AWARD IN TWO YEARS 
 

On June 23, the National Association of Public Hospitals & Health Systems announced the recipients of the 1999 Safety Net Awards, which recognize hospital-based programs that improve the delivery of health care services to poor and medically underserved communities. Dr. Robert Weinstein, Bureau Director of Infectious Diseases, received the Clinical Research Award for work on infectious diseases, including the epidemiology and control of antibiotic resistance in vulnerable populations. 

This is the second consecutive year that a Bureau staff member has been recognized. In 1998, the Safety Net Health System Innovation Award was given to Patricia Terrell, Deputy Bureau Chief, for her work in establishing partnerships with Bethany Hospital and St. Anthony Hospital to deliver maternal child care in their local communities.
 

MINORITY CANCER RESEARCH: INSTITUTE OF MEDICINE REPORT

The Institute of Medicine, in a report commissioned by Congress two years ago, suggests that more federal funds need to be devoted to studying cancer in minority groups. The report, "The Unequal Burden of Cancer: An Assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved.", reviews the disparities in both cancer mortality and in the incidence of certain cancers among different racial 

and ethnic groups. The authors credit the National Institutes of Health with the development in recent years of a number of initiatives aimed at dealing with these disparities, but also argue for more focused funding. Another major recommendation is that the current classification by traditional racial groups is not the best or most appropriate way to study these disparities. They propose developing a classification system that uses information about particular ethnic groups and socioeconomic status to be used instead.

One section of particular interest to Bureau investigators deals with the difficulties of enrolling minority patients into cancer treatment and prevention trials. The report discusses a number of reasons why recruitment of minorities is not always successful, including the barriers created by the current health care system:
 

"Structural issues within the health care research industry also pose challenges to the recruitment of ethnic minority and medically underserved individuals. Many urban, low-income, uninsured, underinsured, or ethnic minority individuals receive treatment in large public hospitals, as opposed to private hospitals or university-affiliated research hospitals. The latter often capture a larger share of federal research dollars. Increasingly, time and financial constraints prevent many physicians working in public hospital settings from participating in research projects and enrolling their patients as subjects.

"Researchers working with lower-income and minority communities may also face greater costs in conducting research as a result of the need to address financial barriers to participation in clinical trials. Recruitment often requires more than placing ads in newspapers; researchers must expend resources to build relationships with community groups and hire outreach personnel. Clinical trial participants often must visit a doctor's office or clinic regularly, which for some entails transportation and child-care costs, which typically are not covered by federal research grants. Some research programs have offered meals as a means of assisting low-income patients' participation.

"Thus, a combination of historical experience and unequal access to health care has created a dynamic of mistrust on the part of ethnic minority and medically underserved communities and , in many quarters, resignation to low levels of participation in clinical research among investigators and health practitioners."

One way the National Cancer Institute has attempted to deal with patient recruitment is with a system of Community Clinical Oncology Programs (CCOPs) designed to bring the benefits of clinical research to cancer patients in their own communities by providing support for physicians to enter patients onto research protocols. In an effort to increase minority enrollment, the National Cancer Institute also funds several Minority-Based CCOPs which concentrate on enrollment of minority individuals into these trials. The purpose of the Minority-Based CCOPs is "to support as a national resource those physicians involved in the care of minority cancer patients who are available for treatment and cancer prevention and control clinical trials research."

The Institute of Medicine report found that, overall, the CCOPs have succeeded in recruiting minorities into clinical treatment trials in representative numbers, but not into trials designed to prevent cancer:

"In CCOP prevention trials, the rate of accrual of ethnic minorities was poor. Data provided by NCI revealed that of the 4,172 patients enrolled in prevention trials, 289 (6.9 percent of the total) were ethnic minorities. Only 5 of the 51 CCOPs were able to enroll ethnic minority patients at rates equivalent to the proportion of ethnic minorities living in the states in which CCOP's were located. Furthermore, only the Miami Beach and Tampa sites were able to enroll ethnic minority subjects at rates of one-third or more of the total subject population...

"The eight MBCCOPs [Minority-Based Community Clinical Oncology Programs] appear to have increased the numbers of ethnic minority patients in the overall CCOP pool, yet in some cases they have not performed better than the CCOPs accruing the highest numbers of ethnic minorities...Overall, 79 percent of the patients enrolled in MBCCOP treatment trials were ethnic minorities, whereas 58 percent of the subjects enrolled in prevention trials were ethnic minorities.

