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Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients"--The National Academies of Sciences, Engineering, Medicine website (viewed September 17, 2020)

Behavioral health and substance use disorders affect approximately 20 percent of the U.S. population. Of those with a substance use disorder, approximately 60 percent also have a mental health disorder. Together, these disorders account for a substantial burden of disability, have been associated with an increased risk of morbidity and mortality from other chronic illnesses, and can be risk factors for incarceration, homelessness, and death by...

The cloud model of data sharing has led to a vast increase in the quantity and complexity of data and expanded access to these data, which has attracted many more researchers, enabled multi-national neuroscience collaborations, and facilitated the development of many new tools. Yet, the cloud model has also produced new challenges related to data storage, organization, and protection. Merely switching the technical infrastructure from local re...

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...

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-targe...

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, et...

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 t...

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 ...

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 inc...

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 chan...

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...

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 ...

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 ...

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 val...

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 mor...

The critical importance of using mobile technology is clear to anyone in the health professions, particularly those who treat people with central nervous system (CNS) disorders. To explore current developments and opportunities for using mobile technology to advance research and treatment of CNS disorders, the National Academies' Forum on Neuroscience and Nervous System Disorders hosted a workshop in June 5-6, 2018. This publication summarizes...

Genomic medicine is defined as the routine use of genomic information about an individual as part of his or her clinical care as well as the health outcomes and policy implications of that clinical use. It is one approach that has the potential to improve the quality of health care by allowing practitioners to tailor prevention, diagnostic, and treatment strategies to individual patients. In recent years, research breakthroughs, technological ...

Millions of Americans of all ages face the challenge of living with serious illnesses such as advanced cancer, heart, or lung disease. Many people with serious illness are increasingly cared for in community settings. While the number of community-based programs to provide care for those with serious illness has grown significantly, the quality of care provided is not consistent across geographic locations or care settings. Care for the seriou...

Disasters tend to cross political, jurisdictional, functional, and geographic boundaries. As a result, disasters often require responses from multiple levels of government and multiple organizations in the public and private sectors. This means that public and private organizations that normally operate independently must work together to mount an effective disaster response. To identify and understand approaches to aligning health care system...

The Centers for Disease Control and Prevention (CDC) established the Strategic National Stockpile (SNS) with a focus on procuring and managing medical countermeasures (MCM) designed to address chemical, biological, radiological, and nuclear events and attacks by weapons of mass destruction. The stockpile is a repository of antibiotics, chemical antidotes, antitoxins, vaccines, antiviral drugs, and other medical material organized to respond to...