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									Developing More Effective Clinical Research Models to Address Cancer Disparities in the United States
Frank Govern, Ph.D. Cancer Disparities Research Partnership Program (CDRP) National Cancer Institute Cancer Health Disparities Summit July 17, 2006

The Context
6% 9% 12.5%







NA 1.5% A/PI 4.2%

Source: United States Census Bureau, Current Population Survey, 1960-2000

Source: Baseline “Study of Patient Accrual Onto Publicly Sponsored Trials,” Coalition of Cancer Cooperative Groups for the Global Access Project, April 2006.

Of the 35 Million Americans receiving medical treatment each year, 85% receive their care in community hospital settings.

The Challenge
Creating unique, non-traditional research models and funding mechanisms: * to accelerate research discoveries in minority populations and * to translate those advances into clinical delivery to those populations.

Changing the Funding Paradigm
Traditional CDRP

Telemedicine Linkages

Mentor Relationship

Regional Comprehensive Cancer Center

Urban/Rural Hospital Serving Target Populations

Local Urban/Rural Hospitals Serving Target Populations

Any Comprehensive Cancer Center

CDRP: Supporting the Nation’s Goal of Eliminating Health Disparities
• Unique $25M, 5-year research grant (2008) program in Radiation Oncology
– Increase minorities on clinical trials. – Increase clinical and translational scientists studying cancer disparities. – Develop new institutions embedded in minority communities for long-term research efforts. – Explore the applications of telemedicine. – Investigate new areas of clinical and social health disparities research. – Bring to a level of competitive application for ongoing funding.

CDRP Target Populations
African Americans Native Americans Asians Hispanics/Latinos Native Alaskans Pacific Islanders Those of low socioeconomic status.

CDRP Funding
Specialized Infrastructure
• • telemedicine/teleconferencing networking/communication expenses

Administrative Core
• •

equipment, supplies, administrative support personnel mentor/partnership support

Developmental Core
• • • •

research projects support for data management and research nursing training and education outreach/trials recruitment

Mentor & Relationship

Mentor • NCI-designated Cancer Centers • Cooperative Group participating institutions Partnership Plan • By end of 1st year – Submission and approval of detailed Partnership Plan. • By end of 2nd year – Full implementation of Partnership Plan.


Clinical Trials
• •


Submission of Pilot Clinical Trials with Application Year 1: • Build Clinical Trials Infrastructure • Define Mentor Role • Refine Clinical Trials • IRB Approval Year 2: • Begin accrual of patients onto clinical trials

Selection Process
Award Award PI & Mentor PI & Mentor Abilities Abilities Quality of Program Quality of Program Peer Review Process Peer Review Process Incidence/Mortality > National Average Incidence/Mortality > National Average % Target Population > State Average % Target Population > State Average $100K or less of previous NCI Funding $100K or less of previous NCI Funding Community Hospital with Up-To-Date Facilities and Expertise Community Hospital with Up-To-Date Facilities and Expertise

CDRP Award Recipients
Rapid City Regional Hospital Cancer Care Institute, Rapid City, SD
Serves over 100,000 Native Americans from Pine Ridge, Cheyenne River and Rosebud Reservations. Pine Ridge is poorest county in U.S. Primary Mentor: University of Wisconsin Cancer Center

Laredo Medical Center, Sanchez Cancer Center, Laredo, TX
Community 95% Hispanic/Latino with 35% of its residents living in poverty, one of the highest poverty rates in the U.S. Primary Mentor: University of Texas, San Antonio

Singing River Hospital, Regional Cancer Center, Pascagoula, Mississippi
Primary provider of cancer care to the Gulf Coast, serves African Americans from the poorest counties in Mississippi and Mobile County in Alabama. Primary Mentor: University of Alabama Cancer Center

CDRP Award Recipients (Continued)
New Hanover Regional Medical Center, Wilmington, North Carolina
Serves a poor population located in 9 counties in southeastern North Carolina where 22.5% of the population is African American and 28% of them live in poverty. Mentor: University of North Carolina Cancer Center

Centinela Freeman Health System, Inglewood, California
45% of inner city hospital’s patient population are African American and 45% are Hispanics/Latinos. Primary Mentor: University of Southern California Cancer Center

