TY - BOOK AU - Institute of Medicine A2 - Margie Patlak A2 - Laura Levit TI - Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary SN - DO - 10.17226/12779 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12779/policy-issues-in-the-development-of-personalized-medicine-in-oncology PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Biology and Life Sciences AB - One of the challenges in treating cancer is the disease's complexity and variation among patients. Cancer manifests differently in each patient, so treatments that are effective in one patient may not be effective in another. As cancer care becomes more personalized, subpopulations of individuals will be given preventive or therapeutic interventions based on their susceptibility to a particular disease or their predicted response to a specific treatment. However, before the use of personalized cancer care can reach its full potential, the health care system must resolve a number of technological, regulatory, and reimbursement issues. To explore these policy challenges, the National Cancer Policy Forum held the workshop Policy Issues in the Development of Personalized Medicine in Oncology in June 2009. Experts provided presentations on the current state of personalized medicine technology, as well as issues in the validation of, regulation of, and reimbursement for the predictive tests that underpin personalized medicine. Participants discussed the obstacles and possible solutions to further developing and using personalized medicine technologies. This document summarizes the workshop. ER - TY - BOOK TI - Organic Matrix Structural Composites: Quality Assurance and Reproducibility DO - 10.17226/19735 PY - 1981 UR - https://nap.nationalacademies.org/catalog/19735/organic-matrix-structural-composites-quality-assurance-and-reproducibility PB - The National Academies Press CY - Washington, DC LA - English KW - KW - Engineering and Technology ER - TY - BOOK AU - Institute of Medicine A2 - Lori B. Andrews A2 - Jane E. Fullarton A2 - Neil A. Holtzman A2 - Arno G. Motulsky TI - Assessing Genetic Risks: Implications for Health and Social Policy SN - DO - 10.17226/2057 PY - 1994 UR - https://nap.nationalacademies.org/catalog/2057/assessing-genetic-risks-implications-for-health-and-social-policy PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings. ER - TY - BOOK AU - Institute of Medicine A2 - Margie Patlak A2 - Sharyl Nass TI - Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics: Workshop Summary SN - DO - 10.17226/11768 PY - 2006 UR - https://nap.nationalacademies.org/catalog/11768/developing-biomarker-based-tools-for-cancer-screening-diagnosis-and-treatment PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Research has long sought to identify biomarkers that could detect cancer at an early stage, or predict the optimal cancer therapy for specific patients. Fueling interest in this research are recent technological advances in genomics, proteomics, and metabolomics that can enable researchers to capture the molecular fingerprints of specific cancers and fine-tune their classification according to the molecular defects they harbor. The discovery and development of new markers of cancer could potentially improve cancer screening, diagnosis, and treatment. Given the potential impact cancer biomarkers could have on the cost effectiveness of cancer detection and treatment, they could profoundly alter the economic burden of cancer as well. Despite the promise of cancer biomarkers, few biomarker-based cancer tests have entered the market, and the translation of research findings on cancer biomarkers into clinically useful tests seems to be lagging. This is perhaps not surprising given the technical, financial, regulatory, and social challenges linked to the discovery, development, validation, and incorporation of biomarker tests into clinical practice. To explore those challenges and ways to overcome them, the National Cancer Policy Forum held the conference "Developing Biomarker-Based Tools for Cancer Screening, Diagnosis and Treatment: The State of the Science, Evaluation, Implementation, and Economics" in Washington, D.C., from March 20 to 22, 2006. At this conference, experts gave presentations in one of six sessions. In addition, seven small group discussions explored the policy implications surrounding biomarker development and adoption into clinical practice. Developing Biomarker-based Tools for Developing Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics-Workshop Summary presents the conference proceedings and will be used by an Institute of Medicine (IOM) committee to develop consensus-based recommendations for moving the field of cancer biomarkers forward. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine TI - An Evidence Framework for Genetic Testing SN - DO - 10.17226/24632 PY - 2017 UR - https://nap.nationalacademies.org/catalog/24632/an-evidence-framework-for-genetic-testing PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Advances in genetics and genomics are transforming medical practice, resulting in a dramatic growth of genetic testing in the health care system. The rapid development of new technologies, however, has also brought challenges, including the need for rigorous evaluation of the validity and utility of genetic tests, questions regarding the best ways to incorporate them into medical practice, and how to weigh their cost against potential short- and long-term benefits. As the availability of genetic tests increases so do concerns about the achievement of meaningful improvements in clinical outcomes, costs of testing, and the potential for accentuating medical care inequality. Given the rapid pace in the development of genetic tests and new testing technologies, An Evidence Framework for Genetic Testing seeks to advance the development of an adequate evidence base for genetic tests to improve patient care and