TY - BOOK AU - Institute of Medicine A2 - Denise Caruso A2 - Rebecca A. English A2 - Anne B. Claiborne TI - Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: Workshop Summary SN - DO - 10.17226/18870 PY - 2014 UR - https://nap.nationalacademies.org/catalog/18870/characterizing-and-communicating-uncertainty-in-the-assessment-of-benefits-and-risks-of-pharmaceutical-products PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle. ER - TY - BOOK AU - Institute of Medicine A2 - Janet E. Joy A2 - Richard B. Johnston, Jr. TI - Multiple Sclerosis: Current Status and Strategies for the Future SN - DO - 10.17226/10031 PY - 2001 UR - https://nap.nationalacademies.org/catalog/10031/multiple-sclerosis-current-status-and-strategies-for-the-future PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Multiple sclerosis is a chronic and often disabling disease of the nervous system, affecting about 1 million people worldwide. Even though it has been known for over a hundred years, no cause or cure has yet been discovered—but now there is hope. New therapies have been shown to slow the disease progress in some patients, and the pace of discoveries about the cellular machinery of the brain and spinal cord has accelerated. This book presents a comprehensive overview of multiple sclerosis today, as researchers seek to understand its processes, develop therapies that will slow or halt the disease and perhaps repair damage, offer relief for specific symptoms, and improve the abilities of MS patients to function in their daily lives. The panel reviews existing knowledge and identifies key research questions, focusing on: Research strategies that have the greatest potential to understand the biological mechanisms of recovery and to translate findings into specific strategies for therapy. How people adapt to MS and the research needed to improve the lives of people with MS. Management of disease symptoms (cognitive impairment, depression, spasticity, vision problems, and others). The committee also discusses ways to build and financially support the MS research enterprise, including a look at challenges inherent in designing clinical trials. This book will be important to MS researchers, research funders, health care advocates for MS research and treatment, and interested patients and their families. ER - TY - BOOK AU - Institute of Medicine A2 - Alison Mack A2 - Erin Balogh A2 - Christine M. Micheel TI - Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary SN - DO - 10.17226/13038 PY - 2011 UR - https://nap.nationalacademies.org/catalog/13038/perspectives-on-biomarker-and-surrogate-endpoint-evaluation-discussion-forum-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations. ER - TY - BOOK AU - Institute of Medicine A2 - Christine M. Micheel A2 - John R. Ball TI - Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease SN - DO - 10.17226/12869 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12869/evaluation-of-biomarkers-and-surrogate-endpoints-in-chronic-disease PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Emily A. Callahan TI - Challenges and Opportunities for Precision and Personalized Nutrition: Proceedings of a Workshop SN - DO - 10.17226/26299 PY - 2022 UR - https://nap.nationalacademies.org/catalog/26299/challenges-and-opportunities-for-precision-and-personalized-nutrition-proceedings-of PB - The National Academies Press CY - Washington, DC LA - English KW - Food and Nutrition AB - The Food Forum of the National Academies of Sciences, Engineering, and Medicine convened a virtual workshop, Challenges and Opportunities for Precision and Personalized Nutrition, on August 10-12, 2021. The workshop explored potential challenges and opportunities in the application of precision and personalized nutrition approaches to optimize dietary guidance and improve nutritional status. Workshops presenters discussed current precision and personalized nutrition research methodologies, limitations in data and design, adapting technologies for utilization, and policy and regulatory challenges. This Proceedings of a Workshop summarizes the presentations and discussions of the workshop. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Shiriki Kumanyika A2 - Maria P. Oria TI - Guiding Principles for Developing Dietary Reference Intakes Based on Chronic Disease SN - DO - 10.17226/24828 PY - 2017 UR - https://nap.nationalacademies.org/catalog/24828/guiding-principles-for-developing-dietary-reference-intakes-based-on-chronic-disease PB - The National Academies Press CY - Washington, DC LA - English KW - Food and Nutrition KW - Health and Medicine AB - Since 1938 and 1941, nutrient intake recommendations have been issued to the public in Canada and the United States, respectively. Currently defined as the Dietary Reference Intakes (DRIs), these values are a set of standards established by consensus committees under the National Academies of Sciences, Engineering, and Medicine and used for planning and assessing diets of apparently healthy individuals and groups. In 2015, a multidisciplinary working group sponsored by the Canadian and U.S. government DRI steering committees convened to identify key scientific challenges encountered in the use of chronic disease endpoints to establish DRI values. Their report, Options for Basing Dietary Reference Intakes (DRIs) on Chronic Disease: Report from a Joint US-/Canadian-Sponsored Working Group, outlined and proposed ways to address conceptual and methodological challenges related to the work of future DRI Committees. This report assesses the options presented in the previous report and determines guiding principles for including chronic disease endpoints for food