@BOOK{NAP author = "Institute of Medicine", title = "Halcion: An Independent Assessment of Safety and Efficacy Data", isbn = "978-0-309-05976-3", abstract = "Regulatory agencies within the United States and the United Kingdom, among several other countries, have reviewed extensively the safety and efficacy of Halcion (triazolam)\u2014a once commonly used hypnotic drug. Concerns began to emerge about the safety of Halcion when a Dutch physician reported a possible link between it and a syndrome that included such effects as depression, amnesia, hallucinations, and increased anxiety. In addition, in 1991 its manufacturer, Upjohn, noted that \"errors had been identified in a report of one of the clinical studies included in the original\" application for approval. Since then, the drug has been removed from the market in several countries, whereas in the United States and Canada, the drug's labeling has been modified to reduce the recommended dose and duration of treatment and to heighten awareness of possible side effects. Yet different data and analyses have resulted in conflicting messages that are difficult to reconcile and interpret. In response to a request from the Food and Drug Administration to resolve these controversial issues related to the safety and efficacy of Halcion, this IOM book assesses the adequacy of the drug's clinical trials; the quality and quantity of data on adverse reactions; overall confidence in the data on effectiveness, adverse events, and side effects at different doses; and whether additional studies are needed.", url = "https://nap.nationalacademies.org/catalog/5940/halcion-an-independent-assessment-of-safety-and-efficacy-data", year = 1997, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "A. Catharine Ross and Christine L. Taylor and Ann L. Yaktine and Heather B. Del Valle", title = "Dietary Reference Intakes for Calcium and Vitamin D", isbn = "978-0-309-16394-1", abstract = "Calcium and vitamin D are essential nutrients for the human body. Establishing the levels of these nutrients that are needed by the North American population is based on the understanding of the health outcomes that calcium and vitamin D affect. It is also important to establish how much of each nutrient may be \"too much.\"\nDietary Reference Intakes for Calcium and Vitamin D provides reference intake values for these two nutrients. The report updates the DRI values defined in Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride, the 1997 study from the Institute of Medicine. This 2011 book provides background information on the biological functions of each nutrient, reviews health outcomes that are associated with the intake of calcium and vitamin D, and specifies Estimated Average Requirements and Recommended Dietary Allowances for both. It also identifies Tolerable Upper Intake Levels, which are levels above wish the risk for harm may increase. The book includes an overview of current dietary intake in the U.S. and Canada, and discusses implications of the study. A final chapter provides research recommendations.\nThe DRIs established in this book incorporate current scientific evidence about the roles of vitamin D and calcium in human health and will serve as a valuable guide for a range of stakeholders including dietitians and other health professionals, those who set national nutrition policy, researchers, the food industry, and private and public health organizations and partnerships. \n ", url = "https://nap.nationalacademies.org/catalog/13050/dietary-reference-intakes-for-calcium-and-vitamin-d", year = 2011, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine and Institute of Medicine", title = "The Richard and Hinda Rosenthal Lectures -- 2001: Exploring Complementary and Alternative Medicine", isbn = "978-0-309-08503-8", abstract = "The Rosenthal lecture included in this volume explores the world of complementary medicine and its implications for medical research, clinical practice, and policy in the United States.", url = "https://nap.nationalacademies.org/catalog/10547/the-richard-and-hinda-rosenthal-lectures-2001-exploring-complementary-and", year = 2003, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Lisa Bain and Chanel Matney and Clare Stroud", title = "Novel Molecular Targets for Mood Disorders and Psychosis: Proceedings of a Workshop", isbn = "978-0-309-68590-0", abstract = "Mood disorders - including depression and bipolar disorder - are common, disabling, and potentially lethal disorders, characterized by a shortened lifespan from comorbid medical illness and rising suicide rates. Medications for these conditions have been shown to be insufficiently effective in the majority of people who take them, and there remains a tremendous unmet medical need. Recent advances towards understanding the mechanisms of action for psychiatric medicines have led to the identification of potential novel molecular targets and agents for treating mood disorders. While these promising avenues for further investigation have re-energized scientific research in this area, many open questions remain. In response to this interest, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders convened a workshop in March 2021, Novel Molecular Targets for Mood Disorders and Psychosis.