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The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measur...

Countering violent extremism consists of various prevention and intervention approaches to increase the resilience of communities and individuals to radicalization toward violent extremism, to provide nonviolent avenues for expressing grievances, and to educate communities about the threat of recruitment and radicalization to violence. To explore the application of health approaches in community-level strategies to countering violent extremism...

Both the Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) have responsibilities for evaluating and regulating respiratory protective devices ("respirators") for health care workers. Respirators protect the user from respiratory hazards by either removing contaminants from the air (air-purifying respirators) or by supplying clean air from another source (air-supplying respirators). Respira...

This is the fourth in a series of five letter reports that provide an independent review of the more than 30 evidence reports that NASA has compiled on human health risks for long-duration and exploration spaceflights.This letter report reviews eight evidence reports and examines the quality of the evidence, analysis, and overall construction of each report, identifies existing gaps in report content, and provides suggestions for additional so...

In February 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to explore options for expanding the Substance Abuse and Mental Health Services Administration's (SAMHSA) behavioral health data collections to include measures of recovery from substance use and mental disorder. Participants discussed options for collecting data and producing estimates of recovery from substance use and mental disorders, including ...

The Department of Homeland Security's (DHS's) BioWatch program aims to provide an early indication of an aerosolized biological weapon attack. The first generation of BioWatch air samplers were deployed in 2003. The current version of this technology, referred to as Generation 2 (Gen-2), uses daily manual collection and testing of air filters from each monitor, a process that can take 12 to 36 hours to detect the presence of biological pathoge...

The Workshop on Integrating New Measures of Trauma into the Substance Abuse and Mental Health Services Administration's (SAMHSA) Data Collection Programs, held in Washington, D.C. in December 2015, was organized as part of an effort to assist SAMHSA and the Office of the Assistant Secretary for Planning and Evaluation of the U.S. Department of Health and Human Services in their responsibilities to expand the collection of behavioral health dat...

The field of endeavors known as 'regulatory science' has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicatin...

Implementation research is designed to 'generate insights and knowledge about implementation processes, barriers, facilitators, and strategies', explained Brian Mittman, a research scientist at Kaiser Permanente Research. Workshop speakers examined issues that pertain to genomic medicine, gathering evidence during implementation, and using genomic medicine to improve population health."--Page 3.

The process of discovering and developing a new drug or therapy is extremely costly and time consuming, and recently, it has been estimated that the creation of a new medicine costs on average more than $2 billion and takes 10 years to reach patients. The challenges associated with bringing new medicines to market have led many pharmaceutical companies to seek out innovative methods for streamlining their drug discovery research. One way to in...

Large catastrophic events, or rare acute events, may cause situations in which a local jurisdiction's medicines and medical supplies are not sufficient to provide care to the population it serves. In these cases of natural or engineered disasters, such as a terrorist attack, influenza pandemic, or earthquake, state or local authorities can request that the federal government provide assets from the Strategic National Stockpile to augment the s...

Introduction -- Hearing loss: extent, impact, and research needs -- Hearing health care services: improving access and quality -- Hearing technologies: expanding options -- Improving affordability of services and technologies -- Engaging a wider community: awareness, education, and support -- Opportunities for action -- Appendix A: Meeting agendas -- Appendix B: Committee biographies.

Multimodal therapy approaches that combine interventions aimed at different aspects of disease are emerging as potential--and perhaps essential--ways 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...

On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally assoc...