TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Robert Graham A2 - Nicole F. Kahn TI - Promoting Positive Adolescent Health Behaviors and Outcomes: Thriving in the 21st Century SN - DO - 10.17226/25552 PY - 2020 UR - https://nap.nationalacademies.org/catalog/25552/promoting-positive-adolescent-health-behaviors-and-outcomes-thriving-in-the PB - The National Academies Press CY - Washington, DC LA - English KW - Behavioral and Social Sciences KW - Health and Medicine AB - Adolescence is a critical growth period in which youth develop essential skills that prepare them for adulthood. Prevention and intervention programs are designed to meet the needs of adolescents who require additional support and promote healthy behaviors and outcomes. To ensure the success of these efforts, it is essential that they include reliably identifiable techniques, strategies, or practices that have been proven effective. Promoting Positive Adolescent Health Behaviors and Outcomes: Thriving in the 21st Century identifies key program factors that can improve health outcomes related to adolescent behavior and provides evidence-based recommendations toward effective implementation of federal programming initiatives. This study explores normative adolescent development, the current landscape of adolescent risk behavior, core components of effective programs focused on optimal health, and recommendations for research, programs, and policies. ER - TY - BOOK AU - Institute of Medicine TI - Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life SN - DO - 10.17226/18748 PY - 2015 UR - https://nap.nationalacademies.org/catalog/18748/dying-in-america-improving-quality-and-honoring-individual-preferences-near PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - For patients and their loved ones, no care decisions are more profound than those made near the end of life. Unfortunately, the experience of dying in the United States is often characterized by fragmented care, inadequate treatment of distressing symptoms, frequent transitions among care settings, and enormous care responsibilities for families. According to this report, the current health care system of rendering more intensive services than are necessary and desired by patients, and the lack of coordination among programs increases risks to patients and creates avoidable burdens on them and their families. Dying in America is a study of the current state of health care for persons of all ages who are nearing the end of life. Death is not a strictly medical event. Ideally, health care for those nearing the end of life harmonizes with social, psychological, and spiritual support. All people with advanced illnesses who may be approaching the end of life are entitled to access to high-quality, compassionate, evidence-based care, consistent with their wishes. Dying in America evaluates strategies to integrate care into a person- and family-centered, team-based framework, and makes recommendations to create a system that coordinates care and supports and respects the choices of patients and their families. The findings and recommendations of this report will address the needs of patients and their families and assist policy makers, clinicians and their educational and credentialing bodies, leaders of health care delivery and financing organizations, researchers, public and private funders, religious and community leaders, advocates of better care, journalists, and the public to provide the best care possible for people nearing the end of life. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Morgan L. Boname A2 - Amanda Wagner Gee A2 - Anne B. Claiborne TI - Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary SN - DO - 10.17226/23438 PY - 2016 UR - https://nap.nationalacademies.org/catalog/23438/advancing-the-discipline-of-regulatory-science-for-medical-product-development PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine TI - Fostering Healthy Mental, Emotional, and Behavioral Development in Children and Youth: A National Agenda SN - DO - 10.17226/25201 PY - 2019 UR - https://nap.nationalacademies.org/catalog/25201/fostering-healthy-mental-emotional-and-behavioral-development-in-children-and-youth PB - The National Academies Press CY - Washington, DC LA - English KW - Behavioral and Social Sciences AB - Healthy mental, emotional, and behavioral (MEB) development is a critical foundation for a productive adulthood. Much is known about strategies to support families and communities in strengthening the MEB development of children and youth, by promoting healthy development and also by preventing and mitigating disorder, so that young people reach adulthood ready to thrive and contribute to society. Over the last decade, a growing body of research has significantly strengthened understanding of healthy MEB development and the factors that influence it, as well as how it can be fostered. Yet, the United States has not taken full advantage of this growing knowledge base. Ten years later, the nation still is not effectively mitigating risks for poor MEB health outcomes; these risks remain prevalent, and available data show no significant reductions in their prevalence. Fostering Healthy Mental, Emotional, and Behavioral Development in Children and Youth: A National Agenda examines the gap between current research and achievable national goals for the next ten years. This report identifies