Workshop
Sharing knowledge is what drives scientific progress - each new advance or innovation in biomedical research builds on previous observations. However, for experimental findings to be broadly accepted as credible by the scientific community, they must be verified by other researchers. An essential step is for researchers to report their findings in a manner that is understandable to others in the scientific community and provide sufficient information for others to validate the original results and build on them. In recent years, concern has been growing over a number of studies that have failed to replicate previous results and evidence from larger meta-analyses, which have pointed to the lack of reproducibility in biomedical research.
On September 25 and 26, 2019, the National Academies of Science, Engineering, and Medicine hosted a public workshop in Washington, DC, to discuss the current state of transparency in the reporting of preclinical biomedical research and to explore opportunities for harmonizing reporting guidelines across journals and funding agencies. Convened jointly by the Forum on Drug Discovery, Development, and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Genomics and Precision Health, the workshop primarily focused on transparent reporting in preclinical research, but also considered lessons learned and best practices from clinical research reporting. This publication summarizes the presentation and discussion of the workshop.
142 pages
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ISBN Paperback: 0-309-66349-0
ISBN Ebook: 0-309-66350-4
DOI:
https://doi.org/10.17226/25627
National Academies of Sciences, Engineering, and Medicine. 2020. Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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Research and innovation in the life sciences is driving rapid growth in agriculture, biomedical science, information science and computing, energy, and other sectors of the U.S. economy. This economic activity, conceptually referred to as the bioeconomy, presents many opportunities to create jobs, improve the quality of life, and continue to drive economic growth. While the United States has been a leader in advancements in the biological sciences, other countries are also actively investing in and expanding their capabilities in this area. Maintaining competitiveness in the bioeconomy is key to maintaining the economic health and security of the United States and other nations.
Safeguarding the Bioeconomy evaluates preexisting and potential approaches for assessing the value of the bioeconomy and identifies intangible assets not sufficiently captured or that are missing from U.S. assessments. This study considers strategies for safeguarding and sustaining the economic activity driven by research and innovation in the life sciences. It also presents ideas for horizon scanning mechanisms to identify new technologies, markets, and data sources that have the potential to drive future development of the bioeconomy.
392 pages
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ISBN Paperback: 0-309-49567-9
ISBN Ebook: 0-309-49568-7
DOI:
https://doi.org/10.17226/25525
National Academies of Sciences, Engineering, and Medicine. 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press.
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Workshop
To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24-25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
102 pages
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ISBN Paperback: 0-309-49848-1
ISBN Ebook: 0-309-49849-X
DOI:
https://doi.org/10.17226/25591
National Academies of Sciences, Engineering, and Medicine. 2020. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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Workshop
The Centers for Disease Control and Prevention estimates that approximately 40 million people in the United States suffer from a serious illness that limits their daily activities. These illnesses include heart and lung disease, cancer, diabetes, and Alzheimer's disease and other forms of dementia. However, significant disparities exist across different communities in the quality and access to care for these illnesses. Factors such as race, ethnicity, gender, geography, socioeconomic status, or insurance status exacerbate these complex disparities. It is critical to reevaluate the current models of care delivery across diverse communities and vulnerable populations.
On April 4, 2019, The National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate barriers, policy initiatives, and opportunities for improving access to and equity of care for people living with a serious illness. Discussions explored the current climate of health care and opportunities to improve access to care using organizational, community, patient and family, and clinician perspectives. This publication summarizes the discussions and presentations from the workshop.
106 pages
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ISBN Paperback: 0-309-49589-X
ISBN Ebook: 0-309-49590-3
DOI:
https://doi.org/10.17226/25530
National Academies of Sciences, Engineering, and Medicine. 2019. Improving Access to and Equity of Care for People with Serious Illness: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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Workshop
On April 23 and 24, 2019 the Forum on Neuroscience and Nervous System Disorders convened a workshop titled "Advancing Gene-Targeted Therapies for Central Nervous System Disorders" in Washington, DC. This public workshop brought together experts and key stakeholders from academia, government, industry, philanthropic foundations, and disease/patient-focused nonprofit organizations to explore approaches for advancing the development of gene-targeted therapies for central nervous system (CNS) disorders, and implications of developing these therapies. Participants explored lessons learned from both successful and unsuccessful clinical development programs; new knowledge about the genetic underpinnings of brain disorders; the current status and future potential of gene-targeted therapies for CNS disorders; challenges and potential solutions for translating preclinical findings to approved therapies; and patient and caregiver perspectives. They also discussed what will be needed to develop these therapies for common disorders such as Alzheimer's and Parkinson's disease, as well as neuropsychiatric and neurodevelopmental disorders such as schizophrenia and autism. The workshop included approaches that target both DNA and RNA, as well as gene products using viral vectors, antisense oligonucleotides, and RNA interference. This publication summarizes the presentations and discussion of the workshop.
