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Minority and Underserved in Clinical Trials: NCI Programs to … · 2009-03-13 · Minority...
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Minority and Underserved in Clinical Trials: NCI Programs to Enhance Accrual Worta McCaskill-Stevens, MD,MS Division of Cancer Prevention National Cancer Institute National Institutes of Health HHS
Transcript of Minority and Underserved in Clinical Trials: NCI Programs to … · 2009-03-13 · Minority...
Minority and Underserved in Clinical Trials: NCI Programs to Enhance Accrual
Worta McCaskill-Stevens, MD,MSDivision of Cancer Prevention
National Cancer InstituteNational Institutes of Health
HHS
1993 NIH Revitalization Act
Inclusion of: • Women and minorities and their subpopulations in
all clinical research• Minorities in phase III trials so that valid analysis
of differences in intervention effects can be performed
• Cost is not an acceptable reason for exclusion• NIH initiate programs and support for outreach to
recruit and retention
Underrepresented Populations
Elderly Treatment: 70+ (5-7%)Prevention: 70+ (9%)
AdolescentsLower Socioeconomic statusRural AreasAfrican AmericansHispanics/LatinosAsian Americans American Indians
Today’s Presentation
• Accrual in the Clinical Trials Network
• Beyond “Bean Counting”• Enhancing the Infrastructure• Generating Research Questions
• Trans NCI Initiatives
NCI Clinical Trials Network
• NCI Cancer Centers (64), other academic centers
• Community Clinical Oncology Program (47)
• Minority-Based Clinical Oncology Program (13)
• Cancer Disparities Research Partnership Program (5)
• NCI Community Cancer Centers Program (16)
• OMB Directive 15 issued in 1997:
•Created racial and ethnic standards for Federal statistics and administrative reporting
Minority Enrollment to NCI (CTEP, DCP, RRP) Clinical Trials
35,314 36,557
32984
8986
1612
32,304
40,26038,608
46,948
36,412
32,552
7,5477,4427,4009,1798,3728,892
6,7225,494
13751206102610159301144102810840
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
50,000
FY2000 FY2001 FY2002 FY2003 FY2004 FY2005 FY2006 FY2007 FY2008
Majority Minority Unknown or Not Reported
14%
83%
82%
82%
81%
80%
81%
78% 76%
16% 17% 18%
81%
16% 18%21%
15% 17%
Minority Enrollment on NCI (CTEP, DCP, RRP) Clinical Trials by Race
2 3 16 54 7283 121 110 115 152255
222235180125
1,024886948871
575
450145134721
3281
2851
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
5,000
FY2000 FY2001 FY2002 FY2003 FY2004American Indian or Alaska AsianBlack or African American More than one raceNative Hawaiian or Other PacificIslander
Minority Enrollment on NCI (CTEP, DCP, RRP) Clinical Trials by Race
52 73 59 51102 106 94 106209233207199
12091,0901,0611,022
3955
334033553567
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
FY2005 FY2006 FY2007 FY2008American Indian or Alaska AsianBlack or African American More than one raceNative Hawaiian or Other PacificIslander
Enrollment on NCI (CTEP, DCP, RRP) Clinical Trials by Ethnicity
3,3292,8283,0612,2941,900
44,80843,639
52,911
41,085
35,601
2,3171,4431,0127831,629
0
10,000
20,000
30,000
40,000
50,000
60,000
FY2000 FY2001 FY2002 FY2003 FY2004
Hispanic or Latino Not Hispanic or Latino Unknown
Enrollment on NCI (CTEP, DCP, RRP) Clinical Trials by Ethnicity
3,5862,8512,7642,574
37,06935,278
39,19038,597
2,9273,0973,2512,569
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
FY2005 FY2006 FY2007 FY2008
Hispanic or Latino Not Hispanic or Latino Unknown
21,823
583 547 463 546 680
21,79919,89420,731
19,687
4,1763,7823,5243,3133,087
0
5,000
10,000
15,000
20,000
25,000
FY2004 FY2005 FY2006 FY2007 FY2008
Total Accrual Minority Accrual Unknown
16% 16% 16% 19% 19%
466 396403435284