the complexities of childhood influences and highlights the need for a tailored approach when implementing new policies and practices. This report provides a framework for a cohesive, multidisciplinary national approach to improving MEB health. ER - TY - BOOK AU - National Research Council TI - Meeting Critical Laboratory Needs for Animal Agriculture: Examination of Three Options SN - DO - 10.17226/13454 PY - 2012 UR - https://nap.nationalacademies.org/catalog/13454/meeting-critical-laboratory-needs-for-animal-agriculture-examination-of-three PB - The National Academies Press CY - Washington, DC LA - English KW - Agriculture KW - Biology and Life Sciences AB - Outbreaks of animal disease can have catastrophic repercussions for animal agriculture, the food supply, and public health. Rapid detection, diagnosis and response, as well as development of new vaccines, are central to mitigating the impact of disease outbreaks. The proposed National Bio- and Agro-Defense Facility (NBAF) is a next-generation laboratory for animal disease diagnostics, training, and research that would provide core critical components for defense against foreign animal and zoonotic disease threats. But it will be a major investment with estimated construction costs of $1.14 billion, as currently designed. Meeting Critical Laboratory Needs for Animal Agriculture: Examination of Three Optionsdiscusses the laboratory infrastructure needed to effectively address the threat posed by animal and zoonotic diseases and analyzes three options for creating this infrastructure: building NBAF as currently designed, building a scaled-back version of the NBAF, or maintaining current research capabilities at Plum Island Animal Disease Center while leveraging biosafety level-4 large animal capabilities at foreign laboratories. ER - TY - BOOK AU - National Research Council TI - Facing Hazards and Disasters: Understanding Human Dimensions SN - DO - 10.17226/11671 PY - 2006 UR - https://nap.nationalacademies.org/catalog/11671/facing-hazards-and-disasters-understanding-human-dimensions PB - The National Academies Press CY - Washington, DC LA - English KW - Behavioral and Social Sciences KW - Earth Sciences KW - Conflict and Security Issues AB - Social science research conducted since the late 1970's has contributed greatly to society's ability to mitigate and adapt to natural, technological, and willful disasters. However, as evidenced by Hurricane Katrina, the Indian Ocean tsunami, the September 11, 2001 terrorist attacks on the United States, and other recent events, hazards and disaster research and its application could be improved greatly. In particular, more studies should be pursued that compare how the characteristics of different types of events—including predictability, forewarning, magnitude, and duration of impact—affect societal vulnerability and response. This book includes more than thirty recommendations for the hazards and disaster community. ER - TY - BOOK AU - National Research Council TI - Improving Student Learning: A Strategic Plan for Education Research and Its Utilization SN - DO - 10.17226/6488 PY - 1999 UR - https://nap.nationalacademies.org/catalog/6488/improving-student-learning-a-strategic-plan-for-education-research-and PB - The National Academies Press CY - Washington, DC LA - English KW - Education AB - The state of America's schools is a major concern of policymakers, educators, and parents, and new programs and ideas are constantly proposed to improve it. Yet few of these programs and ideas are based on strong research about students and teachers—about learning and teaching. Even when there is solid knowledge, the task of importing it into more than one million classrooms is daunting. Improving Student Learning responds by proposing an ambitious and extraordinary plan: a strategic education research program that would focus on four key questions: How can advances in research on learning be incorporated into educational practice? How can student motivation to achieve in school be increased? How can schools become organizations capable of continuous improvement? How can the use of research knowledge be increased in schools? This book is the springboard for a year-long discussion among educators, researchers, policy makers, and the potential funders—federal, state, and private—of the proposed strategic education research program. The committee offers suggestions for designing, organizing, and managing an effective strategic education research program by building a structure of interrelated networks. The book highlights such issues as how teachers can help students overcome their conceptions about how the world works, the effect of expectations on school performance, and the particular challenges of teaching children from diverse and disadvantaged backgrounds. In the midst of a cacophony of voices about America's schools, this book offers a serious, long-range proposal for meeting the challenges of educating the nation's children. ER - TY - BOOK AU - Institute of Medicine TI - Forum on Drug Discovery, Development, and Translation: 2014 Annual Report DO - 10.17226/26115 PY - 2015 UR - https://nap.nationalacademies.org/catalog/26115/forum-on-drug-discovery-development-and-translation-2014-annual-report PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - In 2014, the National Academies’ Forum on Drug Discovery, Development, and Translation (the Forum) convened a workshop to advance the development of more structured approaches to characterize and communicate uncertainty in the assessment of benefits and risks of pharmaceutical products. The Forum membership continued its focused effort to address challenges in the U.S. clinical trials enterprise, facilitating an action-oriented, collaborative dialogue to advance development of harmonized standards for clinical trial sites. For more information, please see https://www.nationalacademies.org/our-work/forum-on-drug-discovery-development-and-translation. ER - TY - BOOK AU - Institute of Medicine A2 - Jill Eden A2 - Rosemary Stevens TI - Evaluating the HRSA Traumatic Brain Injury Program SN - DO - 10.17226/11600 PY - 2006 UR - https://nap.nationalacademies.org/catalog/11600/evaluating-the-hrsa-traumatic-brain-injury-program PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - A traumatic brain injury (TBI)—a brain injury caused by a sudden jolt, blow, or penetrating head trauma that disrupts the function of the brain—can happen to anyone. The effects of a TBI vary from person to person, depending on the force dynamics of injury and the patient's anatomy and physiology. People with TBI-related disabilities and their family members and caregivers need comprehensive, coordinated, person-centered systems of care that attend to their changing needs long after their acute injury has been treated medically. At least 5.3 million Americans are estimated to have a TBI-related disability. The Health Resources and Services Administration's (HRSA) TBI Program, initially authorized by the Traumatic Brain Injury Act of 1996 (P.L. 104-106) and reauthorized by the Children's Health Act of 2000 is a modest federal program with broad ambitions: a $9 million grants program aimed at motivating states to create systems improvement on behalf of persons with TBI with disabilities and their families. In 2004, the federal Office of Management and Budget (OMB) questioned the effectiveness of the HRSA TBI Program, noting that there had been no regular independent evaluations of the program's effects on TBI patients and their families. To address these concerns, HRSA contracted with the Institute of Medicine (IOM) in the spring of 2005 to conduct a study: (1) to assess the impact of the HRSA Program on how state systems are working or failing to work in support of individuals with TBI; and (2) to advise HRSA on how it could improve the program to best serve individuals with TBI and their families. The IOM appointed an 11-member Committee on Traumatic Brain Injury to perform the study. This report presents the IOM Committee on Traumatic Brain Injury's assessment of the HRSA TBI Program's impact and recommendations for improving the program. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine TI - Forum on Drug Discovery, Development, and Translation: 2015 Annual Report DO - 10.17226/26116 PY - 2016 UR - https://nap.nationalacademies.org/catalog/26116/forum-on-drug-discovery-development-and-translation-2015-annual-report PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - In 2015, the National Academies’ Forum on Drug Discovery, Development, and Translation (the Forum) convened a workshop to explore a forward-looking agenda for bolstering the field of innovative regulatory science. The Forum membership continued its focused effort to address challenges in the drug discovery and development process by facilitating an action-oriented collaborative that identified rate-limiting steps in the drug development enterprise and facilitated dialogue for potential process improvement efforts in the biomedical innovation ecosystem. For more information, please see https://www.nationalacademies.org/our-work/forum-on-drug-discovery-development-and-translation. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine TI - Forum on Drug Discovery, Development, and Translation: 2016 Annual Report DO - 10.17226/26117 PY - 2017 UR - https://nap.nationalacademies.org/catalog/26117/forum-on-drug-discovery-development-and-translation-2016-annual-report PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The National Academies’ Forum on Drug Discovery, Development, and Translation (the Forum) convened a workshop to explore a forward-looking agenda for generating and incorporating real-world evidence into the development of therapeutics. The Forum membership continued its effort to address challenges in the drug discovery and development process by facilitating an action-oriented collaborative that identified rate-limiting steps and facilitated dialogue on how to improve processes within the biomedical innovation ecosystem. The Forum also hosted public workshops on genetic bioresources for drug discovery and seamless cancer-focused drug development. For more information, please see https://www.nationalacademies.org/our-work/forum-on-drug-discovery-development-and-translation. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Megan Snair TI - Flourishing in Adolescence: A Virtual Workshop: Proceedings of a Workshop SN - DO - 10.17226/25940 PY - 2020 UR - https://nap.nationalacademies.org/catalog/25940/flourishing-in-adolescence-a-virtual-workshop-proceedings-of-a-workshop PB - The National Academies Press CY - Washington, DC LA - English KW - Behavioral and Social Sciences AB - Adolescence is a dynamic time for both brain development and social pressures, making it a critical period to understand mental, emotional, and behavioral health, yet it is often overlooked in terms of policies and service interventions, which makes many young people feel unheard when communicating their own challenges. To explore best practices in providing and supporting adolescent health services and key messaging and communication strategies related to the mental, emotional, and behavioral health of adolescents, the National Academies of Sciences, Engineering, and Medicine's Forum for Children's Well-Being held a workshop on May 5, 2020. The workshop featured a panel of youth representatives who shared their own experiences related to mental, emotional, and behavioral health. This publication summarizes the presentation and discussion of the workshop. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Eric B. Larson A2 - Clare Stroud TI - Meeting the Challenge of Caring for Persons Living with Dementia and Their Care Partners and Caregivers: A Way Forward SN - DO - 10.17226/26026 PY - 2021 UR - https://nap.nationalacademies.org/catalog/26026/meeting-the-challenge-of-caring-for-persons-living-with-dementia-and-their-care-partners-and-caregivers PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Millions of people are living with dementia in the United States and globally. To live well with dementia, people need care, services, and supports that reflect their values and preferences, build on their strengths and abilities, promote well-being, and address needs that evolve as cognitive impairment deepens. Persons living with dementia co-manage their care with or rely on the support of a wide range of care partners and caregivers, including spouses, other family members and friends, and direct care workers in homes or residential care settings. While dementia care has improved since the 1970s, many individuals still lack access to high-quality care and are not living as well as they might. Disadvantaged groups, especially racial and ethnic minorities, still face challenges in access to care, services, and supports, due to deep and persistent inequities. Meeting the Challenge of Caring for Persons Living with Dementia and Their Care Partners and Caregivers: A Way Forward examines the complex body of evidence on dementia care and informs decision making about which interventions are ready to be broadly disseminated and implemented. It also offers a blueprint to guide future research using rigorous, cutting-edge methods that are inclusive, equitable, and yield critical information for real-world implementation, toward the ultimate goal of better supporting persons living with dementia and their care partners and caregivers in living as well as possible. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine TI - Forum on Drug Discovery, Development, and Translation: 10 Year Review: 2011-2020 DO - 10.17226/26412 PY - 2021 UR - https://nap.nationalacademies.org/catalog/26412/forum-on-drug-discovery-development-and-translation-10-year-review PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - This special edition Ten-Year Review takes a look back at some of the most influential work of the National Academies' Forum on Drug Discovery, Development, and Translation over the past decade. In November 2011, amid growing concerns about the future of the U.S. clinical trials enterprise and its competitiveness on the global stage, the forum convened a public workshop for stakeholders to lay out a vision for a transformed clinical trials enterprise in the United States by 2020. This workshop laid the foundation for a variety of forum activities focused on the following thematic priorities: Innovation and the Drug R&D Enterprise Science Across the Biomedical Research Lifecycle Clinical Trials and Medical Product Development Infrastructure and Workforce Patient Engagement and Inclusivity For more information, please visit the Forum's webpage. ER - TY - BOOK AU - Institute of Medicine A2 - Sharyl J. Nass A2 - Margie Patlak TI - Contemporary Issues for Protecting Patients in Cancer Research: Workshop Summary SN - DO - 10.17226/18823 PY - 2014 UR - https://nap.nationalacademies.org/catalog/18823/contemporary-issues-for-protecting-patients-in-cancer-research-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Steve Olson TI - Moving from Evidence to Implementation of Early Childhood Programs: Proceedings of a Workshop—in Brief DO - 10.17226/23669 PY - 2016 UR - https://nap.nationalacademies.org/catalog/23669/moving-from-evidence-to-implementation-of-early-childhood-programs-proceedings PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Behavioral and Social Sciences AB - In June 2016, The National Academies of Sciences, Engineering, and Medicine held a workshop titled “Moving from Evidence to Implementation of Early Childhood Development: Strategies for Implementation.” The focus of the workshop was bringing science to practice at scale in order to bridge research to practice in local communities. Also discussed was the critical issue of the implementation of early childhood development programs. Reaching entire populations requires understanding the challenges of implementation at scale and applying the best knowledge available to ensure effective and sustainable delivery to children and their caregivers. This publication summarizes the presentations and discussions from the workshop. