TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Anne Johnson TI - Toward a Future of Environmental Health Sciences: Proceedings of a Workshop–in Brief DO - 10.17226/26639 PY - 2022 UR - https://nap.nationalacademies.org/catalog/26639/toward-a-future-of-environmental-health-sciences-proceedings-of-a PB - The National Academies Press CY - Washington, DC LA - English KW - Environment and Environmental Studies AB - What could the future of environmental health sciences hold, and what steps might be taken now to guide the field's trajectory? To envision a future research enterprise that integrates environmental health sciences, biomedical science, prevention research, and disease-specific research across the continuum from fundamental discovery research through the application of this research to population health, the National Academies of Sciences, Engineering, and Medicine hosted a workshop titled Towards a Future of Environmental Health Sciences on April 26-27, 2022. This publication summarizes the presentations and discussion of the workshop. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Sarah Carter A2 - Eva Childers A2 - Sheena M. Posey Norris TI - Multimodal Biomarkers for Central Nervous System Disorders: Development, Validation, and Clinical Integration: Proceedings of a Workshop SN - DO - 10.17226/27208 PY - 2023 UR - https://nap.nationalacademies.org/catalog/27208/multimodal-biomarkers-for-central-nervous-system-disorders-development-validation-and PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - A key step towards reducing the burden of central nervous system (CNS) disorders is the identification of disease-specific biomarkers that can help predict, monitor, and guide treatment development. Recent technological advances have led to an increased number of biomarkers for different CNS disorders, providing the opportunity to generate multimodal biomarkers. While multimodal biomarkers can serve as promising tools to better diagnose and make accurate disease assessments, there remain challenges in current data collection, standardization, and validation practices that impede in their development. Recognizing the need for increased CNS biomarker integration, the National Academies Forum on Neuroscience and Nervous System Disorders hosted a public workshop in March 2023 to explore steps toward this goal, including data collection for biomarker discovery, development, validation, and assessment of clinical utility. This Proceedings of a Workshop summarizes the discussions held during the workshop. ER - TY - BOOK AU - Institute of Medicine AU - National Academies of Sciences, Engineering, and Medicine TI - Ovarian Cancers: Evolving Paradigms in Research and Care SN - DO - 10.17226/21841 PY - 2016 UR - https://nap.nationalacademies.org/catalog/21841/ovarian-cancers-evolving-paradigms-in-research-and-care PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Biology and Life Sciences AB - In an era of promising advances in cancer research, there are considerable and even alarming gaps in the fundamental knowledge and understanding of ovarian cancer. Researchers now know that ovarian cancer is not a single disease—several distinct subtypes exist with different origins, risk factors, genetic mutations, biological behaviors, and prognoses. However, persistent questions have impeded progress toward improving the prevention, early detection, treatment, and management of ovarian cancers. Failure to significantly improve morbidity and mortality during the past several decades is likely due to several factors, including the lack of research being performed by specific disease subtype, lack of definitive knowledge of the cell of origin and disease progression, and incomplete understanding of genetic and non-genetic risk factors. Ovarian Cancers examines the state of the science in ovarian cancer research, identifies key gaps in the evidence base and the challenges to addressing those gaps, considers opportunities for advancing ovarian cancer research, and examines avenues for translation and dissemination of new findings and communication of new information to patients and others. This study makes recommendations for public- and private-sector efforts that could facilitate progress in reducing the incidence of morbidity and mortality from ovarian cancers. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - David A. Savitz A2 - Anne N. Styka TI - Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis SN - DO - 10.17226/25688 PY - 2020 UR - https://nap.nationalacademies.org/catalog/25688/assessment-of-long-term-health-effects-of-antimalarial-drugs-when-used-for-prophylaxis PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events. ER - TY - BOOK AU - National Research Council A2 - Jeffrey Fox A2 - Marilee Shelton-Davenport A2 - India Hook-Barnard TI - Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches: Summary of a Workshop SN - DO - 10.17226/12899 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12899/considerations-for-ensuring-safety-and-efficacy-of-vaccines-and-therapeutic-proteins-manufactured-by-using-platform-approaches PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - A major goal of the US Department of Defense (DOD) Transformational Medical Technologies Initiative (TMTI) is to develop countermeasures that will protect military personnel against bioweapons, including specific infectious-disease agents and toxins. An explicit TMTI objective is to respond quickly to such threats by producing an appropriate amount of an effective countermeasure--currently defined as enough material to treat or vaccinate 3 million personnel--within 12 months of identification of a specific threat. DOD officials call for TMTI programs to be up and running by 2014. The National Academies hosted a workshop which brought together scientists from academe, government, and the biotechnology industry to identify and discuss challenges and ideas related to the TMTI's vision of developing countermeasures within a few months after an agent is identified. The workshop focused on manufacturing processes and specifically on the development of "manufacturing platforms"--repeatable components of manufacturing that reduce both development time and risk. An underlying assumption was that demonstrating that integrated platforms can reliably produce safe and efficacious countermeasures might shorten the regulatory approval process. The workshop is summarized in this book. ER - TY - BOOK AU - Institute of Medicine A2 - Adam C. Berger A2 - Steve Olson TI - Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary SN - DO - 10.17226/18275 PY - 2013 UR - https://nap.nationalacademies.org/catalog/18275/genome-based-diagnostics-demonstrating-clinical-utility-in-oncology-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology is the summary of a workshop convened in May 2012 by the Roundtable on Translating Genomic-Based Research for Health and the Center for Medical Technology Policy of the Institute of Medicine to foster the identified need for further sustained dialogue between stakeholders regarding the clinical utility of molecular diagnostics. The workshop brought together a wide range of stakeholders, including patients, health care providers, policy makers, payers, diagnostic test developers, researchers, and guideline developers, to identify the challenges and opportunities in advancing the development and use of molecular diagnostic tests designed to guide the treatment and management of patients with cancer. The sequencing of the human genome has greatly accelerated the process of linking specific genetic variants with disease. These findings have yielded a rapidly increasing number of molecular diagnostic tests designed to guide disease treatment and management. Many of these tests are aimed at determining the best treatments for specific forms of cancer, making oncology a valuable testing ground for the use of molecular diagnostic tests in medicine in general. Nevertheless, many questions surround the clinical value of molecular diagnostic tests, and their acceptance by clinicians, payers, and patients has been unpredictable. A major limiting factor for the use of these tests has been the lack of clear evidence of clinical utility. Genome-Based Diagnostics assesses the evidentiary requirements for clinical utility of molecular diagnostics used to guide treatment decisions for patients with cancer; discusses methodologies related to demonstrating these evidentiary requirements that meet the needs of all stakeholders; and considers innovative, sustainable research collaborations for generating evidence of clinical utility involving multiple stakeholders. ER - TY - BOOK AU - Institute of Medicine TI - Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the National Institutes of Health SN - DO - 10.17226/6225 PY - 1998 UR - https://nap.nationalacademies.org/catalog/6225/scientific-opportunities-and-public-needs-improving-priority-setting-and-public PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The National Institutes of Health (NIH) is the single largest funder of health research in the United States, and research it has supported has been pivotal to the explosion of biomedical knowledge over the past century. As NIH's success has grown, so has pressure from advocacy groups and other members of the public to devote more spending to their health concerns. In response to a request from Congress, this IOM study reviewed NIH's research priority-setting process and made recommendations for possible improvement. The committee considered the: Factors and criteria used by NIH to make funding allocations. Process by which the funding decisions are made. Mechanisms for public input. Impact of congressional statutory directives on funding decisions. Among other recommendations, the book recommends that NIH seek broader public input on decisions