treatment. Additionally, this report recommends a framework for decision-making regarding the use of genetic tests in clinical care. ER - TY - BOOK AU - Institute of Medicine AU - National Academies of Sciences, Engineering, and Medicine TI - Roundtable on Translating Genomic-Based Research for Health: 2010 Annual Report DO - 10.17226/26249 PY - 2011 UR - https://nap.nationalacademies.org/catalog/26249/roundtable-on-translating-genomic-based-research-for-health-2010-annual PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine ER - TY - BOOK AU - National Research Council TI - Quantitative Relationship Between Mutagenic and Carcinogenic Potencies: A Feasibility Study SN - DO - 10.17226/747 PY - 1983 UR - https://nap.nationalacademies.org/catalog/747/quantitative-relationship-between-mutagenic-and-carcinogenic-potencies-a-feasibility-study PB - The National Academies Press CY - Washington, DC LA - English KW - Environment and Environmental Studies 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 - National Research Council A2 - Alfred Blumstein A2 - Jacqueline Cohen A2 - Jeffrey A. Roth A2 - Christy A. Visher TI - Criminal Careers and "Career Criminals,": Volume II SN - DO - 10.17226/928 PY - 1986 UR - https://nap.nationalacademies.org/catalog/928/criminal-careers-and-career-criminals-volume-ii PB - The National Academies Press CY - Washington, DC LA - English KW - Behavioral and Social Sciences AB - Volume II takes an in-depth look at the various aspects of criminal careers, including the relationship of alcohol and drug abuse to criminal careers, co-offending influences on criminal careers, issues in the measurement of criminal careers, accuracy of prediction models, and ethical issues in the use of criminal career information in making decisions about offenders. ER - TY - BOOK AU - Institute of Medicine A2 - Margie Patlak A2 - Sharyl Nass TI - Improving the Quality of Cancer Clinical Trials: Workshop Summary SN - DO - 10.17226/12146 PY - 2008 UR - https://nap.nationalacademies.org/catalog/12146/improving-the-quality-of-cancer-clinical-trials-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Scientists and clinicians seek a new paradigm that could improve the efficiency, cost-effectiveness, and overall success rate of cancer clinical trials, while maintaining the highest standards of quality. To explore innovative paradigms for cancer clinical trials and other ways to improve their quality, the National Cancer Policy Forum held a workshop, Improving the Quality of Cancer Clinical Trials, in Washington, DC. The main goals of the workshop were to examine new approaches to clinical trial design and execution that would: (1) better inform decisions and plans of those responsible for developing new cancer therapies (2) more rapidly move new diagnostic tests and treatments toward regulatory approval and use in the clinic (3) be less costly than current trials The resulting workshop summary will serve as input to the deliberations of an Institute of Medicine committee that will develop consensus-based recommendations for moving the field of cancer clinical trials forward. ER - TY - BOOK AU - National Research Council TI - Opportunities in Applied Environmental Research and Development SN - DO - 10.17226/2000 PY - 1991 UR - https://nap.nationalacademies.org/catalog/2000/opportunities-in-applied-environmental-research-and-development PB - The National Academies Press CY - Washington, DC LA - English KW - Environment and Environmental Studies AB - Research is the foundation of environmental protection. This volume reviews four areas of opportunity in applied environmental research and development: waste reduction, ecosystem and landscape change, anticipatory research, and long-term chemical toxicity. It presents the consensus of workshops held to explore these four areas as well as an introductory chapter that summarizes the committee's view of environmental research and development. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Erin Hammers Forstag A2 - Carolyn Shore TI - Accelerating the Development and Uptake of Rapid Diagnostics to Address Antibiotic Resistance: Proceedings of a Workshop SN - DO - 10.17226/27008 PY - 2023 UR - https://nap.nationalacademies.org/catalog/27008/accelerating-the-development-and-uptake-of-rapid-diagnostics-to-address-antibiotic-resistance PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The use and misuse of antibiotics contributes to the rise in drug-resistant bacteria - a serious and worsening threat to human health. The development and use of rapid point-of-care diagnostics in the healthcare setting plays an important role in avoiding unnecessary use of antimicrobials by providing clinicians with the right information at the right time to help them make decisions about appropriate drug treatment for patients. Diagnostics also have the capacity to support early detection and diagnosis of drug-resistant bacterial infections, enable disease surveillance, and help prevent disease spread. The National Academies Forum on Drug Discovery, Development, and Translation; Forum on Medical and Public Health Preparedness for Disasters and Emergencies; and Forum on Microbial Threats hosted an October 2022 workshop exploring the current landscape of rapid diagnostics to address antibiotic resistance, challenges and opportunities for spurring innovation, and practical next steps for accelerating the development of new diagnostic tools. ER - TY - BOOK AU - Institute of Medicine AU - National Academies of Sciences, Engineering, and Medicine A2 - Laurene A. Graig A2 - Jonathan K. Phillips A2 - Harold L. Moses TI - Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine SN - DO - 10.17226/21860 PY - 2016 UR - https://nap.nationalacademies.org/catalog/21860/biomarker-tests-for-molecularly-targeted-therapies-key-to-unlocking-precision PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Every