UPMC-McKeesport Hospital, McKeesport, Pennsylvania
Targets isolated, rural poor of western Pennsylvania and inner city African Americans of Allegheny County. Primary Mentor: Washington University Mallincrodt Institute

TELESYNERGY® Telemedicine System

Cancer Disparities Research Partnership Program

Active CDRP Clinical Trials (6 Sites)

PI Initiated Protocols (16) Cooperative Group Trials (40)

Total CDRP Program Accrual By Research Type
Research Type
Patients on Clinical Trials Total 2002 0 2003 0

2004 23 2005 65 2nd Quarter 2006 82 Total 170

Patient Navigated Total

2002 0

2003 428

2004 164

2005 604

2nd Quarter 2006 391

Total 1587

Social Science Studies Total

2002 0

2003 68

2004 800

2005 520

2nd Quarter 2006 171

Total 1559

Preventive Clinical Trial (Laredo) Total

2002 0

2003 300

2004 9

2005 0

2nd Quarter 2006 0

Total 309

Clinical Trials - Centinela Freeman Health System PI - Michael Steinberg, MD
Name of Trial Prostate Patient Profiles Project (P4) “A Study to determine the genetic alterations that cause prostate cancer and related diseases.” RTOG 0413 - Study of Conventional Whole Breast Irradiation versus Partial Breast Irradiation for Women with Stage O, I or II Breast Cancer RTOG 0232 “Comparing Combined External Beam Radiation and Transperineal Interstitial Brachytherapy with Brachytherapy Alone for Select Patients w/Intermediate Risk Prostatic Carcinoma RTOG 0321”Phase II Trial of Combined High Dose Rate Brachtherapy and External Beam Radiotherapy for Adenocarcinoma of the Prostate RTOG 98-04 “Phase III Trial of Observation+/- Tamoxifen vs. RT +/Tamoxifen for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast” RTOG 0315 “A Randomized, Double Blind, Placebo-Controlled Phase III Study to Determine the Effectiveness of Sandostatin LAR Depot in Preventing or Reducing the Severity of Chemoradiation-Induced Diarrhea in Patients with Anal or Rectal Cancer Sponsor Louis Warschaw Prostate Cancer Center @ Cedars Sinai National Cancer Institute

National Cancer Institute

National Cancer Institute National Cancer Institute

National Cancer Institute

CFHS Accrual to Trial by Ethnicity
18 16 14 12 10 8 6 4 2 0 African Americans Latinos Caucasians Asians 3 3 1 16

CFHS Accrual to Trial by Gender
16 14 12 10 8 6 4 2 0 Men Women 8 15

Trials Accrual– Rapid City Regional Medical Center
PI- Daniel Petereit, MD Total number of Native Americans entered on trials since program opened June 2004:
– – – – – Cancer Attitudes and Beliefs Survey: 20 Community Survey on Cancer Knowledge: 604 Ataxia Telangectasia Gene Mutation (ATM) Study: 10 CDRP treatment trials: 5 Cooperative Group Trials: 6


Next Steps for CDRP Program
• 2006- 2008– Comprehensive evaluation of program by contractor (NOVA Research) • 2006 – Conduct Preliminary Evaluation • End of 2006 - Modify and improve CDRP Program in new RFA. • 2007 - Apply to NCI to reissue competing renewal of CDRP Program.

Examples of CDRP Metrics
• • • • • “Significant” increase in the number of all patients on study at the end of 5 years. The provision of stage appropriate therapy. Establishment of additional multi-modality clinics. Number of papers and abstracts (co)authored by researchers. The health and activity of the institution’s long-term affiliation with Cooperative Groups, the Comprehensive Cancer Center and NCI. Use of TELESYNERGY® to enhance clinical decision.


Success is: 1) solid disparities clinical research and 2) funding past the life of the grant.

James Doroshow, M.D. Norman Coleman, M.D. Rosemary Wong, Ph.D. Luis Cordiero Aaron Taye Robert Martino, Ph.D. Kenneth Kempner, M.S. Michael Steele, M.S.
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