substances that will be used by future National Academies committees in establishing DRIs. ER - TY - BOOK AU - Institute of Medicine TI - Scientific Standards for Studies on Modified Risk Tobacco Products SN - DO - 10.17226/13294 PY - 2012 UR - https://nap.nationalacademies.org/catalog/13294/scientific-standards-for-studies-on-modified-risk-tobacco-products PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA. ER - TY - BOOK AU - Institute of Medicine A2 - Miriam Davis A2 - Sarah Hanson A2 - Bruce Altevogt TI - Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships: Workshop Summary SN - DO - 10.17226/11947 PY - 2008 UR - https://nap.nationalacademies.org/catalog/11947/neuroscience-biomarkers-and-biosignatures-converging-technologies-emerging-partnerships-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Biomarkers, or biological markers, are quantitative measurements that offer researchers and clinicians valuable insight into diagnosis, treatment and prognosis for many disorders and diseases. A major goal in neuroscience medical research is establishing biomarkers for disorders of the nervous system. Given the promising potential and necessity for neuroscience biomarkers, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened a public workshop and released the workshop summary entitled Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships. The workshop brought together experts from multiple areas to discuss the most promising and practical arenas in neuroscience in which biomarkers will have the greatest impact. The main objective of the workshop was to identify and discuss biomarker targets that are not currently being aggressively pursued but that could have the greatest near-term impact on the rate at which new treatments are brought forward for psychiatric and neurological disorders. ER - TY - BOOK AU - Institute of Medicine A2 - Diana E. Pankevich A2 - Miriam Davis A2 - Bruce M. Altevogt TI - Glutamate-Related Biomarkers in Drug Development for Disorders of the Nervous System: Workshop Summary SN - DO - 10.17226/13146 PY - 2011 UR - https://nap.nationalacademies.org/catalog/13146/glutamate-related-biomarkers-in-drug-development-for-disorders-of-the-nervous-system PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Glutamate is the most pervasive neurotransmitter in the central nervous system (CNS). Despite this fact, no validated biological markers, or biomarkers, currently exist for measuring glutamate pathology in CNS disorders or injuries. Glutamate dysfunction has been associated with an extensive range of nervous system diseases and disorders. Problems with how the neurotransmitter glutamate functions in the brain have been linked to a wide variety of disorders, including schizophrenia, Alzheimer's, substance abuse, and traumatic brain injury. These conditions are widespread, affecting a large portion of the United States population, and remain difficult to treat. Efforts to understand, treat, and prevent glutamate-related disorders can be aided by the identification of valid biomarkers. The Institute of Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop on June 21-22, 2010, to explore ways to accelerate the development, validation, and implementation of such biomarkers. Glutamate-Related Biomarkers in Drug Development for Disorders of the Nervous System: Workshop Summary investigates promising current and emerging technologies, and outlines strategies to procure resources and tools to advance drug development for associated nervous system disorders. Moreover, this report highlights presentations by expert panelists, and the open panel discussions that occurred during the workshop. ER - TY - BOOK AU - National Research Council TI - The Prevention and Treatment of Missing Data in Clinical Trials SN - DO - 10.17226/12955 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12955/the-prevention-and-treatment-of-missing-data-in-clinical-trials PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Behavioral and Social Sciences KW - Surveys and Statistics AB - Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data. ER - TY - BOOK AU - Institute of Medicine AU - National Academies of Sciences, Engineering, and Medicine A2 - Joe Alper A2 - Amy Geller TI - How Modeling Can Inform Strategies to Improve Population Health: Workshop Summary SN - DO - 10.17226/21807 PY - 2016 UR - https://nap.nationalacademies.org/catalog/21807/how-modeling-can-inform-strategies-to-improve-population-health-workshop PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - In April 2015, the Institute of Medicine convened a workshop to explore the potential uses of simulation and other types of modeling for the purpose of selecting and refining potential strategies, ranging from interventions to investments, to improve the health of communities and the nation's health. Participants worked to identify how modeling could inform population health decision making based on lessons learned from models that have been, or have not been, used successfully, opportunities and barriers to incorporating models into decision making, and data needs and opportunities to leverage existing data and to collect new data for modeling. This report summarizes the presentations and discussions from this workshop. ER - TY - BOOK AU - Institute of Medicine A2 - Theresa Wizemann A2 - Adam C. Berger TI - Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary SN - DO - 10.17226/13133 PY - 2011 UR - https://nap.nationalacademies.org/catalog/13133/generating-evidence-for-genomic-diagnostic-test-development-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Ten years after the sequencing of the human genome, scientists