The same pattern held for large-scale prevention trials developed by the National Cancer Institute. Of the five large-scale prevention trials reviewed in the report, only one achieved proportional representation of minorities among its enrollees. As an example, one of the trials reviewed was a study of the effect of tamoxifen in preventing breast cancer in high risk women:

"...BCPT is a randomized, double-blind trial that will assess whether the drug tamoxifen can prevent breast cancer in women at increased risk of developing the disease. More than 13,000 women were recruited from nearly 180 sites for this trial, managed by the National Surgical Adjuvant Breast and Bowel Project.

"...BPCT recently yielded data suggesting that tamoxifen may be an effective chemopreventive agent for women at increased risk of breast cancer. This trial, however, which included more than 13,000 women, performed extremely poorly with respect to the accrual of ethnic minorities. Of the 13,266 women enrolled in the trial, 12, 630 (95.2 percent) were white, 275 (2.1 percent) were African American, 163 (1.2 percent) were Hispanic, 112 (0.8 percent) were Asian or Pacific Islander, and 33 (0.2 percent) were Native American. ... for African Americans and Hispanics the rates of accrual to BCPT were fourfold and almost threefold less, respectively, than the national breast cancer incidence."

The report emphasizes that it is impossible to say whether economically-disadvantaged or medically underserved patients are under represented in these trials. This is because data about patients' income, educational level, or medical insurance status are rarely available. One exception is from the PCPT trial, a nation wide prostate cancer prevention trial. Data collected on socioeconomic indicators suggests that the participants were by and large well-educated and middle class:

"PCPT did, however, provide data on the characteristics of other participants, such as levels of education and income, that may be relevant for targeting cancer control interventions. Of the total sample, 4 percent reported that they had some high school education or less, 15 percent reported only a high school degree, 30 percent reported vocational training or some college education, 16 percent reported a college (bachelor's) degree, and 35 percent reported postgraduate education. The median annual income reported by the sample is $32,000, with 42 percent reporting incomes of $30,000 or less, 49 percent reporting incomes between $30,000 and $50,000, and 9 percent reporting incomes of greater than $50,000."

The report notes that accrual of African Americans in this trial was very poor, about 2.5 times lower than the national incidence of prostate cancer for this population. Does a pattern of recruiting well-educated, relatively well-off patients into prevention trials contribute to the low minority representation in these trials? To what extent are there barriers to minority participation in prevention trials that may not exist in treatment trials? The answers are not known, but it is likely there will be research to find out.

The Institute of Medicine report is only part of a growing movement to look at the factors that contribute to the "unequal burden" referred to in the report's title. The American Cancer Society this spring announced an initiative to study cancer in poor and underserved populations, and more recently the Centers for Disease Control announced the first program in a new federal initiative to erase racial and ethnic disparities in health status by the year 2010. There will certainly be more to come. 
If you would like to see a summary of the Institute of Medicine report, as well as information for ordering it, go to http://www.nap.edu/catalog/6377.html

You may also order the report by writing to the National Academy Press, 2101 Constitution Avenue, Washington, DC 20418.

From the Chronicle of Philanthropy:

"The Open Society Institute will spend $15-million over three years to fight what the philanthropist George Soros sees as the corrupting influence of money in medicine...

"A new grant-making program, called Medicine as a Profession will bring together medical and consumer organizations to monitor and improve health care to insure that ethical considerations, not just financial ones, govern patient care."

If you're interested in knowing more about this initiative, go to http://www.soros.org/usprograms/medicine.htm or call 212-548-0312.

From the June 16 NIH Guide:

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces that a portion (1/3) of all stored non-renewable samples (plasma, serum, urine) from subjects enrolled in the Diabetes Control and Complications Trial (DCCT) is available for use by the scientific community to address questions for which these samples are uniquely invaluable. The DCCT was a randomized, controlled clinical trial conducted at 29 centers in the U.S. and Canada. A total of 1,441 patients between the ages of 13 and 39 years with insulin-dependent diabetes for 1-15 years 
were recruited during 1983 through 1989. 
 

During the course of the study, blood (plasma and serum) and urine samples were obtained at baseline and annually for up to 10 years. For each available subject at baseline and yearly intervals thereafter, the NIDDK is prepared to release up to 4.5 ml urine, 1 ml serum, and 1 ml plasma per requestor. The NIDDK will support the costs of aliquotting and distributing these samples from the central laboratory for highly meritorious approved projects. This does not include DNA or lymphocyte samples. Associated demographic and clinical data on patients, including retinopathy, nephropathy, and neuropathy status, can be made available from the Biostatistics Center at George Washington University.