\nThe goal of this workshop was to explore the landscape of novel pharmacologic treatments for psychiatric disorders, review the challenges and opportunities that have been highlighted by the development of recently approved drugs, and reflect on how to apply those lessons learned towards current and future efforts to identify and validate additional novel molecular targets. With a grounding in the personal experiences of patients living with depression and schizophrenia, workshop participants discussed the scientific, clinical, technological, regulatory, and ethical considerations of this topic. Examples of drug classes discussed in the workshop include antagonists for NMDA (N-methyl-D-aspartate) receptors and GABA (gamma-aminobutyric acid) receptors, as well as modulators for muscarinic and serotonergic receptors. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/26218/novel-molecular-targets-for-mood-disorders-and-psychosis-proceedings-of", year = 2021, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine and National Academies of Sciences, Engineering, and Medicine", editor = "Lisa Bain and Clare Stroud", title = "Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: Workshop Summary", isbn = "978-0-309-37393-7", abstract = "Major depressive disorder (MDD) is recognized worldwide as a major cause of disability, morbidity, and mortality. According to the World Health Organization, unipolar depressive disorders affect more than 150 million people around the world and represent the leading cause of years lost due to disability among both men and women. In the United States alone, nearly 8 percent of persons over the age of 12 report current depression. MDD has long been defined primarily as a mood disorder. However,more recently people have begun to recognize effects on cognition as a major contributor to the disablement that accompanies depression and to consider this an underrecognized treatment target for depression.\nTo explore how best to enable the discovery, development, and translation of treatments for cognitive dysfunction in depression, including a focus on the regulatory path forward, the Institute of Medicine's Forum on Neuroscience and Nervous Disorders convened key stakeholders at a workshop in February 2015. This report summarizes the presentations from expert speakers and discussions among workshop participants.", url = "https://nap.nationalacademies.org/catalog/21745/enabling-discovery-development-and-translation-of-treatments-for-cognitive-dysfunction-in-depression", year = 2015, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Alan I. Leshner and Story Landis and Clare Stroud and Autumn Downey", title = "Preventing Cognitive Decline and Dementia: A Way Forward", isbn = "978-0-309-45959-4", abstract = "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.\n\nPreventing 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.", url = "https://nap.nationalacademies.org/catalog/24782/preventing-cognitive-decline-and-dementia-a-way-forward", year = 2017, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence", isbn = "978-0-309-10280-3", abstract = "Drug dependence is a complex, chronic, relapsing condition that is often accompanied by severe health, psychological, economic, legal, and social consequences. Injecting drug users are particularly vulnerable to HIV and other bloodborne infections (such as hepatitis C) as a result of sharing contaminated injecting equipment. All drug-dependent individuals, including injecting drug users (IDUs), may be at increased risk of HIV infection because of high-risk sexual behaviors. There are an estimated 13.2 million injecting drug users (IDUs) world-wide\u201478 percent of whom live in developing or transitional countries. The sharing of contaminated injecting equipment has become a major driving force of the global AIDS epidemic and is the primary mode of HIV transmission in many countries. In some cases, epidemics initially fueled by the sharing of contaminated injecting equipment are spreading through sexual transmission from IDUs to non-injecting populations, and through perinatal transmission to newborns. Reversing the rise of HIV infections among IDUs has thus become an urgent global public health challenge\u2014one that remains largely unmet.\n\nIn response to this challenge, the Institute of Medicine convened a public workshop in Geneva in December 2005 to gather information from experts on IDU-driven HIV epidemics in the most affected regions of the world with an emphasis on countries throughout Eastern Europe, the Commonwealth of Independent States, and significant parts of Asia. Experts from other regions also provided information on their experiences in preventing HIV infection among IDUs. This report provides a summary of the workshop discussions.\n\nPreventing HIV Infection among Injecting Drug Users in High Risk Countries describes the evidence on the intermediate outcomes of drug-related risk and sex-related risk prior to examining the impact on HIV transmission. This report focuses on programs that are designed to prevent the transmission of HIV among injecting drug users. These programs range from efforts to curtail non-medical drug use to those that encourage reduction in high-risk behavior among drug users. Although the report focuses on HIV prevention for IDUs in high-risk countries, the Committee considered evidence from countries around the world. The findings and recommendations of this report are also applicable to countries where injecting drug use is not the primary driver, but in which injection drug use is nevertheless associated with significant HIV transmission.", url = "https://nap.nationalacademies.org/catalog/11731/preventing-hiv-infection-among-injecting-drug-users-in-high-risk-countries", year = 2007, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Sarah Hanson and Miriam Davis and Bruce Altevogt", title = "CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary", isbn = "978-0-309-14883-2", abstract = "The Food and Drug Administration (FDA) now requires that all clinical trials for drugs that affect the central nervous system\u2014including psychiatric drugs\u2014are assessed for whether that drug might cause suicidal ideation or behavior. The Institute of Medicine's (IOM) Forum on Neuroscience and Nervous System Disorders hosted a meeting on June 26, 2009, to discuss the FDA's new policy and how to analyze best whether suicidal thoughts predict actual suicidal behavior in the near future.", url = "https://nap.nationalacademies.org/catalog/12829/cns-clinical-trials-suicidality-and-data-collection-workshop-summary", year = 2010, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Bernard M. Rosof and Lyla M. Hernandez", title = "Gulf War Veterans: Treating Symptoms and Syndromes", isbn = "978-0-309-07587-9", abstract = "Ten years after the end of the Gulf War, questions continue to be raised about the health of U.S. service personnel who fought in that war. A primary concern is whether Gulf War veterans are receiving effective treatments for their health problems. Section 105 of the Veterans Program Enhancement Act of 1998 mandates that the Department of Veterans Affairs (VA) ask the Institute of Medicine (IOM) to convene a committee that would identify a method for assessing treatment effectiveness and describe already-validated treatments for Gulf War veterans' health problems, including the problem of medically unexplained symptoms. The specific charge to the committee is to (1) identify and describe approaches for assessing treatment effectiveness; (2) identify illnesses and conditions among veterans of the Gulf War, using data obtained from the VA and the Department of Defense (DoD) Gulf War Registries, as well as information in published articles; and (3) for these identified conditions and illnesses, identify validated models of treatment (to the extent that such treatments exist), or identify new approaches, theories, or research on the management of patients with these conditions if validated treatment models are not available.", url = "https://nap.nationalacademies.org/catalog/10185/gulf-war-veterans-treating-symptoms-and-syndromes", year = 2001, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Barbara O. Schneeman and Ann L. Yaktine and Alice Vorosmarti", title = "Scanning for New Evidence on Riboflavin to Support a Dietary Reference Intake Review", isbn = "978-0-309-67545-1", abstract = "The Dietary Reference Intakes (DRIs) are a set of evidence-based nutrient reference values for intakes that include the full range of age, gender, and life stage groups in the US and Canada. At the request of the U.S. Department of Agriculture, Agricultural Research Service and the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, the National Academies of Science, Engineering, and Medicine convened an ad hoc committee to carry out a literature search and evidence scan of the peer-reviewed published literature on indicators of nutritional requirements, toxicity, and chronic disease risk reduction for riboflavin.\nScanning for New Evidence on Riboflavin to Support a Dietary Reference Intake Review builds on the methodology for evidence scanning nutrients (which have existing DRIs) to determine whether there is new and relevant knowledge available that may merit a formal reexamination of DRIs for riboflavin. This report offers comments on the methodological approach to the evidence scan and discusses its findings and interpretation of the process to provide the study sponsors with a greater context to support their interpretation and application of the reported results.", url = "https://nap.nationalacademies.org/catalog/26188/scanning-for-new-evidence-on-riboflavin-to-support-a-dietary-reference-intake-review", year = 2021, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Stephen W. Lagakos and Alicia R. Gable", title = "Methodological Challenges in Biomedical HIV Prevention Trials", isbn = "978-0-309-11430-1", abstract = "The number of people infected with HIV or living with AIDS is increasing at unprecedented rates as various scientists, organizations, and institutions search for innovative solutions to combating and preventing the disease. At the request of the Bill & Melinda Gates Foundation, Methodological Challenges in Biomedical HIV Prevention Trials addresses methodological challenges in late-stage nonvaccine biomedical HIV prevention trials with a specific focus on microbicide and pre-exposure prophylaxis trials. This book recommends a number of ways to improve the design, monitoring, and analysis of late-stage clinical trials that evaluate nonvaccine biomedical interventions. The objectives include identifying a beneficial method of intervention, enhancing quantification of the impact, properly assessing the effects of using such an intervention, and reducing biases that can lead to false positive trial results.