3,7803,379
3,0892,8472,803
0
500
1000
1500
2000
2500
3000
3500
4000
FY2004 FY2005 FY2006 FY2007 FY2008
CTSU Others
9% 14% 12% 11% 9%
91% 86%
88% 89%
91%
Accrual to CTEP Treatment Phase III Clinical Trials
CTSU vs. Others
Minority Enrollment on NCI (CTEP, DCP, RRP) Clinical Trials
For Patients 70 and Older
8,447 8,633
6296
940196
6,7287,415
10,551
12,107
9,719
6,915
709 7941,240 1,534 1,326 1,053 1,060 810
166 215 285 229 203 188 191 1630
2,000
4,000
6,000
8,000
10,000
12,000
14,000
FY2000 FY2001 FY2002 FY2003 FY2004 FY2005 FY2006 FY2007 FY2008
Majority Minority Unknown or Not Reported
89%
9%
88%
9%
87%
10%
87%
11%
86%
12%
87%
11%
87%
11%
88%
10%
85%
13%
Minority Enrollment on NCI (CTEP, DCP, RRP) Clinical Trials
For Patients 65 and Older
80%
8,495 8,703
6,869
1,031
193
7,110
8,5438,281
7,0287,201 7,020
863 996 870 799 913 1,072 1,119 968
198 225 283 230 251 227 162 1530
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
FY2000 FY2001 FY2002 FY2003 FY2004 FY2005 FY2006 FY2007 FY2008
Majority Minority Unknown or Not Reported
87%
87% 88%
87% 86%
87% 87%
86% 85%
11% 10% 9% 10% 11% 11% 11% 12% 13%
13 Funded MBCCOPs
• SUNY Downstate Medical Center, NY• John Stroger Cook Co., IL• Louisiana State University, LA• Louisiana State University, LA• Medical College of Georgia, GA• Meharry Medical, TN • Gulf Coast, AL• South Texas Pediatrics, TX• San Juan, PR• University of Hawaii, HI• University of Illinois, IL• University of New Mexico, NM• Va. Commonwealth U., VA
Impact of MBCCOPS on Clinical TrialsMinority-Based CCOPS
Grant/Fiscal Year# of Funded MBCCOPS
Treatment Accrual Prevention & Control Accrual
Overall Accrual # of Minority Patients
% Minority Overall
2000 8 425 358 783 446 57 %
2001 10 642 541 1183 676 57 %
2002 11 567 682 1249 901 72 %
2003 11 521 930 1451 1088 75 %
2004 13 673 467 1140 674 59 %
2005 13 709 428 1137 579 51 %
2006 13 684 393 1077 602 56%
2007 14 805 776 1581 965 61%
Total (2000 – 2007) 5,026 4,575 9,601 5,931
Community Clinical Oncology Program (CCOPS)
2000 51 6241 4872 11,113 938 8 %
2001 50 6328 7936 14,264 991 7 %
2002 50 5257 6373 11,630 888 8 %
2003 50 5269 6963 12,232 1,038 8 %
2004 50 6729 4871 11,600 1,095 9 %
2005 50 7239 4783 12,022 846 7 %
2006 50 5718 4601 10,319 974 9 %
2007 49 5533 6020 11,553 1,115 10%
Total (2000 – 2007) 48,314 46,419 94,733 7,885
NCI Community Cancer Centers Program:Clinical Trials
• Goals:• Increase Accrual to all trials• Accrual focus:
• Minorities and Underserved• Multimodality and early phase trials
10 Organizations Selected
• 6 Community Hospitals• Hartford Hospital, Connecticut• St. Joseph’s/Candler, Georgia • Our Lady of the Lake Regional Medical Center, Louisiana*• Spartanburg Regional Hospital, South Carolina*• St. Joseph Hospital, Orange, California• Christiana Hospital, Delaware*
• 2 Rural Hospitals – Native Americans• Billings Clinic, Montana*• Sanford USD Medical Center, South Dakota*
• 2 National Health Systems – Multistate with multiple program locations• Ascension Health: Indianapolis, Milwaukee and Austin• Catholic Health Initiatives: Towson, MD; Colorado Springs and 3 sites in
Nebraska* • * CCOPMBCCOP or affiliation
Presenter
Presentation Notes
10 organizations were selected from across the county 6 are community hospitals in both urban and semi-rural areas 2 are rural hospitals that include Native American populations And 2 are national health systems These were included to study how these organizations disseminate information and practices of the program to developmental sites that do not meet the baseline criteria. Ascension Health includes a lead site in Indianapolis, and developmental sites in Milwaukee and Austin Catholic Health Initiative includes 2 lead hospitals, one in Towson, Maryland and the other in Colorado Springs, and 3 developmental sites in Nebraska So although 10 organizations are funded, there are 16 sites participating in the pilot