For more information contact:

Catherine C. Cowie, PhD
Director, Type 1 Diabetes Clinical Trials Program
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 5AN24A
Bethesda, MD 20892-6600
Telephone: (301) 594-8804
FAX: (301) 480-3503

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[A long-term calendar showing most of the major academic medical society meetings can be found on the web at: http://www.aamc.org/meetings/mjmtgcal.htm] 

Balancing the Belmont: Human Subjects and Future Research is a conference sponsored by OPRR, FDA and a group of Michigan universities, to be held September 15-17 in Ypsilanti, Michigan. For more information call 313-577-5601. 

Outcome Evaluation for Nonprofit Organizations (July 20, August 4 and August 26), and 
The ABCs of Proposal Preparation and Writing(July 29-30, August 11-12, September 16-17) will be offered by the Donors Forum of Chicago in its offices at 208 South LaSalle Street, Suite 735. For more information call 312-578-0090. 
 
 

Office of Research Development Workshops 

These workshops are open to any County-affiliated investigator or grant-seeker. Enrollment for some sessions is limited, so please register only for those you will be able to attend. 

Grant Writing Seminar:

Gives an overview of the entire process of developing a project and applying for funding. Includes information on approaching both governmental and private funders, describes an approach to developing grant budgets, discusses stylistic and content issues that are frequent stumbling blocks in writing grant applications.

Constructing a Grant Budget:

Covers many of the technical aspects of developing an accurate time line and budget for a grant proposal.

What Are All These Forms? Interacting With the Scientific Committee: 

Gives an orientation to procedures -- and the associated forms -- used by the Scientific Committee to 
ensure that patients are protected from undue risks in research. The Bureau forms will be discussed, and new policies and changes in federal regulations will be covered.

To register for any of these, call Bennetta Anderson at 312-633-4941. If you would like to schedule one or more of these workshops in your Department or at another site, please call Karen Smith at 633-4940. 
 
 

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To have the NIH Guide sent automatically to your e-mail address every week, click on the LISTSERV link on this page and follow the instructions.

To ask specific questions about NIH grant programs, send e-mail to: grantsinfo@nih.gov 
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These are one time only opportunities. Call 312-633-4940 to check for due dates or to get copies of full announcements

NATHAN SHOCK CENTERS OF EXCELLENCE IN BASIC BIOLOGY OF AGING (RFA-AG-99-008) National Institute on Aging

URINARY INCONTINENCE TREATMENT NETWORK (RFA-DK-99-001) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Child Health and Human Development

CARCINOGENICITY OF DRINKING WATER DISINFECTION BY-PRODUCTS
(RFA-ES-99-007) National Institute of Environmental Health Sciences

HIV VACCINE CLINICAL TRIAL UNITS
(RFA-AI-99-009) National Institute of Allergy and Infectious Diseases

HIV PREVENTION TRIAL UNITS
(RFA-AI-99-010) National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, National Institute of Mental Health, National Institute on Drug Abuse

SUPPORT FOR THE ANNUAL MARC/MBRS BIOMEDICAL RESEARCH SYMPOSIUM (RFA-GM-99-008) National Institute of General Medical Sciences

SPECIALIZED COOPERATIVE CENTERS PROGRAM IN REPRODUCTION RESEARCH (RFA-HD-99-009) National Institute of Child Health and Human Development

HEALTH CARE MARKETS AND MANAGED CARE (RFA-HS-00-001)
Agency for Health Care Policy and Research

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NIH PROGRAM ANNOUNCEMENTS 
(PA'S): These are ongoing funding priorities, with due dates usually October 1, February 1 and June 1 of each year. Note that HIV-related applications are due January 2, May 1 and September. Past PA's, many of which are still open, can be searched at the NIH Guide web site.

