Strategies For Ensuring Diversity Inclusion And Meaningful Participation In Clinical Trials

Even as the U.S. population becomes steadily more diverse, minorities and women remain underrepresented in clinical trials to develop new drugs and medical devices. Although progress in increasing minority participation in clinical trials has occurred, participation rates do not fully represent the overall population of minorities in the United States. This underrepresentation threatens the health of both these populations and the general population, since greater minority representation could reveal factors that affect health in all populations. Federal legislation has sought to increase the representation of minorities and women in clinical trials, 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. To examine the barriers to participation in clinical trials and ways of overcoming those barriers, the National Academies of Sciences, Engineering, and Medicine held a workshop in April 2015. This publication summarizes the presentations and discussions from the workshop.

Even as the U.S. population becomes steadily more diverse, minorities and women remain underrepresented in clinical trials to develop new drugs and medical devices. Although progress in increasing minority participation in clinical trials has occurred, participation rates do not fully represent the overall population of minorities in the United States. This underrepresentation threatens the health of both these populations and the general population, since greater minority representation could reveal factors that affect health in all populations. Federal legislation has sought to increase the representation of minorities and women in clinical trials, 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. To examine the barriers to participation in clinical trials and ways of overcoming those barriers, the National Academies of Sciences, Engineering, and Medicine held a workshop in April 2015. This publication summarizes the presentations and discussions from the workshop.

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.

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

The COVID-19 pandemic is only the latest prompt about the importance of international health and its broad influence upon social wellbeing. The COVID-19 pandemic has highlighted the need for an informed and coordinated effort to achieve international healthcare equity. Leaders in international health must be conversant in its issues. Contemporary Issues in Global Medicine and Moving Toward International Healthcare Equity provides an understanding of contemporary issues in international medicine. It explores the impact of civil unrest on population health and provides practical strategies for providing clinical care in low resource settings. Covering topics such as international public health, maternal health, and drug resistance, this book is an essential resource for government officials, medical officials, physicians, nurses, social workers, sociologists, epidemiologists, medical students, students and educators of higher education, researchers, and academicians.

Racial and ethnic disparities in health care are known to reflect access to care and other issues that arise from differing socioeconomic conditions. There is, however, increasing evidence that even after such differences are accounted for, race and ethnicity remain significant predictors of the quality of health care received. In Unequal Treatment, a panel of experts documents this evidence and explores how persons of color experience the health care environment. The book examines how disparities in treatment may arise in health care systems and looks at aspects of the clinical encounter that may contribute to such disparities. Patients' and providers' attitudes, expectations, and behavior are analyzed. How to intervene? Unequal Treatment offers recommendations for improvements in medical care financing, allocation of care, availability of language translation, community-based care, and other arenas. The committee highlights the potential of cross-cultural education to improve provider-patient communication and offers a detailed look at how to integrate cross-cultural learning within the health professions. The book concludes with recommendations for data collection and research initiatives. Unequal Treatment will be vitally important to health care policymakers, administrators, providers, educators, and students as well as advocates for people of color.

The pervasiveness of technology today has brought with it a bevy of ethical questions, many of which are difficult to answer. Average consumers place themselves at risk financially, professionally, and personally by everyday activities executed on computers and smartphones, and therein lies the responsibility of technologists and decision-makers to devise logical and ethical solutions. Exploring Ethical Problems in Today’s Technological World focuses on ethical dilemmas created by today's ever-changing technologies and how these issues have affected individuals, companies, and society. The book further explores key areas such as policies, abuses, consequences, and responsibilities of different technologies and their users. Covering topics such as hackers, smart homes, privacy, and social networking, this reference work is ideal for ethicists, computer scientists, policymakers, industry professionals, researchers, academicians, practitioners, and students studying ethics, law, security, human-computer interaction, and computer science.

The United States is rapidly transforming into one of the most racially and ethnically diverse nations in the world. Groups commonly referred to as minorities-including Asian Americans, Pacific Islanders, African Americans, Hispanics, American Indians, and Alaska Natives-are the fastest growing segments of the population and emerging as the nation's majority. Despite the rapid growth of racial and ethnic minority groups, their representation among the nation's health professionals has grown only modestly in the past 25 years. This alarming disparity has prompted the recent creation of initiatives to increase diversity in health professions. In the Nation's Compelling Interest considers the benefits of greater racial and ethnic diversity, and identifies institutional and policy-level mechanisms to garner broad support among health professions leaders, community members, and other key stakeholders to implement these strategies. Assessing the potential benefits of greater racial and ethnic diversity among health professionals will improve the access to and quality of healthcare for all Americans.

In order for the United States to maintain the global leadership and competitiveness in science and technology that are critical to achieving national goals, we must invest in research, encourage innovation, and grow a strong and talented science and technology workforce. Expanding Underrepresented Minority Participation explores the role of diversity in the science, technology, engineering and mathematics (STEM) workforce and its value in keeping America innovative and competitive. According to the book, the U.S. labor market is projected to grow faster in science and engineering than in any other sector in the coming years, making minority participation in STEM education at all levels a national priority. Expanding Underrepresented Minority Participation analyzes the rate of change and the challenges the nation currently faces in developing a strong and diverse workforce. Although minorities are the fastest growing segment of the population, they are underrepresented in the fields of science and engineering. Historically, there has been a strong connection between increasing educational attainment in the United States and the growth in and global leadership of the economy. Expanding Underrepresented Minority Participation suggests that the federal government, industry, and post-secondary institutions work collaboratively with K-12 schools and school systems to increase minority access to and demand for post-secondary STEM education and technical training. The book also identifies best practices and offers a comprehensive road map for increasing involvement of underrepresented minorities and improving the quality of their education. It offers recommendations that focus on academic and social support, institutional roles, teacher preparation, affordability and program development.