about how to spend its nearly $14 billion budget; it also urged the agency to create new Offices of Public Liaison in the Office of the Director and in each of the 21 research institutes to allow interested people to formally take part in the process. ER - TY - BOOK AU - National Academy of Sciences A2 - Esther Landhuis TI - From Research to Reward: How Lab Experiments with T Cells Brought a New Wave of Cancer Therapies DO - 10.17226/25517 PY - 2019 UR - https://nap.nationalacademies.org/catalog/25517/from-research-to-reward-how-lab-experiments-with-t-cells PB - The National Academies Press CY - Washington, DC LA - English ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine TI - Rapid Expert Consultation on Self-Tests for Infectious Diseases: Lessons Learned from COVID-19 DO - 10.17226/26694 PY - 2022 UR - https://nap.nationalacademies.org/catalog/26694/rapid-expert-consultation-on-self-tests-for-infectious-diseases-lessons PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The pandemic self-testing experience has shown some great successes, which are a tribute to the hard work of individuals at all stages in the development, manufacture, regulation, distribution, and uptake processes. However, it has also demonstrated notable challenges, many arising from the lack of a proactive and comprehensive strategy, with the feedback and flexibility needed for adaptive management as the disease, diagnostic tests, and public opinion evolved. This rapid expert consultation summarizes the lessons learned from the COVID-19 pandemic for the future development and usage of self-tests for circulating infectious diseases and future outbreaks and pandemics. It draws from expert input and published research from previous public health emergencies, as well as the ongoing COVID-19 pandemic. This rapid expert consultation was produced through the Standing Committee for CDC Center for Preparedness and Response (SCPR), an activity of the Health and Medicine Division of National Academies of Sciences, Engineering, and Medicine, sponsored by the Centers for Disease Control and Prevention. SCPR provides a forum for discussion of scientific, technical, and social issues relevant to public health emergency preparedness and response.” ER - TY - BOOK AU - Institute of Medicine TI - Forum on Neuroscience and Nervous System Disorders: 2011 Annual Report DO - 10.17226/26235 PY - 2012 UR - https://nap.nationalacademies.org/catalog/26235/forum-on-neuroscience-and-nervous-system-disorders-2011-annual-report PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine ER - TY - BOOK AU - National Research Council AU - National Research Council TI - Science, Medicine, and Animals: A Circle of Discovery: Teacher's Guide SN - DO - 10.17226/11564 PY - 2005 UR - https://nap.nationalacademies.org/catalog/11564/science-medicine-and-animals-a-circle-of-discovery-teachers-guide PB - The National Academies Press CY - Washington, DC LA - English KW - Biology and Life Sciences KW - Education AB - Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher’s Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher’s Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher’s Guide was reviewed by members of the National Academies’ Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher’s Association NSTA Recommends. ER - TY - BOOK AU - Institute of Medicine TI - Effectiveness and Outcomes in Health Care: Proceedings of an Invitational Conference SN - DO - 10.17226/1631 PY - 1990 UR - https://nap.nationalacademies.org/catalog/1631/effectiveness-and-outcomes-in-health-care-proceedings-of-an-invitational PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine ER - TY - BOOK AU - Transportation Research Board AU - National Academies of Sciences, Engineering, and Medicine TI - A Guide to Traffic Control of Rural Roads in an Agricultural Emergency DO - 10.17226/14184 PY - 2008 UR - https://nap.nationalacademies.org/catalog/14184/a-guide-to-traffic-control-of-rural-roads-in-an-agricultural-emergency PB - The National Academies Press CY - Washington, DC LA - English KW - Transportation and Infrastructure AB - TRB’s National Cooperative Highway Research Program (NCHRP) Report 525: Surface Transportation Security, Volume 13: A Guide to Traffic Control of Rural Roads in an Agricultural Emergency explores recommended practices and procedures associated with traffic control on local and state roads during agricultural emergencies. The report examines three levels of traffic control based on the type of disease and location of the traffic control point. In the development of the NCHRP Report 525, Vol. 13, an annotated bibliography was prepared that reviews several state emergency response plans. This bibliography was published as NCHRP Web-Only Document 130.NCHRP Report 525: Surface Transportation Security is a series in which relevant information is assembled into single, concise volumes—each pertaining to a specific security problem and closely related issues. The volumes focus on the concerns that transportation agencies are addressing when developing programs in response to the terrorist attacks of September 11, 2001, and the anthrax attacks that followed. Future volumes of the report will be issued as they are completed.A PowerPoint presentation describing the project is available online. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Anne Brown Rodgers TI - Examining Special Nutritional Requirements in Disease States: Proceedings of a Workshop SN - DO - 10.17226/25164 PY - 2018 UR - https://nap.nationalacademies.org/catalog/25164/examining-special-nutritional-requirements-in-disease-states-proceedings-of-a PB - The National Academies Press CY - Washington, DC LA - English KW - Food and Nutrition KW - Health and Medicine AB - The amount of nutrients required by an individual is determined by a number of physiological processes, including absorption, metabolism, stability, and bio-activation. These processes determine nutrient needs and provide variations in requirements in the population. All have modifiers and sensitizers, such as sex, genetics, pregnancy, age, pharmaceuticals, toxins, food matrix, and epigenetics. Disease can also be a major modifier of these processes. In April 2018, the National Academies of Science, Engineering and Medicine convened a workshop in order to explore the evidence for special nutritional requirements in disease states and the medical conditions that cannot be met with a normal diet. Participants explored the impact a disease state can have on nutrient metabolism and nutritional status, and attempted to close informational gaps. This publication summarizes the presentations and discussions from the workshop. ER - TY - BOOK AU - Institute of Medicine AU - National Academy of Engineering A2 - Guruprasad Madhavan A2 - Charles Phelps A2 - Rino Rappuoli A2 - Rose Marie Martinez A2 - Lonnie King TI - Ranking Vaccines: Applications of a Prioritization Software Tool: Phase III: Use Case Studies and Data Framework SN - DO - 10.17226/18763 PY - 2015 UR - https://nap.nationalacademies.org/catalog/18763/ranking-vaccines-applications-of-a-prioritization-software-tool-phase-iii PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - SMART Vaccines - Strategic Multi-Attribute Ranking Tool for Vaccines - is a prioritization software tool developed by the Institute of Medicine that utilizes decision science and modeling to help inform choices among candidates for new vaccine development. A blueprint for this computer-based guide was presented in the 2012 report Ranking Vaccines: A Prioritization Framework: Phase I. The 2013 Phase II report refined a beta version of the model developed in the Phase I report. Ranking Vaccines: Applications of a Prioritization Software Tool: Phase III: Use Case Studies and Data Framework extends this project by demonstrating the practical applications of SMART Vaccines through use case scenarios in partnership with the Public Health Agency of Canada, New York State Department of Health, and the Serum Institute of India. This report also explores a novel application of SMART Vaccines in determining new vaccine product profiles, and offers practical strategies for data synthesis and estimation to encourage the broader use of the software. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine TI - Harnessing Innovative Biotechnologies for National Security in Material and Human Dimensions: Abridged Version DO - 10.17226/27023 PY - 2023 UR - https://nap.nationalacademies.org/catalog/27023/harnessing-innovative-biotechnologies-for-national-security-in-material-and-human-dimensions PB - The National Academies Press CY - Washington, DC LA - English KW - Biology and Life Sciences KW - Conflict and Security Issues AB - This publication is the unclassified summary of a classified consensus report linking advanced biotechnologies to national security capability needs and identifying potential pathways for their adoption. ER - TY - BOOK AU - Institute of Medicine A2 - Adam C. Berger A2 - Samuel G. Johnson A2 - Sarah H. Beachy A2 - Steve Olson TI - Improving Genetics Education in Graduate and Continuing Health Professional Education: Workshop Summary SN - DO - 10.17226/18992 PY - 2015 UR - https://nap.nationalacademies.org/catalog/18992/improving-genetics-education-in-graduate-and-continuing-health-professional-education PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Education AB - Many health care providers do not have either the knowledge or the tools they need in order to apply genetic information in their day-to-day practices. This lack of support is contributing to a substantial delay in the translation of genetic research findings, when appropriate, into improvement in patient outcomes within the health care system. Although the need to improve genetics knowledge among health care providers is clear, the best approaches to educating health care