MECHANISMS OF ALCOHOL-INDUCED HEPATIC FIBROSIS (PA-99-110) National Institute on Alcohol Abuse and Alcoholism

NATIONAL EYE INSTITUTE SUPPORT OF SCIENTIFIC MEETINGS (PA-99-125)
National Eye Institute
 

NICHD SMALL GRANTS PROGRAM
(PAR-99-126) National Institute of Child Health and Human Development

SHARED RESOURCES FOR SCIENTISTS OUTSIDE NCI CANCER CENTERS
(PAR-99-127) National Cancer Institute

INSIGHT AWARDS TO STAMP OUT BREAST CANCER (PAR-99-128) National Cancer Institute

RESEARCH CORE CENTERS (P30) FOR THE NIDCD (PAR-99-129) National Institute on Deafness and Other Communication Disorders 
THERAPEUTICS RESEARCH ON AIDS-ASSOCIATED OPPORTUNISTIC INFECTIONS (PA-99-124) National Institute of Allergy and Infectious Diseases

DRUG USE AND RELATED ADVERSE BEHAVIORAL AND SOCIAL CONSEQUENCES (PA-99-113)
National Institute on Drug Abuse

REVIEW AND ANALYSIS OF TOBACCO INDUSTRY DOCUMENTS (PAR-99-114)
National Cancer Institute

DEVELOPMENT OF NONMAMMALIAN MODELS AND RELATED BIOLOGICAL MATERIALS FOR RESEARCH (PAR-99-115) National Center for Research Resources

INSULIN SIGNALING AND RECEPTOR CROSS TALK (PAS-99-112) National Institute of Diabetes and Digestive and Kidney Diseases

NIMH THERAPEUTIC EFFECTIVENESS PROTOCOL DEVELOPMENT PROGRAM
(PAR-99-119) National Institute of Mental Health

GENETICS OF NEUROBEHAVIORAL DISORDERS IN EXISTING SAMPLES
(PA-99-120) National Institute of Mental Health, National Institute of Child Health and Human Development

RISK FACTORS FOR PSYCHOPATHOLOGY USING EXISTING DATA SETS (PA-99-121)
National Institute of Mental Health

THE AGING SENSES: RELATIONSHIPS AMONG MULTIPLE SENSORY SYSTEMS
(PA-99-123) National Institute on Aging, 
National Institute of Child Health and Human Development, National Institute on Deafness and Other Communication Disorders, National Institute of Dental and Craniofacial Research, 
National Institute of Diabetes and Digestive and Kidney Diseases, National Eye Institute, National Institute of Neurological Disorders and Stroke

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August 18
SURVEILLANCE OF NEW VACCINE PREVENTABLE DISEASES, Centers for Disease Control and Prevention (404-639-8254 or http://www.cdc.gov) 

August 18
SENTINEL HOSPITAL SURVEILLANCE AND EPIDEMIOLOGY OF GASTROENTERITIS IN CHILDREN, Centers for Disease Control and Prevention (404-639-8715 or http://www.cdc.gov) 

August 11
RESEARCH ON MENTAL DISORDERS IN HOMELESS WOMEN, Substance Abuse and Mental Health Services Administration (301-443-3706 or http://www.samhsa.gov)

January 15, 2000
FACULTY DEVELOPMENT IN WOMEN'S HEALTH, Society for Women's Health Research and Pfizer Women's Health (202-223-8224 or http://www.womens-health.org)

August 5
HIV PREVENTION AMONG GAY MEN OF COLOR, Centers for Disease Control and Prevention (404-639-5280 or http://www.cdc.gov) 

August 6
PREVENTION NEEDS OF HIV-SEROPOSITIVE DRUG INJECTORS, Centers for Disease Control and Prevention (404-639-1914 or http://www.cdc.gov) 

August 15
NON-INVASIVE DIAGNOSIS OF STDS IN YOUNG ASSAULTED FEMALES, Centers for Disease Control and Prevention (404-639-3467 or http://www.cdc.gov)

August 11
COMMUNITY-BASED PRACTICE/RESEARCH COLLABORATION, Substance Abuse and Mental Health Services Administration (301-443-8796 or http://www.samhsa.gov) 

September 1
CYSTIC FIBROSIS RESEARCH, Cystic Fibrosis Foundation (800-FIGHT-CF, or http://www.cff.org/research32.htm)

Open (letter of intent)
CANCER RESEARCH, Cancer Treatment Research Foundation (847-342-6484 or http://www.ctrf.org)

4 funding cycles/year
MINI-GRANTS FOR MEDICAL OR DENTAL SERVICE, Volunteers in Health Care (877-844-8442 or http://www.volunteersinhealthcare.org)

August 13
TEEN RESPONSIBILITY, EDUCATION, ACHIEVEMENT, CARING AND HOPE, Illinois Department of Human Services (217-785-4630 or http://www.state.il.us/agency/dhs)
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