Minority Inclusion in Clinical Trials

Transcription

1 Minority Inclusion in Clinical Trials Otis W. Brawley, MD, MACP, FASCO,FACE Chief Medical and Scientific Officer American Cancer Society Professor of Hematology, Medical Oncology, Medicine and Epidemiology Emory University Atlanta, Georgia, USA

2 Disclosures Employment: American Cancer Society Emory University Turner Broadcasting (CNN) Consulting National Institutes of Health Centers for Disease Control Department of Defense

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4 History Minority Health Special Populations Research Health Disparities

5 Disparities in Health The concept that some populations (however defined) do worse than others. Populations can be defined or categorized by: Gender Race Ethnicity and Culture Area of geographic origin Socioeconomic Status

6 The NIH Revitalization of 1993 Mandated inclusion Mandated comparison of differences amongst races Why I opposed Coersion onto trials Mistaken findings AZT Moves the emphasis off problem

7 Disparities in outcomes Biological Issues - Confusing familial genetics and racial genetics Social Issues Poor have lots of things not on their side

8 My Concern For most diseases equal treatment yields equal outcomes among equal patients. Race is not the appropriate category unless one is assessing quality of care. There is not equal treatment. There is not enough concern about nor emphasis on the fact that there is not equal treatment.

9 Equal Treatment Yields Equal Outcome There is not Equal Treatment Studies suggest that disparities in treatment may be due to: Cultural differences in acceptance of therapy. Disparities in comorbid diseases making aggressive therapy inappropriate. Lack of convenient access to therapy. Racism and SES discrimination.

10 Breast Cancer Quality of Care Receipt of minimum expected care in SEER- Medicare data Blacks less likely % CI ( ) Hispanics less likely % CI ( ) Haggstrom, Cancer 2005

11 Breast Cancer The Reality In 2000, 7.5% of Black Women in Atlanta diagnosed with localized highly curable breast cancer did not receive a surgical removal of the tumor. A substantial number of women of all races and incomes get less than optimal breast cancer care!!!! Provision of adequate care is a logistical issue and not new medical science. Lund et al, Cancer 2007

12 Notes Data is available in the early 1990 s for Hispanics, NH Blacks and NH Whites Data is not available other minority groups

13 Cancer Distribution 1991 to 1994 Proportion with Cancer Proportion in Trials NHBlacks 9.4% 2.6% Hispanics 3.4% 4.2% NH Whites 87.2% 2.4% Total 100% 2.5% Tejeda et al, JNCI 88, 1996

14 The National Cancer Institute Clinical Cooperative Groups Part of NCI Clinical trials program which enrolled over 20,000 cancer patients per year to treatment trials and cancer prevention trials. Minority Based Community Clinical Oncology Program- 12 sites

15 Key Factors The nature of the the study (Treatment vs Prevention Trials) The study population (pediatric versus adult) The reputation in the community of the enrolling center.

16 Cancer Distribution 1991 to 1994 Pediatric Patients Proportion with Cancer Proportion in Trials NHBlacks 12.4% 63.0% Hispanics 11.9% 71.4% NH Whites 75.7% 72.2% Total 100% 71.0% Tejeda et al, JNCI 88, 1996

17 Cancer Distribution 1991 to 1994 Adult Patients 50+ Proportion with Cancer Proportion in Trials NHBlacks 9.1% 1.4% Hispanics 2.9% 1.3% NH Whites 88.0% 1.5% Total 100% 1.5% Tejeda et al, JNCI 88, 1996

18 Breast Cancer Adults NH Blacks Hispanics NH Whites Cases in Trials 8.6% 2.5% 88.9% Cases in US 7.4% 2.7% 89.9% Tejeda et al, JNCI 88, 1996

19 Prostate Cancer Adults NH Blacks Hispanics NH Whites Cases in Trials 14.7% 2.5% 82.8% Cases in US % 87.1% Tejeda et al, JNCI 88, 1996

20 Leukemia Adults NH Blacks Hispanics NH Whites Cases in Trials 8.2% 3.3% 88.9% Cases in US 7.3% 2.7% 90.0% Tejeda et al, JNCI 88, 1996

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22 Clinical Intervention Trials Robinson 1994 Drug maintenance (schizophrenia) McKay 1995 Day hospital vs. inpatient (substance abuse) CAST 1996 Drug trial (cardiac arrhythmia) Rimer 1996 Risk counseling (breast cancer) WEST 1996 Estrogen treatment (cardiovascular disease) MBCOOP 1997 Drug trial (cancer) Concorde 2000 Drug trial (HIV infection) Delta 2000 Drug trial (HIV infection) Westerberg 2000 Treatment trial (alcohol abuse) COMS 2001 Radiation Therapy (ocular melanoma) Wendler et al, PLoS Medicine, 2006

23 Comparison of African-American versus non-hispanic White Consent Rates Circle diameter is proportional to the sample size of the individual studies. The diamond represents the overall OR. The vertical line indicates the 95% confidence interval on the OR. Blue indicates interview and non-intervention studies; red indicates clinical intervention studies. Wendler et al, PLoS Medicine, 2006

24 Comparison of Hispanic versus non-hispanic White Consent Rates Circle diameter is proportional to the sample size of the individual studies. The diamond represents the overall OR. The vertical line indicates the 95% confidence interval on the OR. Blue indicates interview and non-intervention studies; red indicates clinical intervention studies. Wendler et al, PLoS Medicine, 2006

25 Surgical Intervention Trials CASS 1984 Surgery vs. medical management (angina pectoris) Paradise 1984 Tonsillectomy vs.tonsillectomy with adenoidectomy (recurrent throat infection) Williford 1993 TPN (post-surgery malnourishment) Marcus 1997 Surgery vs. medical management (recurrent otitis media) EAST 1997 PTCA vs. CABG (coronary artery disease) SHOCK 1999 Surgery vs. medical management (myocardial infarction with shock) BARI 2000 PTCA vs. CABG (coronary artery disease) Wendler et al, PLoS Medicine, 2006

26 Comparison of Minority versus non-hispanic White Consent Rates in Surgical intervention Trials. Circle diameter is proportional to the sample size of the individual studies. The diamond represents the overall OR. The vertical lines indicates the 95% confidence interval on the OR. Wendler et al, PLoS Medicine, 2006

27 Key Factors in Trial Participation The nature of the the study (Treatment vs Prevention Trials) The study population (pediatric versus adult) The reputation in the community of the enrolling center.

28 Key Factors in Outcome Social issues Receipt of care Quality of care Precision Medicine Following genetic markers Tailoring treatment to the patient (not the race!!!!)

29 Otis W. Brawley, MD, MACP, FASCO, FACE Chief Medical and Scientific Officer American Cancer Society Professor of Hematology, Medical Oncology, Medicine and Epidemiology Emory University 29