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"A consensus study report of the National Academies of Sciences, Engineering, Medicine."

"Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of efforts--by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)--to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop"--

"Millions of people--infants, children, adults, and their families--are currently coping with serious illness in the United States. Efforts are intensifying to improve overall care quality through the delivery of person-centered and family-oriented services, for patients of all ages and across disease stages, care settings, and specialties. While aging Baby Boomers are increasing the proportion of patients in the Medicare population over time, the sickest and most vulnerable patients needing health system support and other services to meet their complex needs can be found across the age spectrum and in a broad range of care settings, from perinatal care to geriatric care. Recognizing the need to thoughtfully consider and address the challenges and opportunities in efforts to improve care quality and value, the Roundtable on Quality Care for People with Serious Illness of the National Academies of Sciences, Engineering, and Medicine held the public workshop Integrating the Patient and Caregiver Voice into Serious Illness Care, on December 15, 2016, in Washington, DC. This workshop was the first in a series planned by the roundtable, and was designed specifically to bring together diverse personal perspectives and experiences about priorities and values that are important to patients and families coping with serious illness, and to consider solutions that support integration of these priorities and values in practice. This publication summarizes the presentations and discussions from the workshop"--

"Appendixes B-F are not printed in this publication. They are available online at https://www.nap.edu/catalog/24758" --page 16

Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. Novel clinical trial designs that enroll participants based on their genetics represent a potentially disruptive change that could improve patient outcomes, reduce costs associated with drug development, and further realize the goals of precision medicine. On March 8, 2017, the Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine hosted the workshop Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development. Participants examined successes, challenges, and possible best practices for effectively using genetic information in the design and implementation of clinical trials to support the development of precision medicines, including exploring the potential advantages and disadvantages of such trials across a variety of disease areas. This publication summarizes the presentations and discussions from the workshop.

"This proceedings summarizes the presentations and discussions at the 1-day public workshop on Principles and Practices for Federal Program Evaluation, which was in held Washington, DC. in October 2016"--Page 1.

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

"A consensus study report of The National Academies of Sciences, Engineering, and Medicine."

In September 2015, the Sustainable Development Goals (SDGs) were adopted at the United Nations Development Summit to serve as a 15-year plan of action for all countries and people. The SDGs include 17 specific goals, and 169 associated targets that set out quantitative objectives across the social, economic, and environmental dimensions of sustainable development, all to be achieved by 2030. Health has been recognized as crucial for sustainable human development and an essential contributor to the economic growth of society. Beyond the goal to "ensure healthy lives and promoting well-being for all at all ages," many of the other SDGs include targets that are essential to address the environmental and social determinants of health. Considering this context, the Forum on Public-Private Partnerships for Global Health and Safety convened a workshop series to examine potential opportunities to engage the private sector and develop partnerships to advance health and the SDGs. This publication summarizes the presentations and discussions from the workshop series.

In 2015, the National Academies of Sciences, Engineering, and Medicine convened two workshops with oversight from the Committee on the Science of Changing Behavioral Health Social Norms. The workshops provided input to the committee's deliberations and contributed to the development of the report Ending Discrimination against People with Mental and Substance Use Disorders. That report was issued to help the Substance Abuse and Mental Health Services Administration and the Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, utilize the scientific evidence base in improving public attitudes toward and understanding of behavioral health, specifically in the areas of mental health and substance use disorders. This publication summarizes the presentations and discussions at the two workshops.

Introduction -- Overview, evaluations, and criticisms of the safety measurement system -- Applications of item response theory models in other contexts and public release and transparency -- Applying item response theory models to highway safety -- Extensions of and implementation of the item response theory model to the safety measurement system -- Data availability and quality.

"A Consensus Study Report of The National Academies of Sciences, Engineering, Medicine."

"Societies around the world are concerned about dementia and the other forms of cognitive impairment that affect many older adults. We now know that brain changes typically begin years before people show symptoms, which suggests a window of opportunity to prevent or delay the onset of these conditions. Emerging evidence that the prevalence of dementia is declining in high-income countries offers hope that public health interventions will be effective in preventing or delaying cognitive impairments. Until recently, the research and clinical communities have focused primarily on understanding and treating these conditions after they have developed. Thus, the evidence base on how to prevent or delay these conditions has been limited at best, despite the many claims of success made in popular media and advertising. Today, however, a growing body of prevention research is emerging. Preventing Cognitive Decline and Dementia: A Way Forward assesses the current state of knowledge on interventions to prevent cognitive decline and dementia, and informs future research in this area. This report provides recommendations of appropriate content for inclusion in public health messages from the National Institute on Aging"--

Building on previous National Academies of Sciences, Engineering, and Medicine workshops that explored how safe and healthy communities are a necessary component of health equity and efforts to improve population health, the Roundtable on Population Health Improvement wanted to explore how a variety of community-based organizations came together to achieve population health. To do so, the roundtable hosted a workshop in Oakland, California, on December 8, 2016, to explore multisector health partnerships that engage residents, reduce health disparities, and improve health and well-being. This publication summarizes the presentations and discussions from the workshop.

