Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials Proceedings of a Workshop (2016) / Chapter Skim
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2 Historical Perspectives and Context
2 Historical Perspectives and Context
Pages 9-18
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THE HISTORICAL AND SOCIAL ORIGINS OF RACE Historically, the concept of race in the United States has had two main components, said Charles Rotimi, chief of the Genomics of etabolic, M C ardiovascular, and Inflammatory Disease Branch and director of the C enter for Research on Genomics and Global Health at the National Human Genome Research Institute of NIH. One component has been based on biogenetic variation determined in part by a person's biogeographic ancestry.
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As modern humans encountered more archaic populations of humans outside Africa, they sometimes mated with members of these groups and added fragments of their DNA to the DNA they carried out of Africa. As Rotimi said, "One of the things that humans do very well is, whenever we travel, we are very generous in sharing our DNA." Because of this history, most of the oldest genetic differences among people are found in all human populations.
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THE DRAWBACKS OF MANDATED INCLUSION Otis Brawley, chief medical officer for the American Cancer Society and professor of hematology, oncology, medicine, and epidemiology at Emory University, took what he described as a somewhat contrarian view of race and ethnicity in clinical trials, while agreeing with the overall need to broaden participation. He said that he worries when legislators require analyses of subgroups in clinical trials.
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Disadvantaged African Americans who have colon cancer tend to get treated in hospitals that are overcrowded and stressed, where pathologists will look at just 3 to 5 lymph nodes for signs of cancer rather than 18 to 24, Brawley said. As a result, the belief took shape that black cancer patients had more aggressive colon cancer.
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There is no racial difference if you are from an institution that that person trusts." As health care enters an era of precision medicine, the genetic markers a person has will be much more important than a person's race or ethnicity, said Brawley, concluding that "It is not the width of one's nose or the color of one's skin. It is what genes are active." HISTORICAL PERSPECTIVES ON MEANINGFUL INCLUSION Amelie Ramirez, professor of epidemiology and biostatistics, founding director of the Institute for Health Promotion Research, and associate director of cancer prevention and health disparities at the Cancer Therapy and Research Center, all at the University of Texas Health Science Center at San Antonio, briefly reviewed the history of clinical trials and efforts to broaden participation in trials.
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documented major strides that have been made in the areas of breast cancer, cervical cancer, and heart disease. But that report also identified conditions where progress is still needed, including unintended pregnancy, maternal morbidity and mortality, autommune i diseases, alcohol and drug addiction, lung cancer, gynecologic cancers (noncervical)
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But now I know there are clinical trials for all stages of breast cancer." Ramirez explained that when patients were asked about what would enable them to participate in a clinical trial, several factors were prominently cited, including • Trusting the doctor • Trusting the trial center • Feeling that joining a trial will give hope and help future cancer patients • Having clear information • Encouragement from family members For example, one patient said, "To know that every new medicine goes through a clinical trial puts me and my family more at ease and gives us more options if we get sick." In a test of three registry recruitment methods among South Texas Hispanics into the Cancer Genetics Network, one randomized group received a letter from their doctors asking them to participate, another received the letter plus a culturally tailored bilingual brochure, and the third received the letter, brochure, and interpersonal contact to urge them to participate. The result was that extra information and interpersonal contact increased accrual, reported Ramirez.
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Ramirez made two additional suggestions to increase Latino participation in clinical trials, based on her experiences and observations. Computerbased videos, if specifically tailored to Latina breast cancer patients, are a particularly effective strategy to increase patients' knowledge and understanding of clinical trials and to promote their participation in clinical research.
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From page 17... ...
Rotimi also pointed out that the optimal population to enroll in a clinical trial depends on the questions being asked. For some questions, a genomically uniform population might be better, while for others a heterogeneous population would be better.
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