providers in a way that produces meaningful changes in clinical practice are not, especially given the competing coursework and training needs that exist in today's increasingly complex health care settings. To examine the potential and the challenges of providing genetics education, the Roundtable on Translating Genomic-Based Research for Health of the Institute of Medicine hosted a workshop on August 18, 2014. The workshop examined a variety of approaches that could improve the teaching of genetics in the graduate and continuing education of health professionals; these approaches included online and interactive instruction, just-in-time approaches, the development of clinical decision-support tools, and the incorporation of genetics requirements into licensing and accreditation. This report summarizes the presentations and discussion of the event. ER - TY - BOOK AU - National Research Council TI - Radiation Dose Reconstruction for Epidemiologic Uses SN - DO - 10.17226/4760 PY - 1995 UR - https://nap.nationalacademies.org/catalog/4760/radiation-dose-reconstruction-for-epidemiologic-uses PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Environment and Environmental Studies AB - Growing public concern about releases of radiation into the environment has focused attention on the measurement of exposure of people living near nuclear weapons production facilities or in areas affected by accidental releases of radiation. Radiation-Dose Reconstruction for Epidemiologic Uses responds to the need for criteria for dose reconstruction studies, particularly if the doses are to be useful in epidemiology. This book provides specific and practical recommendations for whether, when, and how studies should be conducted, with an emphasis on public participation. Based on the expertise of scientists involved in dozens of dose reconstruction projects, this volume: Provides an overview of the basic requirements and technical aspects of dose reconstruction. Presents lessons to be learned from dose reconstructions after Chernobyl, Three Mile Island, and elsewhere. Explores the potential benefits and limitations of biological markers. Discusses how to establish the "source term"—that is, to determine what was released. Explores methods for identifying the environmental pathways by which radiation reaches the body. Offers details on three major categories of dose assessment. ER - TY - BOOK AU - National Research Council TI - Accounting for Health and Health Care: Approaches to Measuring the Sources and Costs of Their Improvement SN - DO - 10.17226/12938 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12938/accounting-for-health-and-health-care-approaches-to-measuring-the PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Behavioral and Social Sciences KW - Surveys and Statistics AB - It has become trite to observe that increases in health care costs have become unsustainable. How best for policy to address these increases, however, depends in part on the degree to which they represent increases in the real quantity of medical services as opposed to increased unit prices of existing services. And an even more fundamental question is the degree to which the increased spending actually has purchased improved health. Accounting for Health and Health Care addresses both these issues. The government agencies responsible for measuring unit prices for medical services have taken steps in recent years that have greatly improved the accuracy of those measures. Nonetheless, this book has several recommendations aimed at further improving the price indices. ER - TY - BOOK AU - Institute of Medicine AU - National Research Council A2 - Bruce M. Altevogt A2 - Diana E. Pankevich A2 - Marilee K. Shelton-Davenport A2 - Jeffrey P. Kahn TI - Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity SN - DO - 10.17226/13257 PY - 2011 UR - https://nap.nationalacademies.org/catalog/13257/chimpanzees-in-biomedical-and-behavioral-research-assessing-the-necessity PB - The National Academies Press CY - Washington, DC LA - English KW - Biology and Life Sciences KW - Health and Medicine KW - Agriculture AB - For many years, experiments using chimpanzees have been instrumental in advancing scientific knowledge and have led to new medicines to prevent life-threatening and debilitating diseases. However, recent advances in alternate research tools have rendered chimpanzees largely unnecessary as research subjects. The Institute of Medicine, in collaboration with the National Research Council, conducted an in-depth analysis of the scientific necessity for chimpanzees in NIH-funded biomedical and behavioral research. The committee concludes that while the chimpanzee has been a valuable animal model in the past, most current biomedical research use of chimpanzees is not necessary, though noted that it is impossible to predict whether research on emerging or new diseases may necessitate chimpanzees in the future. ER -