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Steve Olson TI - Implementing Evidence-Based Prevention by Communities to Promote Cognitive, Affective, and Behavioral Health in Children: Proceedings of a Workshop–in Brief DO - 10.17226/24762 PY - 2017 UR - https://nap.nationalacademies.org/catalog/24762/implementing-evidence-based-prevention-by-communities-to-promote-cognitive-affective-and-behavioral-health-in-children PB - The National Academies Press CY - Washington, DC LA - English KW - Behavioral and Social Sciences AB - Communities represent the front line in addressing many behavioral health conditions that children, adolescents, young adults, and their families have to face. These conditions are not rare: during their lifetimes, almost half of all Americans will meet one or more clinical criteria for behavioral health or substance abuse disorders. These disorders impose a tremendous personal burden on the affected individuals and their families, as well as substantial costs on the broader society. The first onset of such conditions is usually in childhood or adolescence, and communities can be a key opportunity for prevention, early intervention, and treatment. Given the importance of communities in shaping the health and well-being of young people, the National Academies of Sciences, Engineering, and Medicine held a workshop in June 2016, to examine the implementation of evidence-based prevention by communities. The workshop brought together researchers, program developers and implementers, state and local of officials, community leaders, health care providers, patient advocates, and other stakeholders to examine how knowledge from researchers and practitioners can best be implemented in community settings. This publication briefly summarizes the presentations and discussions from the workshop. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Erin Kellogg TI - Considerations for Using Telemental Health Services for Children and Youth: Proceedings of a Workshop–in Brief DO - 10.17226/26442 PY - 2021 UR - https://nap.nationalacademies.org/catalog/26442/considerations-for-using-telemental-health-services-for-children-and-youth PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Delivering mental services remotely did not begin during the COVID-19 pandemic, though its use has greatly expanded during this time. Looking ahead, there are questions about how those services for children and youth may continue as the pandemic recedes. To consider these questions, the National Academies of Sciences' Forum for Children's Well-Being held a 3-day workshop in October 2021 on the use of telemental health services both before and during the pandemic. This Proceedings of a Workshop-in Brief provides a high-level summary of the topics addressed in the workshop. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Emily A. Callahan TI - Engaging Communities in Addressing Structural Drivers of Obesity: Proceedings of a Workshop–in Brief DO - 10.17226/26787 PY - 2022 UR - https://nap.nationalacademies.org/catalog/26787/engaging-communities-in-addressing-structural-drivers-of-obesity-proceedings-of PB - The National Academies Press CY - Washington, DC LA - English KW - Food and Nutrition AB - Obesity is a complex disease with multiple causes and contributors that should be targeted in interventions. The Roundtable on Obesity Solutions of the National Academies of Sciences, Engineering, and Medicine convened a series of workshops on how to bridge evidence gaps within foundational drivers of obesity and translate knowledge towards actionable solutions. The second workshop in this series, Engaging Communities in Addressing Structural Drivers of Obesity, focused on community engagement in obesity solutions. It explored barriers and opportunities for community engagement and highlighted examples of community initiatives that emphasize the intersection of obesity with structural racism, bias and stigma, and health communication to address needs identified by communities and foster changes to support health and wellness. This Proceedings of a Workshop-In Brief summarizes the discussions held during the workshop. ER - TY - BOOK AU - Institute of Medicine TI - Forum on Drug Discovery, Development, and Translation: 2013 Annual Report DO - 10.17226/26114 PY - 2014 UR - https://nap.nationalacademies.org/catalog/26114/forum-on-drug-discovery-development-and-translation-2013-annual-report PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - In 2013, the National Academies’ Forum on Drug Discovery, Development, and Translation (the Forum) provided a focused venue for stakeholders to take stock of the needs and priorities in the drug discovery and development “ecosystem” and encourage meaningful information sharing and collaboration across sectors and stakeholder groups. Additionally, the Forum convened a workshop with multi-national participants from the regulatory and pharmaceutical development sectors to help foster more harmonized regulatory standards for pharmaceutical product development. The Forum membership continued its focused effort to address challenges in the U.S. clinical trials enterprise, facilitating an action-oriented, collaborative dialogue to advance development of a national accreditation system for clinical trial sites. For more information, please see https://www.nationalacademies.org/our-work/forum-on-drug-discovery-development-and-translation. ER -