92 pages
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ISBN Paperback: 0-309-49584-9
ISBN Ebook: 0-309-49585-7
DOI:
https://doi.org/10.17226/25529
National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Gene-Targeted Therapies for Central Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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Workshop
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.
On 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.
126 pages
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ISBN Paperback: 0-309-49488-5
ISBN Ebook: 0-309-49489-3
DOI:
https://doi.org/10.17226/25502
National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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Workshop_in_brief
On July 26, 2018, the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop featuring two panel sessions on evidence synthesis and grading. The purpose of this workshop was to gather and evaluate existing public health emergency preparedness and response research and to provide recommendations about future research possibilities and actions that could improve preparedness and response practices. This publication briefly summarizes the presentations and discussions from the workshop.
9 pages
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ISBN Ebook: 0-309-49526-1
DOI:
https://doi.org/10.17226/25510
National Academies of Sciences, Engineering, and Medicine. 2019. Methodologies for Evaluating and Grading Evidence: Considerations for Public Health Emergency Preparedness and Response: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press.
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Workshop
The United States is facing an opioid use disorder epidemic with opioid overdoses killing 47,000 people in the U.S. in 2017. The past three decades have witnessed a significant increase in the prescribing of opioids for pain, based on the belief that patients were being undertreated for their pain, coupled with a widespread misunderstanding of the addictive properties of opioids. This increase in prescribing of opioids also saw a parallel increase in addiction and overdose. In an effort to address this ongoing epidemic of opioid misuse, policy and regulatory changes have been enacted that have served to limit the availability of prescription opioids for pain management.
Overlooked amid the intense focus on efforts to end the opioid use disorder epidemic is the perspective of clinicians who are experiencing a significant amount of daily tension as opioid regulations and restrictions have limited their ability to treat the pain of their patients facing serious illness. Increased public and clinician scrutiny of opioid use has resulted in patients with serious illness facing stigma and other challenges when filling prescriptions for their pain medications or obtaining the prescription in the first place. Thus clinicians, patients, and their families are caught between the responses to the opioid use disorder epidemic and the need to manage pain related to serious illness.
The National Academies of Sciences, Engineering, and Medicine sponsored a workshop on November 29, 2018, to examine these unintended consequences of the responses to the opioid use disorder epidemic for patients, families, communities, and clinicians, and to consider potential policy opportunities to address them. This publication summarizes the presentations and discussions from the workshop.
104 pages
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ISBN Paperback: 0-309-49223-8
ISBN Ebook: 0-309-49224-6
DOI:
https://doi.org/10.17226/25435
National Academies of Sciences, Engineering, and Medicine. 2019. Pain Management for People with Serious Illness in the Context of the Opioid Use Disorder Epidemic: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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Over the past 15 years, the National Academies of Sciences, Engineering, and Medicine (the National Academies) have convened multiple committees of leading experts to address ethical challenges related to innovative and emerging biomedical technologies. After reviewing prior National Academies' reports, individual ethics principles and considerations were identified and grouped into sets of related considerations to establish guidelines for future studies.
Framework for Addressing Ethical Dimensions of Emerging and Innovative Biomedical Technologies provides a synopsis of principal ethical commitments and core values that characterize the National Academies' work in the domain of emerging biomedical technologies. This publication offers a synthesis of relevant National Academies' reports.
13 pages
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ISBN Ebook: 0-309-49463-X
DOI:
https://doi.org/10.17226/25491
National Academies of Sciences, Engineering, and Medicine. 2019. Framework for Addressing Ethical Dimensions of Emerging and Innovative Biomedical Technologies: A Synthesis of Relevant National Academies Reports. Washington, DC: The National Academies Press.
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Workshop
The emerging multidisciplinary field of regenerative engineering is devoted to the repair, regeneration, and replacement of damaged tissues or organs in the body. To accomplish this it uses a combination of principles and technologies from disciplines such as advanced materials science, developmental and stem cell biology, immunology, physics, and clinical translation. The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products. Furthermore, each patient recipient, tissue donor, and product application is unique, meaning that the field faces complexities in the development of safe and effective new products and therapies which are not faced by developers of more conventional therapies. Understanding the many sources of variability can help reduce this variability and ensure consistent results.