\n\nAccording to Methodological Challenges in Biomedical HIV Prevention Trials, the need to identify a range of effective, practical, and affordable preventive strategies is critical. Although a large number of promising new HIV prevention strategies and products are currently being tested in late-stage clinical trials, these trials face a myriad of methodological challenges that slow the pace of research and limit the ability to identify and fully evaluate effective biomedical interventions. \n ", url = "https://nap.nationalacademies.org/catalog/12056/methodological-challenges-in-biomedical-hiv-prevention-trials", year = 2008, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Susan Thaul and Dana Hotra", title = "An Assessment of the NIH Women's Health Initiative", isbn = "978-0-309-04989-4", abstract = "The National Institutes of Health Women's Health Initiative (WHI) is the largest research study ever funded by NIH ($625 million over 14 years) and is designed to test strategies to prevent cardiovascular disease, breast cancer, and osteoporotic fractures\u2014leading causes of death, disability, and decreased quality of life for older women. Although the WHI has already begun, serious questions remain about its design, cost, and the likelihood that it can answer the questions it asks. This book evaluates whether the effort can be justified scientifically.", url = "https://nap.nationalacademies.org/catalog/2271/an-assessment-of-the-nih-womens-health-initiative", year = 1993, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Robert Earl and Catherine E. Woteki", title = "Iron Deficiency Anemia: Recommended Guidelines for the Prevention, Detection, and Management Among U.S. Children and Women of Childbearing Age", isbn = "978-0-309-04987-0", abstract = "This book summarizes information related to public health measures on the prevention, detection, and management of iron deficiency anemia. It presents draft guidelines and recommendations related to this area, as applicable in primary health care and public health clinic settings, and it formulates recommendations for research. This volume is intended both to provide a common frame of reference for health professionals in preventing and treating iron deficiency anemia and to enable the U.S. Centers for Disease Control and Prevention to prepare national guidelines and recommendations for the prevention and control of iron deficiency anemia.", url = "https://nap.nationalacademies.org/catalog/2251/iron-deficiency-anemia-recommended-guidelines-for-the-prevention-detection-and", year = 1993, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Joe Alper and Eeshan Khandekar and Carolyn Shore", title = "Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop", isbn = "978-0-309-49488-5", abstract = "Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. \n\nOn November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/25502/virtual-clinical-trials-challenges-and-opportunities-proceedings-of-a-workshop", year = 2019, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "David A. Savitz and Anne N. Styka", title = "Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis", isbn = "978-0-309-67210-8", abstract = "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\nAt 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. ", url = "https://nap.nationalacademies.org/catalog/25688/assessment-of-long-term-health-effects-of-antimalarial-drugs-when-used-for-prophylaxis", year = 2020, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Lisa Bain and Noam I. Keren and Clare Stroud", title = "Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop", isbn = "978-0-309-45026-3", abstract = "Multimodal therapy approaches that combine interventions aimed at different aspects of disease are emerging as potential\u2014and perhaps essential\u2014ways to enhance clinical outcomes for patients with psychiatric and neurological disorders. In order to examine the general principles underlying multimodal therapies and to explore challenges, potential barriers, and opportunities for their development, the National Academies of Sciences, Engineering, and Medicine convened a workshop in June 2016. Participants explored scientific, clinical, regulatory, and reimbursement issues related to multimodal approaches and potential opportunities to enhance clinical outcomes for individuals with nervous system disorders. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/23657/developing-multimodal-therapies-for-brain-disorders-proceedings-of-a-workshop", year = 2017, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", title = "Selected Immune Disorders and Disability", isbn = "978-0-309-68949-6", abstract = "The U.S. Social Security Administration (SSA) administers the Social Security Disability Insurance program and the Supplemental Security Income program. As part of their process, immune system disorders are evaluated under Listing of Impairments 14.00 for adults and 114.00 for children. At the request of the SSA, the National Academies of Sciences, Engineering, and Medicine assembled a committee to review selected conditions related to the immune system. In particular, the SSA was interested in the current status of the diagnosis, treatment, and prognosis of immune system disorders including systemic lupus erythematosus (SLE), scleroderma, polymyositis, Sjogren's syndrome\/disease, and inflammatory arthritis.