NCCCP All Clinical Trials Accrual
43 67
2052
2468
1904
0
500
1000
1500
2000
2500
3000
Baseline (7/1/2006-6/30/07) Year 1 (7/1/2007-6/30/2008) Year 2 (7/1/2008-12/31/2008*
Minority Total
NA
NCCCP NCI Cooperative Group Trials
96 7521
746
622
171
27 5913
184
492
85
0100
200300
400500
600700
800
Baseline (7/1/2006-6/30/07) Year 1 (7/1/2007-6/30/2008) Year 2 (7/1/2008-9/30/2008*
Treatment Minority Treatment TotalCancer Control & Prevention Minority Cancer Control & Prevention Total
Beyond “Bean Counting”
Addressing Comorbidity
• Refining tools to assess comorbidity in older patients
• Expanding trials to include patients with comorbidity
K-ras Mutations and Colon Cancer Benefits from Cetuximab
Karapetis. NEJM 2008, Cutsem, ASCO 2008
• Among minorities with colon ca: Higher incidence of regional & distant disease; higher mortality
• Ongoing Trials:MBCCOP CCOP
C80405 90 448N0147 130 854
• Research Questions: • Prognosis vs. Prediction• Interaction with co-morbidity (adherence)• Sensitivity of assay; community/central concordance
Target: 2,289Accrual: 1,429
% Min. accrual= 22
• What data should be collected to • Improve clinical outcomes?• Interpret clinical outcomes?
• Data suggests SES influences clinical outcomes• IOM, Singh, Lantz, HHH PRG Health Disparities
• Currently, we collect zip codes and insurance status: SES or surrogates are not routinely collected
• Consideration for the future trials• Education• Census Tract information
MBCCOP Mentoring Case Report
• Private Practitioner in San Juan , PR with staff to support practice
• Participating site in SELECT
• Accrued 1000 + men
• San Juan MBCCOP Mentoring:Data managementIRB accessAudit preparation
Center for Health Disparities& Other Partners
• Patient Navigator Program• Partnership (MBCCOP, CCOPs, NCCCP, Cancer
Centers)
• Community Network Program• Education and collaboration with clinical trials network
• Baquet, et al., Analysis of Maryland Cancer Patient Participation in National Cancer Institute–Supported Cancer Treatment Clinical Trials, JCO, 2008
• ENACCT (Ed. Network to Advance Ca Clinical Trials
Minorities in Chemoprevention Trials
Total Enrollment/% Minority Enrollment/%
BCPT6/1992-9/1997
13,388
RAF: 98,018
3.7AA 220 (1.7)Other 319 (2.0)RAF: 5,530
PCPT1/1994-5/1997
18,882 8.0Black 723 (4)Other 767 (4)
STAR7/1999-11/2004
19,747
RAF: 184,461
6.5AA 474 (2.4)Hispanic 384 (2.0)RAF: 28,910
SELECT8/2001-6/2004
35,534 21.0Black 5,256 (15)Asian 474 (1)Hispanic (5)
Trans-NCI Clinical Trials Accrual Working Group (CTAWG) Goals
• Foster collaboration and information sharing of clinical trials accrual initiatives among the NCI Centers, Offices, Divisions and Programs that review, support, and fund clinical trials.
• Develop initiatives that promote successful clinical trial accrual practices
CTAWG Goals (cont.)
• CTAWG is exploring holding an interactive workshop in 2010 on clinical trial accrual strategies
• CTAWG with OCE is investigating how sites might use an interactive web site of evidenced-based accrual strategies.
Promotional materials to assist in recruitment
Impact of Programs Enrolling Minorities and Underserved in Cancer Clinical Trials
• Serve as training ground for oncologists and related disciplines in oncology practices
• Laboratories for identifying preclincal, clincal and behavioral issues
• Collection of tissue for advanced technologies, (i.e., pharmacogenomics)
• Enrich literature on research, recruitment, retention and overall improvement in cancer clinical care in underserved populations.