The Forum on Regenerative Medicine hosted a public workshop on October 18, 2018, in Washington, DC, to explore the various factors that must be taken into account in order to develop successful regenerative engineering products. Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product to improve patient outcomes. This publication summarizes the presentation and discussion of the workshop.
132 pages
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ISBN Paperback: 0-309-48909-1
ISBN Ebook: 0-309-48910-5
DOI:
https://doi.org/10.17226/25371
National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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The National Academies of Sciences, Engineering, and Medicine held a workshop on August 22-23, 2018, in Washington, DC, to explore medical and public health preparedness for a nuclear incident. The event brought together experts from government, nongovernmental organizations, academia, and the private sector to explore current assumptions behind the status of medical and public health preparedness for a nuclear incident, examine potential changes in these assumptions in light of increasing concerns about the use of nuclear warfare, and discuss challenges and opportunities for capacity building in the current threat environment. This publication summarizes the presentations and discussions from the workshop.
210 pages
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ISBN Paperback: 0-309-48914-8
ISBN Ebook: 0-309-48915-6
DOI:
https://doi.org/10.17226/25372
National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Medical and Public Health Preparedness for a Nuclear Incident: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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Pain is a leading cause of disability globally. The dramatic increase in opioid prescriptions within the past decade in the United States has contributed to the opioid epidemic the country currently faces, magnifying the need for longer term solutions to treat pain. The substantial burden of pain and the ongoing opioid crisis have attracted increased attention in medical and public policy communities, resulting in a revolution in thinking about how pain is managed. This new thinking acknowledges the complexity and biopsychosocial nature of the pain experience and the need for multifaceted pain management approaches with both pharmacological and nonpharmacological therapies.
The magnitude and urgency of the twin problems of chronic pain and opioid addiction, combined with the changing landscape of pain management, prompted the National Academies of Sciences, Engineering, and Medicine to convene a workshop on December 4-5, 2018, in Washington, DC. The workshop brought together a diverse group of stakeholders to discuss the current status of nonpharmacological approaches to pain management, gaps, and future directions. This publication summarizes the presentations and discussions from the workshop.
138 pages
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ISBN Paperback: 0-309-49091-X
ISBN Ebook: 0-309-49092-8
DOI:
https://doi.org/10.17226/25406
National Academies of Sciences, Engineering, and Medicine. 2019. The Role of Nonpharmacological Approaches to Pain Management: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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Workshop_in_brief
On October 24, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Artificial Intelligence Applications for Older Adults and People with Disabilities: Balancing Safety and Autonomy. This workshop examined the state of the art and knowledge about artificial intelligence and explored its potential to foster a balance of safety and autonomy for older adults and people with disabilities who strive to live as independently as possible. This publication summarizes the presentations and discussions from the workshop.
9 pages
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ISBN Ebook: 0-309-49202-5
DOI:
https://doi.org/10.17226/25427
National Academies of Sciences, Engineering, and Medicine. 2019. Artificial Intelligence Applications for Older Adults and People with Disabilities: Balancing Safety and Autonomy: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press.
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The opioid crisis in the United States has come about because of excessive use of these drugs for both legal and illicit purposes and unprecedented levels of consequent opioid use disorder (OUD). More than 2 million people in the United States are estimated to have OUD, which is caused by prolonged use of prescription opioids, heroin, or other illicit opioids. OUD is a life-threatening condition associated with a 20-fold greater risk of early death due to overdose, infectious diseases, trauma, and suicide. Mortality related to OUD continues to escalate as this public health crisis gathers momentum across the country, with opioid overdoses killing more than 47,000 people in 2017 in the United States. Efforts to date have made no real headway in stemming this crisis, in large part because tools that already exist—like evidence-based medications—are not being deployed to maximum impact.
To support the dissemination of accurate patient-focused information about treatments for addiction, and to help provide scientific solutions to the current opioid crisis, this report studies the evidence base on medication assisted treatment (MAT) for OUD. It examines available evidence on the range of parameters and circumstances in which MAT can be effectively delivered and identifies additional research needed.