patient is unique, and the evolving field of precision medicine aims to ensure the delivery of the right treatment to the right patient at the right time. In an era of rapid advances in biomedicine and enhanced understanding of the genetic basis of disease, health care providers increasingly have access to advanced technologies that may identify molecular variations specific to an individual patient, which subsequently can be targeted for treatment. Known as biomarker tests for molecularly targeted therapies, these complex tests have the potential to enable the selection of the most beneficial treatment (and also to identify treatments that may be harmful or ineffective) for the molecular underpinnings of an individual patient's disease. Such tests are key to unlocking the promise of precision medicine. Biomarker tests for molecularly targeted therapies represent a crucial area of focus for developing methods that could later be applicable to other areas of precision medicine. The appropriate regulatory oversight of these tests is required to ensure that they are accurate, reliable, properly validated, and appropriately implemented in clinical practice. Moreover, common evidentiary standards for assessing the beneficial impact of biomarker-guided therapy selection on patient outcomes, as well as the effective collection and sharing of information related to those outcomes, are urgently needed to better inform clinical decision making. Biomarker Tests of Molecularly Targeted Therapies examines opportunities for and challenges to the use of biomarker tests to select optimal therapy and offers recommendations to accelerate progress in this field. This report explores regulatory issues, reimbursement issues, and clinical practice issues related to the clinical development and use of biomarker tests for targeting therapies to patients. Properly validated, appropriately implemented biomarker tests hold the potential to enhance patient care and improve outcomes, and therefore addressing the challenges facing such tests is critical. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Kellyn Betts A2 - Andrea Hodgson TI - Advances in Causal Understanding for Human Health Risk-Based Decision-Making: Proceedings of a Workshop—in Brief DO - 10.17226/25004 PY - 2018 UR - https://nap.nationalacademies.org/catalog/25004/advances-in-causal-understanding-for-human-health-risk-based-decision-making PB - The National Academies Press CY - Washington, DC LA - English KW - Environment and Environmental Studies AB - Scientific tools and capabilities to examine relationships between environmental exposure and health outcomes have advanced and will continue to evolve. Researchers are using various tools, technologies, frameworks, and approaches to enhance our understanding of how data from the latest molecular and bioinformatic approaches can support causal frameworks for regulatory decisions. For this reason, on March 6-7, 2017, the National Academies' Standing Committee on Emerging Science for Environmental Health Decisions, held a 2-day workshop to explore advances in causal understanding for human health risk-based decision-making. The workshop aimed to explore different causal inference models, how they were conceived and are applied, new frameworks and tools for determining causality, and ultimately discussed gaps, challenges, and opportunities for integrating new data streams for determining causality. This workshop brought together environmental health researchers, toxicologists, statisticians, social scientists, epidemiologists, business and consumer representatives, science policy experts, and professionals from other fields who utilize different data streams for establishing causality in complex systems to discuss the topics outlined above. This Proceedings of a Workshop-in Brief summarizes the discussions that took place at the workshop. ER - TY - BOOK AU - Institute of Medicine A2 - Steve Olson A2 - Adam C. Berger TI - Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary SN - DO - 10.17226/13359 PY - 2012 UR - https://nap.nationalacademies.org/catalog/13359/genome-based-diagnostics-clarifying-pathways-to-clinical-use-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Biology and Life Sciences AB - The sequencing of the human genome and the identification of associations between specific genetic variants and diseases have led to an explosion of genomic-based diagnostic tests. These tests have the potential to direct therapeutic interventions, predict risk or onset of disease, or detect residual disease. As research progresses and an increasing number of associations are found, further tests will be developed that can aid in providing personalized treatment options for patients. However, the adoption of genomic diagnostic tests by health care providers has been limited due to a lack of evidence regarding the clinical utility of many tests. Health funders and practitioners lack the data necessary to distinguish which tests can improve practice or the clinical settings in which tests will provide the greatest value. The Roundtable on Translating Genomic-Based Research for Health held a workshop in November 2010 to determine what evidence is needed and how it is viewed by different stakeholders in order to develop genomic diagnostic tests of clinical value. Genome-Based Diagnostics summarizes the presentations and discussions that took place throughout the workshop. Two presentations, in particular, sparked extensive discussion. One presentation proposed that all genomic diagnostic tests be reviewed and approved by the Food and Drug Administration. The other observed that venture capitalists are no longer investing substantially in the development of genomic diagnostic tests because of a lack of clarity surrounding regulatory and reimbursement pathways. Both presentations suggested the need for major changes in the systems used to