Overview

The United States has long made substantial investments in clinical research with the goal of improving the health and well-being of our nation. There is no doubt that these investments have contributed significantly to treating and preventing disease and extending human life. Nevertheless, clinical research faces a critical shortcoming. Currently, large swaths of the U.S. population, and those that often face the greatest health challenges, are less able to benefit from these discoveries because they are not adequately represented in clinical research studies. While progress has been made with representation of white women in clinical trials and clinical research, there has been little progress in the last three decades to increase participation of racial and ethnic minority population groups. This underrepresentation is compounding health disparities, with serious consequences for underrepresented groups and for the nation. At the request of Congress, Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups identifies policies, procedures, programs, or projects aimed at increasing the inclusion of these groups in clinical research and the specific strategies used by those conducting clinical trials and clinical and translational research to improve diversity and inclusion. This report models the potential economic benefits of full inclusion of men, women, and racial and ethnic groups in clinical research and highlights new programs and interventions in medical centers and other clinical settings designed to increase participation. Table of Contents Front Matter Summary 1 The Committee's Task 2 Why Diverse Representation in Clinical Research Matters and the Current State of Representation within the Clinical Research Ecosystem 3 Policies to Improve Clinical Trial and Research Diversity: History and Future Directions 4 Barriers to Representation of Underrepresented and Excluded Populations in Clinical Research 5 Facilitators of Successful Inclusion in Clinical Research 6 Recommendations for Improving Representation in Clinical Trials and Clinical Research Epilogue: Envisioning a New Future References Appendix A: Quantifying the Potential Health and Economic Impacts of Increased Trial Diversity Appendix B: Key Trends in Demographic Diversity in Clinical Trials Appendix C: Improving Representativeness in Clinical Trials and Research: Facilitators to Recruitment and Retention of Underrepresented Groups

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