\nThis report provides an overview of the current status of the diagnosis, treatment, and prognosis of these immune system disorders in the U.S. population and the relative levels of functional limitation typically associated with them, common treatments, and other considerations.", url = "https://nap.nationalacademies.org/catalog/26595/selected-immune-disorders-and-disability", year = 2022, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Megan Snair and Chanel Matney and Katherine Bowman", title = "Biomarkers for Traumatic Brain Injury: Proceedings of a Workshop", isbn = "978-0-309-70164-8", abstract = "The National Academies Forum on Traumatic Brain Injury (TBI) convened a workshop in September 2022 to explore biomarkers used to more precisely and objectively diagnose and categorize suspected TBIs. Session discussions addressed developments in TBI biomarker classes including neuroimaging, blood-based, electrophysiological, and other physiological markers; how biomarkers may be used to better guide and monitor treatment after injury; and how they can be used to refine future research studies. Speakers also discussed potential impacts of biomarkers across the trajectory of TBI care and research, efforts to translate and incorporate biomarkers from research settings into clinical practice, and opportunities to advance the field. This Proceedings of a Workshop summarizes the presentations and discussions from the event.", url = "https://nap.nationalacademies.org/catalog/26932/biomarkers-for-traumatic-brain-injury-proceedings-of-a-workshop", year = 2023, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "LeighAnne Olsen and J. Michael McGinnis", title = "Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary", isbn = "978-0-309-11988-7", abstract = "Recent scientific and technological advances have accelerated our understanding of the causes of disease development and progression, and resulted in innovative treatments and therapies. Ongoing work to elucidate the effects of individual genetic variation on patient outcomes suggests the rapid pace of discovery in the biomedical sciences will only accelerate. However, these advances belie an important and increasing shortfall between the expansion in therapy and treatment options and knowledge about how these interventions might be applied appropriately to individual patients. The impressive gains made in Americans' health over the past decades provide only a preview of what might be possible when data on treatment effects and patient outcomes are systematically captured and used to evaluate their effectiveness. Needed for progress are advances as dramatic as those experienced in biomedicine in our approach to assessing clinical effectiveness. \n\nIn the emerging era of tailored treatments and rapidly evolving practice, ensuring the translation of scientific discovery into improved health outcomes requires a new approach to clinical evaluation. A paradigm that supports a continual learning process about what works best for individual patients will not only take advantage of the rigor of trials, but also incorporate other methods that might bring insights relevant to clinical care and endeavor to match the right method to the question at hand. \n\nThe Institute of Medicine Roundtable on Value & Science-Driven Health Care's vision for a learning healthcare system, in which evidence is applied and generated as a natural course of care, is premised on the development of a research capacity that is structured to provide timely and accurate evidence relevant to the clinical decisions faced by patients and providers. As part of the Roundtable's Learning Healthcare System series of workshops, clinical researchers, academics, and policy makers gathered for the workshop Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches. Participants explored cutting-edge research designs and methods and discussed strategies for development of a research paradigm to better accommodate the diverse array of emerging data resources, study designs, tools, and techniques. Presentations and discussions are summarized in this volume.", url = "https://nap.nationalacademies.org/catalog/12197/redesigning-the-clinical-effectiveness-research-paradigm-innovation-and-practice-based", year = 2010, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Erin Balogh and Sharyl J. Nass", title = "Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop", isbn = "978-0-309-49086-3", abstract = "In recent years, significant progress has been made in the clinical development and use of various types of cancer immunotherapy, all of which rely on the immune system to fight cancer. The majority of new cancer drug applications submitted to the Food and Drug Administration (FDA) are for immunotherapies or combinations involving immunotherapies. One type of immunotherapy is an immune checkpoint inhibitor. Cells in the human body have proteins that regulate the immune system response to foreign invaders (e.g., cancer cells, microorganisms). However, cancer cells can coopt these \u201ccheckpoint\u201d proteins and thwart the immune system\u2019s ability to recognize and attack cancer cells. To help promote an immune response to cancer, researchers have developed immune checkpoint inhibitors that enable T-cells to recognize cancer cells as foreign and to prevent deactivation of an immune system response. \n\nTo examine the challenges and opportunities to develop combination cancer therapies that include immune checkpoint inhibitors, the National Cancer Policy Forum held a workshop on July 16\u201317, 2018, in Washington, DC. This workshop convened stakeholders with a broad range of expertise, including cancer researchers, clinicians, patient advocates, and representatives from industry, academia, and government. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/25405/advancing-progress-in-the-development-of-combination-cancer-therapies-with-immune-checkpoint-inhibitors", year = 2019, publisher = "The National Academies Press", address = "Washington, DC" }