develop, regulate, and reimburse genomic diagnostic tests. The report also presents the perspectives of different stakeholders in the development of genomic diagnostic tests. Each stakeholder group has a different set of needs and issues of importance, yet commonalities among them are apparent, such as the need to put patients and health outcomes at the center of discussion and action. ER - TY - BOOK AU - National Research Council TI - Advanced Energetic Materials SN - DO - 10.17226/10918 PY - 2004 UR - https://nap.nationalacademies.org/catalog/10918/advanced-energetic-materials PB - The National Academies Press CY - Washington, DC LA - English KW - Engineering and Technology KW - Environment and Environmental Studies AB - Advanced energetic materials—explosive fill and propellants—are a critical technology for national security. While several new promising concepts and formulations have emerged in recent years, the Department of Defense is concerned about the nation’s ability to maintain and improve the knowledge base in this area. To assist in addressing these concerns, two offices within DOD asked the NRC to investigate and assess the scope and health of the U.S. R&D efforts in energetic materials. This report provides that assessment. It presents several findings about the current R&D effort and recommendations aimed at improving U.S. capabilities in developing new energetic materials technology. This study reviewed U.S. research and development in advanced energetics being conducted by DoD, the DoE national laboratories, industries, and academia, from a list provided by the sponsors. It also: (a) reviewed papers and technology assessments of non-U.S. work in advanced energetics, assessed important parameters, such as validity, viability, and the likelihood that each of these materials can be produced in quantity; (b) identified barriers to scale-up and production, and suggested technical approaches for addressing potential problems; and (c) suggested specific opportunities, strategies, and priorities for government sponsorship of technologies and manufacturing process development. ER - TY - BOOK AU - Institute of Medicine TI - Evaluation of the U.S. Department of Defense Persian Gulf Comprehensive Clinical Evaluation Program DO - 10.17226/9057 PY - 1996 UR - https://nap.nationalacademies.org/catalog/9057/evaluation-of-the-us-department-of-defense-persian-gulf-comprehensive-clinical-evaluation-program PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine ER - TY - BOOK AU - Institute of Medicine AU - National Academies of Sciences, Engineering, and Medicine A2 - Justin Snair A2 - Jack Hermann A2 - Lisa Brown A2 - Scott Wollek A2 - Erin Balogh A2 - Kimberly Maxfield TI - Potential Research Priorities to Inform Public Health and Medical Practice for Domestic Zika Virus: Workshop in Brief DO - 10.17226/23404 PY - 2016 UR - https://nap.nationalacademies.org/catalog/23404/potential-research-priorities-to-inform-public-health-and-medical-practice-for-domestic-zika-virus PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Given the recent rapid spread of Zika virus (ZIKV) throughout the Americas and the presence of its vector mosquito species within parts of the United States, RADM Nicole Lurie, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, determined an urgent need for additional research to better characterize ZIKV, especially those issues related to the means of transmission and infection during pregnancy. The National Academies of Sciences, Engineering, and Medicine convened a 1-day public workshop on February 16, 2016, to discuss and explore key factors associated with ZIKV. ER - TY - BOOK AU - Institute of Medicine A2 - Christine M. Micheel A2 - Sharly J. Nass A2 - Gilbert S. Omenn TI - Evolution of Translational Omics: Lessons Learned and the Path Forward SN - DO - 10.17226/13297 PY - 2012 UR - https://nap.nationalacademies.org/catalog/13297/evolution-of-translational-omics-lessons-learned-and-the-path-forward PB - The National Academies Press CY - Washington, DC LA - English KW - Biology and Life Sciences KW - Health and Medicine AB - Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials. ER - TY - BOOK AU - National Research Council A2 - Margaret Hilton TI - Protecting Student Records and Facilitating Education Research: A Workshop Summary SN - DO - 10.17226/12514 PY - 2009 UR - https://nap.nationalacademies.org/catalog/12514/protecting-student-records-and-facilitating-education-research-a-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Policy for Science and Technology KW - Computers and Information Technology KW - Behavioral and Social Sciences KW - Surveys and Statistics AB - Designed to protect the privacy of individual student test scores, grades, and other education records, the Family Educational Rights and Privacy Act (FERPA) of 1974 places limits the access of educational researches, and slows research not only in education but also in related fields, such as child welfare and health. Recent trends have converged to greatly increase the supply of data on student performance in public schools. Education policies now emphasize education standards and testing to measure progress toward those standards, as well as rigorous education research. At the same time, private firms and public agencies, including schools, have replaced most paper records with electronic data systems. Although these databases represent a rich source of longitudinal data, researchers' access to the individually identifiable data they contain is limited by the privacy protections of FERPA. To explore possibilities for data access and confidentiality in compliance with FERPA and with the Common Rule for the Protection of Human Subjects, the National Academies and the American Educational Research Association convened the Workshop on Protecting Student Records and Facilitating Education Research in April 2008. ER -