have developed genetic tests that can predict a person's response to certain drugs, estimate the risk of developing Alzheimer's disease, and make other predictions based on known links between genes and diseases. However, genetic tests have yet to become a routine part of medical care, in part because there is not enough evidence to show they help improve patients' health. The Institute of Medicine (IOM) held a workshop to explore how researchers can gather better evidence more efficiently on the clinical utility of genetic tests. Generating Evidence for Genomic Diagnostic Test Development compares the evidence that is required for decisions regarding clearance, use, and reimbursement, to the evidence that is currently generated. The report also addresses innovative and efficient ways to generate high-quality evidence, as well as barriers to generating this evidence. Generating Evidence for Genomic Diagnostic Test Development contains information that will be of great value to regulators and policymakers, payers, health-care providers, researchers, funders, and evidence-based review groups. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Lisa Bain A2 - Chanel Matney A2 - Sheena M. Posey Norris A2 - Clare Stroud TI - Exploring Psychedelics and Entactogens as Treatments for Psychiatric Disorders: Proceedings of a Workshop SN - DO - 10.17226/26648 PY - 2022 UR - https://nap.nationalacademies.org/catalog/26648/exploring-psychedelics-and-entactogens-as-treatments-for-psychiatric-disorders-proceedings PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Psychiatric illnesses - such as major depressive disorder, anxiety disorder, substance use disorder, and posttraumatic stress disorder (PTSD) - are widely prevalent and represent a substantial health burden worldwide. Yet, conventional medications for mental illnesses often fail to provide relief to patients' disruptive and disabling symptoms. Existing and emerging evidence that psychedelics (e.g., LSD and psilocybin) and entactogens (e.g., MDMA) may be useful as tools to alleviate mental illness has sparked a renaissance of interest by investigators, clinicians, drug developers, and patient advocates in recent years. While promising data on therapeutic efficacy has energized research and development, resolving the mechanisms of action will be important for optimizing the efficacy and safety of these medicines. Further, evaluating the effect of psychedelics and entactogens on mood and behavior comes with unique challenges still in need of resolution. These include unresolved questions relating to blinding, placebo and nocebo effects, and the impact of psychosocial contexts. In response to this renewed interest, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders convened a workshop on March 29-30, 2022. The workshop brought together a diverse group of stakeholders to explore the use of psychedelics and entactogens as treatments for psychiatric disorders. This Proceedings of a Workshop summarizes the presentations and discussions of the workshop. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Rebecca English A2 - Lyle Carrera A2 - Ashley Bologna A2 - Joe Alper TI - Amyotrophic Lateral Sclerosis: Accelerating Treatments and Improving Quality of Life: Proceedings of a Workshop–in Brief DO - 10.17226/27395 PY - 2023 UR - https://nap.nationalacademies.org/catalog/27395/amyotrophic-lateral-sclerosis-accelerating-treatments-and-improving-quality-of-life PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Amyotrophic lateral sclerosis (ALS) is a rapidly progressive, invariably fatal neurological disease. No present treatments can stop or reverse the disease, although Food and Drug Administration (FDA)-approved formulations may extend life by several months. As part of the information-gathering phase of a study on ALS, the National Academies Board on Health Care Services and Board on Health Sciences Policy cohosted a virtual public workshop series in August and September 2023 to identify key actions for the public, private, and nonprofit sectors to undertake to make ALS a livable disease within a decade. Speakers explored topics including access to high-quality, evidence-based ALS care, the lived experience of ALS, and ALS research and therapeutic development. This publication summarizes the presentations and discussion of the workshop. ER - TY - BOOK AU - Transportation Research Board AU - National Academies of Sciences, Engineering, and Medicine A2 - Harold L. Von Quintus A2 - Shree Rao A2 - Praveen Gopisetti A2 - Chetana Rao TI - Incorporating Nondestructive Testing in Quality Assurance of Highway Pavement Construction: Manual DO - 10.17226/27443 PY - 2023 UR - https://nap.nationalacademies.org/catalog/27443/incorporating-nondestructive-testing-in-quality-assurance-of-highway-pavement-construction-manual PB - The National Academies Press CY - Washington, DC LA - English KW - Transportation and Infrastructure AB - State departments of transportation (DOTs), as part of their routine practice, use various quality assurance (QA) procedures in their acceptance process for highway pavement construction. Absent from this QA process is the use of nondestructive testing (NDT) methods, despite their many potential benefits to the process. NCHRP Research Report 1082: Incorporating Nondestructive Testing in Quality Assurance of Highway Pavement Construction: Manual, from TRB's National Cooperative Highway Research Program, is a manual designed to assist state DOTs in selecting and incorporating applicable NDT methods into their QA programs for highway pavement construction. Supplemental to the report is NCHRP Web-Only Document 375: Incorporating Nondestructive Testing in Quality Assurance of Highway Pavement Construction: Conduct of Research Report. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Jennifer Saunders TI - New Approach Methods (NAMs) for Human Health Risk Assessment: Proceedings of a Workshop–in Brief DO - 10.17226/26496 PY - 2022 UR - https://nap.nationalacademies.org/catalog/26496/new-approach-methods-nams-for-human-health-risk-assessment-proceedings PB - The National Academies Press CY - Washington, DC LA - English KW - Environment and Environmental Studies AB - Animal testing is often used to assess the potential risks, uses, and environmental impacts of chemicals. New Approach Methods (NAMs) are technologies and approaches (including computational modeling, in vitro assays, and testing using alternative animal species) that can inform hazard and risk assessment decisions without the use of animal testing. The National Academies of Sciences, Engineering and Medicine convened a 1-day virtual public workshop on December 9, 2021, to address the potential utility and expectations for the future use of NAMs in risk assessment and to reflect on the challenges to their implementation. The workshop focused on how traditional toxicity studies are used in informing chemical safety decisions and variability and concordance of traditional mammalian toxicity studies. This publication summarizes the presentation and discussion of the workshop. ER - TY - BOOK AU - National Academies of Sciences, Engineering, and Medicine A2 - Leslie Pray A2 - Ann L. Yaktine TI - Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop SN - DO - 10.17226/25023 PY - 2018 UR - https://nap.nationalacademies.org/catalog/25023/global-harmonization-of-methodological-approaches-to-nutrient-intake-recommendations-proceedings PB - The National Academies Press CY - Washington, DC LA - English KW - Food and Nutrition AB - The National Academies of Sciences, Engineering, and Medicine convened a public workshop in September 2017 to explore the evidence for achieving global harmonization of methodological approaches to establishing nutrient intake recommendations. Participants reviewed current nutrient intake recommendations, discussed the feasibility of harmonizing approaches to setting such recommendations globally, examined the development of principles by which they may be applied in diverse contexts that relate to individuals or populations, or regulatory purposes, and examined perceptions and acceptance of nutrient intake recommendations by different stakeholders. This publication summarizes the presentations and discussions from the workshop. ER - TY - BOOK AU - Institute of Medicine A2 - Marilyn J. Field A2 - Richard E. Behrman TI - Ethical Conduct of Clinical Research Involving Children SN - DO - 10.17226/10958 PY - 2004 UR - https://nap.nationalacademies.org/catalog/10958/ethical-conduct-of-clinical-research-involving-children PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Policy for Science and Technology AB - In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular. 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 - Institute of Medicine A2 - Leslie Pray A2 - Ann L. Yaktine A2 - Diana Pankevich TI - Caffeine in Food and Dietary Supplements: Examining Safety: Workshop Summary SN - DO - 10.17226/18607 PY - 2014 UR - https://nap.nationalacademies.org/catalog/18607/caffeine-in-food-and-dietary-supplements-examining-safety-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Food and Nutrition AB - Caffeine in Food and Dietary Supplements is the summary of a workshop convened by the Institute of Medicine in August 2013 to review the available science on safe levels of caffeine consumption in foods, beverages, and dietary supplements and to identify data gaps. Scientists with expertise in food safety, nutrition, pharmacology, psychology, toxicology, and related disciplines; medical professionals with pediatric and adult patient experience in cardiology, neurology, and psychiatry; public health professionals; food industry representatives; regulatory experts; and consumer advocates discussed the safety of caffeine in food and dietary supplements, including, but not limited to, caffeinated beverage products, and identified data gaps. Caffeine, a central nervous stimulant, is arguably the most frequently ingested pharmacologically active substance in the world. Occurring naturally in more than 60 plants, including coffee beans, tea leaves, cola nuts and cocoa pods, caffeine has been part of innumerable cultures for centuries. But the caffeine-in-food landscape is changing. There are an array of new caffeine-containing energy products, from waffles to sunflower seeds, jelly beans to syrup, even bottled water, entering the marketplace. Years of scientific research have shown that moderate consumption by healthy adults of products containing naturally-occurring caffeine is not associated with adverse health effects. The changing caffeine landscape raises concerns about safety and whether any of these new products might be targeting populations not normally associated with caffeine consumption, namely children and adolescents, and whether caffeine poses a greater health risk to those populations than it does for healthy adults. This report delineates vulnerable populations who may be at risk from caffeine exposure; describes caffeine exposure and risk of cardiovascular and other health effects on vulnerable populations, including additive effects with other ingredients and effects related to pre-existing conditions; explores safe caffeine exposure levels for general and vulnerable populations; and identifies data gaps on caffeine stimulant effects. ER -