Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials Proceedings of a Workshop (2016) / Chapter Skim
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1 Introduction and Highlights of the Workshop
1 Introduction and Highlights of the Workshop
Pages 1-8
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Federal legislation has sought to increase the representation of minorities and women in clinical trials,2 but legislation by itself has not been sufficient to overcome the many barriers to greater participation. Only much broader changes will bring about the meaningful participation of all population groups in the clinical research needed to improve health.
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HEALTH DISPARITIES AND CLINICAL TRIALS In his introductory remarks at the workshop, National Academy of Medicine President Victor Dzau said, "The issue of eliminating health disparities is essential to our society, to all of us, and certainly to me." Dzau was born in postwar China, where he observed poverty and disparities firsthand, and he has worked extensively on disparities issues as a researcher and administrator at Duke University. "The health field is not just about health care," he said.
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This legislation mandated that, within 1 year of enactment, FDA would provide to Congress and post on the FDA website a report on the extent of clinical trial participation and on the quality of analyses to determine safety and effectiveness for demographic subgroups included in applications submitted to FDA, while taking into account FDA 3 The FDA Safety and Innovation Act of 2012, although primarily focused on the reauthorization of user fees for pharmaceutical companies, also contained a provision, Section 907, that directs these companies to improve demographic subgroup data's completeness, quality, and availability.
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But FDA policy now explicitly states "The database submitted in a marketing application should reflect usage in a diverse racial population, one reflective of the likely patient mix postmarketing, for potential differences in response to become apparent." The challenge, said Bull, is to implement this policy and execute it well. 4 An FDA website provides updates of the agency's activities related to Section 907 of the legis lation: http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/ FDASIA/ucm389100.htm (accessed July 1, 2015)
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Estimating the treatment effect within a group or the heterogeneity of treatment effect across groups is critical, which raises the question of which drugs or other medical products need to be identified early for special consideration for subgroups. • What steps can FDA and NIH take in working together with academia and industry to ensure the meaningful participation of diverse groups in clinical trials?
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. • The recruitment and retention of participants in clinical trials are multifaceted problems that involve funders, researchers, health care providers, patients, advocacy groups, and the public interest (C.
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Chapter 3 examines some of the scientific issues that arise in efforts to achieve clinically meaningful inclusion, such as the size of the subgroups needed to produce useful results and how best to involve communities in scientific research. Chapter 4 looks at some of the barriers to participation posed by health care providers, institutions, and systems, such as the difficulties in achieving informed consent and the mistrust created by historical abuses.
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