"Building communication capacity is a critical piece of preparing for, detecting, and responding to infectious disease threats. The International Health Regulations (IHR) establish risk communication--the real-time exchange of information, advice, and opinions between experts or officials and people who face a threat to their survival, health, and economic or social well-being--as a core capacity that World Health Organization member states must fulfill to strengthen the fight against these threats. Despite global recognition of the importance of complying with IHR, 67 percent of signatory countries report themselves as not compliant. By investing in communication capacity, public health and government officials and civil society organizations facing health crises would be prepared to provide advice, information, and reassurance to the public as well as to rapidly develop messages and community engagement activities that are coordinated and take into account social and behavioral dynamics among all sectors. To learn about current national and international efforts to develop the capacity to communicate effectively during times of infectious disease outbreaks, and to explore gaps in the research agenda that may help address communication needs to advance the field, the Forum on Microbial Threats of the National Academies of Sciences, Engineering, and Medicine convened a 1.5 day workshop on December 13 and 14, 2016, in Washington, DC. Participants reviewed progress and needs in strengthening communication capacity for dealing with infectious disease threats for both outbreaks and routine challenges in the United States and abroad. This publication summarizes the presentations and discussions from the workshop"--

Environmental research has driven landmark improvements that led to the protection of human and ecosystem health. Recognizing the value of knowledge generated by environmental research and the ingenuity within academic and nonprofit institutions, the US Environmental Protection Agency (EPA) created a program known as Science to Achieve Results, or STAR, in 1995. STAR is EPA's primary competitive extramural grants program. A Review of the Environmental Protection Agency's Science to Achieve Results Research Program assesses the program's scientific merit, public benefits, and overall contributions in the context of other relevant research and recommends ways to enhance those aspects of the program. This report also considers the conclusions and recommendations of a prior National Research Council review of the STAR program (2003), the STAR program's research priorities in light of the nation's environmental challenges, and the effects of recent STAR funding trends on obtaining scientific information needed to protect public health and the environment.

After decades of increases in the obesity rate among U.S. adults and children, the rate recently has dropped among some populations, particularly young children. What are the factors responsible for these changes? How can promising trends be accelerated? What else needs to be known to end the epidemic of obesity in the United States? To examine these and other pressing questions, the Roundtable on Obesity Solutions, of the National Academies of Sciences, Engineering, and Medicine, held a workshop in September 2016. The workshop brought together leaders from business, early care and education, government, health care, and philanthropy to discuss the most promising approaches for the future of obesity prevention and treatment. This publication summarizes the presentations and discussions from the workshop.

"Brucellosis is a nationally and internationally regulated disease of livestock with significant consequences for animal health, public health, and international trade. In cattle, the primary cause of brucellosis is Brucella abortus, a zoonotic bacterial pathogen that also affects wildlife, including bison and elk. As a result of the Brucellosis Eradication Program that began in 1934, most of the country is now free of bovine brucellosis. The Greater Yellowstone Area (GYA), where brucellosis is endemic in bison and elk, is the last known B. abortus reservoir in the United States. The GYA is home to more than 5,500 bison that are the genetic descendants of the original free-ranging bison herds that survived in the early 1900s, and home to more than 125,000 elk whose habitats are managed through interagency efforts, including the National Elk Refuge and 22 supplemental winter feedgrounds maintained in Wyoming." --

"A consensus study report of The National Academies of Sciences, Engineering, Medicine."

"Though cancer was once considered to be a problem primarily in wealthy nations, low- and middle-income countries now bear a majority share of the global cancer burden, and cancer often surpasses the burden of infectious diseases in these countries. Effective low-cost cancer control options are available for some malignancies, with the World Health Organization estimating that these interventions could facilitate the prevention of approximately one-third of cancer deaths worldwide. Effective cancer treatment approaches are also available and can reduce the morbidity and mortality due to cancer in low-resource areas. But these interventions remain inaccessible for many people in the world, especially those residing in low-resource communities that are characterized by a lack of funds--on an individual or a societal basis--to cover health infrastructure and care costs. As a result, worse outcomes for patients with cancer are more common in low- and middle-income countries compared with high-income countries. Few guidelines and strategies for cancer control consider the appropriateness and feasibility of interventions in low-resource settings, and this may undermine the effectiveness of care. Recognizing the challenges of providing cancer care in resource constrained settings, the National Academies of Sciences, Engineering, and Medicine developed a two- workshop series examining cancer care in low-resource communities, building on prior work of the National Academies. The first workshop, held in October 2015, focused on cancer prevention and early detection. The second workshop was held in November 2016, and focused on cancer treatment, palliative care, and survivorship care in low-resource areas. This publication summarizes the presentations and discussions of this workshop"--

Accessible and affordable housing can enable community living, maximize independence, and promote health for vulnerable populations. However, the United States faces a shortage of affordable and accessible housing for low-income older adults and individuals living with disabilities. This shortage is expected to grow over the coming years given the population shifts leading to greater numbers of older adults and of individuals living with disabilities. Housing is a social determinant of health and has direct effects on health outcomes, but this relationship has not been thoroughly investigated. In December 2016, the National Academies of Sciences, Engineering, and Medicine convened a public workshop to better understand the importance of affordable and accessible housing for older adults and people with disabilities, the barriers to providing this housing, the design principles for making housing accessible for these individuals, and the features of programs and policies that successfully provide affordable and accessible housing that supports community living for older adults and people with disabilities. This publication summarizes the presentations and discussions from the workshop.

