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The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care, new approaches are enabling the collection of data in real-world settings, and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by ...

The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensur...

Advance Care Planning(ACP)has long been a staple of caring for people with serious illness. Over its history, it has been defined in different ways. Clinicians, researchers, patients, and the public have developed a variety of perspectives about the many aspects of ACP, ranging from the definition to the timing, goals, outcomes, and value of ACP. To better understand the challenges and opportunities for ACP, acknowledge and highlight divergent...

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 ...

To explore issues related to the effects of disasters on children and youth and lessons learned from experiences during previous disasters, the virtual workshop From Hurricane Katrina to Paradise Wildfires, Exploring Themes in Disaster Human Services was convened on July 22 and 23, 2020, by the National Academies of Sciences, Engineering, and Medicine. The workshop was designed to focus on families engaged with federal, state or local supporti...

There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years and over. Because older adults are vastly underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, and are ...

Accumulating evidence gathered over the past three decades has demonstrated a biological basis for differences between men and women with respect to clinical features and treatment responses to several neuropsychiatric, neurodevelopmental, and neurodegenerative disorders. Dramatic sex differences have also been identified in the brain transcriptomes of individuals with multiple brain disorders, including depression, posttraumatic stress disord...

Regenerative medicine products, which are intended to repair or replace damaged cells or tissues in the body, include a range of therapeutic approaches such as cell- and gene-based therapies, engineered tissues, and non-biologic constructs. The current approach to characterizing the quality of a regenerative medicine product and the manufacturing process often involves measuring as many endpoints as possible, but this approach has proved to be...

To address approaches to the respirator approval process in the current landscape for both occupational and non-occupational use of respirators, the National Academies of Sciences, Engineering, and Medicine's Standing Committee on Personal Protective Equipment for Workplace Safety and Health convened a virtual workshop, Current Issues in the Assessment of Respiratory Protective Devices: Nontraditional Workers and Public Use on August 4-5, 2020...

Behavioral health conditions, which include mental health and substance use disorders, affect approximately 20 percent of Americans. Of those with a substance use disorder, approximately 60 percent also have a mental health disorder. As many as 80 percent of patients with behavioral health conditions seek treatment in emergency rooms and primary care clinics, and between 60 and 70 percent of them are discharged without receiving behavioral hea...

In the wake of a large-scale disaster, from the initial devastation through the long tail of recovery, protecting the health and well-being of the affected individuals and communities is paramount. Accurate and timely information about mortality and significant morbidity related to the disaster are the cornerstone of the efforts of the disaster management enterprise to save lives and prevent further health impacts. Conversely, failure to accur...

On March 24, 2020, a 1-day public workshop titled The Role of Digital Health Technologies in Drug Development was convened by the National Academies of Sciences, Engineering, and Medicine. This workshop builds on prior efforts to explore how virtual clinical trials facilitated by digital health technologies (DHTs) might change the landscape of drug development. To explore the challenges and opportunities in using DHTs for improving the probabi...

The U.S. Food and Drug Administration (FDA) has approved dozens of hormone therapy products for men and women, including estrogen, progesterone, testosterone, and related compounds. These products have been reviewed for safety and efficacy and are indicated for treatment of symptoms resulting from hormonal changes associated with menopause or other endocrine-based disorders. In recent decades, an increasing number of health care providers and ...

On February 26, 2020, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 1-day public workshop in Washington, DC, to examine current and emerging bioethical issues that might arise in the context of biomedical research and to consider research topics in bioethics that could benefit from further attention. The scope of bioethical issues in research is broad, but this workshop focused on...

For many years, laboratory dogs have served as important animal models for biomedical research that has advanced human health. Conducted at the request of the U.S. Department of Veterans Affairs (VA), this report assesses whether laboratory dogs are or will continue to be necessary for biomedical research related to the VA's mission. The report concludes that using laboratory dogs in research at the VA is scientifically necessary for only a fe...

Consumer genomics, encompassing both direct-to-consumer applications (i.e., genetic testing that is accessed by a consumer directly from a commercial company apart from a health care provider) and consumer-driven genetic testing (i.e., genetic testing ordered by a health care provider in response to an informed patient request), has evolved considerably over the past decade, moving from more personal utility-focused applications outside of tra...

Participants in this workshop, which took place on January 17, 2020, considered whether embryo model systems - especially those that use nonhuman primate cells - can be used to predict the function of systems made with human cells. Presentations provided an overview of the current state of the science of in vitro development of human trophoblast--The National Academies of Sciences, Engineering, Medicine website (viewed September 18, 2020)

Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. ...

The United States faces a significantly aging population as well as a growing share of the population that is living longer with multiple chronic conditions. To provide high-quality care to people of all ages living with serious illness, it is critical that the nation develop an adequately trained and prepared workforce consisting of a range of professionals, including physicians, nurses, social workers, direct care workers, and chaplains. To ...

In 2009 the Institute of Medicine (IOM) began to assess the need for better-defined medical and public health crisis standards of care (CSC) for catastrophic disasters and public health emergencies. Over the next 10 years, the IOM defined templates for those stakeholders responsible for integrated CSC planning and implementation, created a tool kit with guidance on indicators and triggers, provided a discussion kit for stakeholders to use with...