174 pages
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ISBN Paperback: 0-309-48648-3
ISBN Ebook: 0-309-48649-1
DOI:
https://doi.org/10.17226/25310
National Academies of Sciences, Engineering, and Medicine. 2019. Medications for Opioid Use Disorder Save Lives. Washington, DC: The National Academies Press.
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Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making.
To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.
230 pages
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ISBN Paperback: 0-309-48829-X
ISBN Ebook: 0-309-48830-3
DOI:
https://doi.org/10.17226/25352
National Academies of Sciences, Engineering, and Medicine. 2019. Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series. Washington, DC: The National Academies Press.
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To examine the promise, concerns, and challenges related to neuroscience research using genetically modified nonhuman primates, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop on October 4, 2018, bringing together an international group of experts and stakeholders representing academia, industry, laboratory animal management, disease-focused foundations, and federal agencies. The workshop was designed to explore the current state and future promise of research using genetically modified nonhuman primate models of disease to understand the complex functions of the brain that control behavior, movement, and cognition in both health and disease states. This publication summarizes the presentations and discussions from the workshop.
90 pages
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ISBN Paperback: 0-309-48873-7
ISBN Ebook: 0-309-48874-5
DOI:
https://doi.org/10.17226/25362
National Academies of Sciences, Engineering, and Medicine. 2019. Transgenic Neuroscience Research: Exploring the Scientific Opportunities Afforded by New Nonhuman Primate Models: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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A growing body of research indicates that social determinants of health have a significant impact on health care utilization and outcomes. Researchers and policymakers in the United States have spent decades exploring and discussing approaches to integrating health care and social services. While no nation has a truly integrated system, many other industrialized nations invest more heavily in social services than the United States, and are more effective in integrating these services with health care. Integrating health care and social services, such as accessible housing, meals and nutrition services, transportation, and caregiver training, is particularly important for those facing serious illness who typically encounter multiple chronic conditions, pain and other symptoms, functional dependency, frailty, and significant family caregiver needs.
In an effort to better understand and facilitate discussions about the challenges and opportunities related to integrating health care and social services for people with serious illness, the National Academies of Sciences, Engineering, and Medicine held a full-day public workshop on July 19, 2018 in Washington, DC. The workshop featured a broad range of experts and stakeholders including researchers, policy analysts, patient and family caregiving advocates, and representatives of federal agencies. This publication summarizes the presentations and discussions from the workshop.
98 pages
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ISBN Paperback: 0-309-48816-8
ISBN Ebook: 0-309-48817-6
DOI:
https://doi.org/10.17226/25350
National Academies of Sciences, Engineering, and Medicine. 2019. Integrating Health Care and Social Services for People with Serious Illness: Proceedings of a Workshop. Washington, DC: The National Academies Press.
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Protecting the health and safety of health care workers is vital to the health of each of us. Preparing for and responding to a future influenza pandemic or to a sustained outbreak of an airborne transmissible disease requires a high-level commitment to respiratory protection for health care workers across the wide range of settings in which they work and the jobs that they perform. Keeping health care workers healthy is an ethical commitment both in terms of addressing the occupational risks faced by health care workers and of providing for the continuity of patient care and services needed to maintain the health of individuals and communities.
During a public health emergency, challenges will arise concerning the availability of respiratory protective devices (i.e., respirators). Reusable respirators (specifically, reusable half-facepiece elastomeric respirators) are the standard respiratory protection device used in many industries, and they provide an option for use in health care that has to date not been fully explored. The durability and reusability of elastomeric respirators make them desirable for stockpiling for emergencies, where the need for large volumes of respirators can be anticipated. However, they are used infrequently in health care.
Reusable Elastomeric Respirators in Health Care explores the potential for the use of elastomeric respirators in the U.S. health care system with a focus on the economic, policy, and implementation challenges and opportunities. This report examines the practicability of elastomeric use in health care on a routine basis and during an influenza pandemic or other large aerosol-transmissible outbreak, when demand for respiratory protective devices by U.S. health care personnel may be larger than domestic supplies. The report also addresses the issues regarding emergency stockpile management of elastomeric respiratory protective devices.
226 pages
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6 x 9
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ISBN Paperback: 0-309-48515-0
ISBN Ebook: 0-309-48516-9
DOI:
https://doi.org/10.17226/25275
National Academies of Sciences, Engineering, and Medicine. 2019. Reusable Elastomeric Respirators in Health Care: Considerations for Routine and Surge Use. Washington, DC: The National Academies Press.
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