"In the coming years, complex domestic and international environments and challenges to national security will continue. Intelligence analysts and the intelligence community will need access to the appropriate tools and developing knowledge about threats to national security in order to provide the best information to policy makers. Research and knowledge from the social and behavioral sciences (SBS) can help inform the work of intelligence analysis; however, in the past, bringing important findings from research to bear on the day-to-day work of intelligence analysis has been difficult. In order to understand how knowledge from science can be directed and applied to help the intelligence community fulfill its critical responsibilities, the National Academies of Sciences, Engineering, and Medicine will undertake a 2-year survey of the social and behavioral sciences. To launch this discussion, a summit designed to highlight cutting-edge research and identify future directions for research in a few areas of the social and behavioral sciences was held in October 2016. This publication summarizes the presentations and discussions from the summit"--Publisher's description.

"In September 2016, the National Academies of Sciences, Engineering, and Medicine convened a workshop to examine trends and patterns in aging and factors related to healthy aging in the United States, with a focus on nutrition, and how nutrition can sustain and promote healthy aging, not just in late adulthood, but beginning in pregnancy and early childhood and extending throughout the lifespan. Participants discussed the role of nutrition in the aging process at various stages in life, changes in organ systems over the lifespan and changes that occur with age related to cognitive, brain, and mental health, and explored opportunities to move forward in promoting healthy aging in the United States. This publication summarizes the presentations and discussions from the workshop"--

"While much progress has been made on achieving the Millennium Development Goals over the last decade, the number and complexity of global health challenges has persisted. Growing forces for globalization have increased the interconnectedness of the world and our interdependency on other countries, economies, and cultures. Monumental growth in international travel and trade have brought improved access to goods and services for many, but also carry ongoing and ever-present threats of zoonotic spillover and infectious disease outbreaks that threaten all. Global Health and the Future Role of the United States identifies global health priorities in light of current and emerging world threats. This report assesses the current global health landscape and how challenges, actions, and players have evolved over the last decade across a wide range of issues, and provides recommendations on how to increase responsiveness, coordination, and efficiency - both within the U.S. government and across the global health field."--

"A report of the National Academies of Sciences, Engineering, Medicine."

The U.S. Census Bureau has reported that 56.7 million Americans had some type of disability in 2010, which represents 18.7 percent of the civilian noninstitutionalized population included in the 2010 Survey of Income and Program Participation. The U.S. Social Security Administration (SSA) provides disability benefits through the Social Security Disability Insurance (SSDI) program and the Supplemental Security Income (SSI) program. As of December 2015, approximately 11 million individuals were SSDI beneficiaries, and about 8 million were SSI beneficiaries. SSA currently considers assistive devices in the nonmedical and medical areas of its program guidelines. During determinations of substantial gainful activity and income eligibility for SSI benefits, the reasonable cost of items, devices, or services applicants need to enable them to work with their impairment is subtracted from eligible earnings, even if those items or services are used for activities of daily living in addition to work. In addition, SSA considers assistive devices in its medical disability determination process and assessment of work capacity. The Promise of Assistive Technology to Enhance Activity and Work Participation provides an analysis of selected assistive products and technologies, including wheeled and seated mobility devices, upper-extremity prostheses, and products and technologies selected by the committee that pertain to hearing and to communication and speech in adults.

The future security, economic growth, and competitiveness of the United States depend on its capacity to innovate. Major sources of innovative capacity are the new knowledge and trained students generated by U.S. research universities. However, many of the complex technical and societal problems the United States faces cannot be addressed by the traditional model of individual university research groups headed by a single principal investigator. Instead, they can only be solved if researchers from multiple institutions and with diverse expertise combine their efforts. The National Science Foundation (NSF), among other federal agencies, began to explore the potential of such center-scale research programs in the 1970s and 1980s; in many ways, the NSF Engineering Research Center (ERC) program is its flagship program in this regard. The ERCs are "interdisciplinary, multi-institutional centers that join academia, industry, and government in partnership to produce transformational engineered systems and engineering graduates who are adept at innovation and primed for leadership in the global economy. To ensure that the ERCs continue to be a source of innovation, economic development, and educational excellence, A New Vision for Center-Based Engineering Research explores the future of center-based engineering research, the skills needed for effective center leadership, and opportunities to enhance engineering education through the centers.

"A Consensus Study Report of The National Academies of Sciences, Engineering, Medicine."

"A report of the National Academies of Sciences, Engineering, Medicine."