Health_ Clinical Trials Participation

Breaking Down the Barriers: Improve Minority Health, Clinical Trials Participation James H. Powell, MD, CPI Principal Investigator Increase Minority Participation and Awareness of Clinical Trials (IMPACT) The National Medical Association Clinical Trial  Medical research studies conducted with volunteers. Each study is designed to answer scientific questions and to find better ways to prevent, detect, or treat human medical conditions. Number of Participants in US Clinical Trials Annually (2004) 1,000 850 725 750 Thousands of People 500 0 Industry-Funded Clinical Trials (Phases I-III) Industry-Funded Clinical Trials (Phase IV) Government-Funded Clinical Trials Source: CISCRP, 2005; NIH & FDA reports Clinical Trials for Drug Development     Phase I: Safety, tolerability, drug behavior (pharmacokinetics) in small number of healthy volunteers Phase II: Drug effectiveness in a small number of patients Phase III: Confirmation of drug safety and effectiveness in large number of patients, establish support for labeling Phase IV: Trials conducted in patients for additional safety, claims support Why we should be concerned about diversity    Clinical trials form the basis of modern medical practice Racial and ethnic minorities remain underrepresented in clinical trials Current processes may select for therapies which meet needs of people of Western European descent Population Shifts Percent of Population by Race and Hispanic Origin, 2000 vs. 2050 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 2000 2050 American Indian/ Alaska Native Asian/ Pacific Islander Black/ African American Hispanic/Latino White % of Population Diversity in Drug Response     Multiple genes involved in causing disease Genes involved in drug absorption, metabolism, elimination, and drug effect Genetic variation may be associated with race Nutritional, environmental, lifestyle influence on drug response Well-known Recent Cases   Serevent in SMART Trial (Salmeterol Multicenter Asthma Research Trial) – Revealed increased mortality in AfricanAmericans BiDil – treatment for heart failure in African-American Race/Ethnicity of Clinical Trial Participants from 185 New Drug Applications (NDAs)* Total Enrolled 1995-1999 (n=493,347) 47% 53% Race Determ ined * From Medical Reviewers Reports Race Undeterm ined Clinical Trials Participants by Race for NDAs 1995-1999* (n=263,704)* 1% 8% 3% 0% 88% White Asian Black Am . Ind. Hispanic * From medical reviewers comments. Excludes 229,643 patients where race/ethnicity was not described Source: Evelyn et al; JNMA, vol. 93, no. 12, December, 2001. Potential Consequences     Low minority presence in the “evidence” for evidence-based medical practice Limited guidance on use of therapeutic interventions in diverse patient populations Gaps in data supporting personalized medicine Risk therapeutic solutions that are “out of touch” with the US population Regulations Addressing Minority Inclusion in Clinical Trials     Guidelines for the Inclusion of Women and Minorities in NIH Clinical Trials, 1993 Food and Drug Modernization Act of 1997, Recommends inclusion, documentation of race and ethnicity, requires analysis Do current regulations support safe and effective therapeutics for minority patients? Regulatory Agency Contributions to Limited Inclusion     No penalties for lack of diversity Products approved without data from diverse populations with disease Product labels often fail to recognize potential for diversity in responses Regulations facilitate ease of use of non US populations Sponsor’s Contributions to Limited Inclusion   Poor community relationships Investigator selection biases:    Expanding use of non-US investigators Academic sites with small pools of minority academic researchers Limited industry use of minority investigators   Cultural sensitivity not considered for investigators See clinical trial inclusion as social, not medical issue Physician Contributions to Barriers  Stereotyping and bias towards people, communities, avoid “tough” discussions Bias about research involvement, don’t recommend to patients    Concerns about loss of patients Inadequate Cross Cultural Education Inadequate time to invest in individual and community relationships  Other Barriers to Minority Participation in Clinical Trials       Less access to healthcare Cultural beliefs or myths about disease, clinical trials Negative experiences with the health care system Scarcity of culturally and linguistically-appropriate materials and strategies Literacy issues “Mistrust” of medical research Historical Perspective: Evolution of Mistrust in the African-American Community   Health Disparities: At no point in the history of America have individuals of African descent experienced equity in health No single point in history is the source of mistrust of the health care system “You’ll be happy to know that race played no part in this decision.” Historical Perspective   Medical experimentation on African slaves who had no rights under the law to resist Example: Multiple gynecologic surgeries conducted in slave women without anesthesia by Dr. Marion Sims, the “father” of gynecology, and published in medical literature Historical Perspective  Robbery of Black graves for cadavers to use in medical education “Night Doctors”  The US Public Health Service Study of Syphilis in the Negro Male  Cited as the major factor behind mistrust of medical and public health ~400 men with syphilis allowed to remain untreated for 40 years   Many African-Americans believe the government infected the men Medical journal publications over the 40 years Discontinued after disclosure in lay press   The Legacy of the Syphilis Study The “Tuskegee Syphilis Study” has emerged as the most prominent example of medical racism, and often quoted reason for mistrust of research because it confirms, if not authenticates, long-held and deeply entrenched beliefs within the African American community. Recent Perspective  Racial and ethnic minorities agree to participate at similar rates as whites   Harris Interactive Poll (2002)(www.harrisinteractive.com/news/news letters_healthcare.asp ) Wendler, Kington et al (www.plosmedicine.org; February, 2006) The Effect of “Mistrust”  Concerns regarding ability to communicate across cultural barriers, inappropriate research involvement contribute to delays in seeking medical attention among African-Americans Jacobs et al; J Gen Intern Med. 2006;21(6):642-647  Overcoming the Barriers       Support culturally competent healthcare delivery Support culturally and linguistically appropriate education of patients and consumers Avoid blaming patients for their mistrust as it perpetuates a stereotype, punishes patients Avoid allowing mistrust to become the excuse for poor investment of effort Support the sharing of knowledge regarding differences in drug response The future demands a new paradigm of partnering with the community for effective education and conduct of research Cultural Competency refers to the ability to honor and respect the beliefs, language, interpersonal styles, and behaviors of individual and families receiving services, as well as staff who are providing such services.” National Center for Cultural Competence Physician-Patient Communications         Respect Language and salutations Office location Office décor Waiting room materials Office personnel Office hours Addressing family members Conclusion     Poor guidance derived from a paucity of relevant data threatens a healthier future and may perpetuate health disparities All parties have a role in improving the trustworthiness of healthcare and clinical research for broader participation Cultural competence and diverse involvement at all levels is key Culturally and linguistically appropriate strategies for achieving diversity in clinical trials should be mandatory The National Medical Association Project IMPACT James H. Powell, MD, CPI jpowell@nmanet.org (202)347-1895 www.nmanet.org)