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"Combined with the more traditional employer occupational safety and health protection activities are newer employment-based programs to promote better health through helping workers quit smoking, lose weight, reduce stress, or exercise more regularly. In support of these efforts, some employers have made changes in their policies and facilities to support physical activity and healthier eating, and some employers connect with community resources for health education, health fairs, and other services. This diverse array of activities most typically has been planned, managed, and assessed - to the extent they exist in the workplace at all - by different, often uncoordinated departments within the business entity. Some employers have reconceptualized their safety, prevention, and promotion initiatives and attempted to bring them together into a coherent whole. The National Institute for Occupational Safety and Health (NIOSH) has supported this integration, defining Total Worker Health as "a strategy integrating occupational safety and health protection with health promotion to prevent worker injury and illness and to advance health and well-being." In May 2014, with support from NIOSH, the Institute of Medicine organized a workshop on Total Worker Health. Rather than a review of published literature, this workshop sought input from a wide variety of on-the-ground stakeholders regarding their experiences with integrating occupational safety and health protection with health promotion in the workplace. Promising and Best Practices in Total Worker Health is the summary of the discussions and presentations of the event. This report identifies prevalent and best practices in programs that integrate occupational safety and health protection with health promotion in small, medium, and large workplaces; employer and employee associations; academia; government agencies; and other stakeholder groups."--

Industrial hygienex. --- Occupational health services. --- Employee health promotion. --- Incentives in industry.

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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 measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop"--

Evidence-based medicine --- Data processing

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"Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle"--

Communication -- Congresses. --- Risk assessment -- Congresses. --- Pharmaceutical policy --- Drugs --- Industry --- Risk --- Risk Management --- Chemicals and Drugs --- Publication Formats --- Information Science --- Behavior --- Epidemiologic Measurements --- Publication Characteristics --- Organization and Administration --- Probability --- Behavior and Behavior Mechanisms --- Public Health --- Technology, Industry, and Agriculture --- Health Services Administration --- Environment and Public Health --- Statistics as Topic --- Technology, Industry, Agriculture --- Psychiatry and Psychology --- Health Care Evaluation Mechanisms --- Epidemiologic Methods --- Health Care --- Quality of Health Care --- Investigative Techniques --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Health Care Quality, Access, and Evaluation --- Congresses --- Pharmaceutical Preparations --- Risk Assessment --- Communication --- Drug Industry --- Engineering & Applied Sciences --- Technology - General --- Decision making --- Law and legislation --- Risk assessment --- Government policy --- Testing

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"Compared with other disease areas, central nervous system (CNS) disorders have had the highest failure rate for new compounds in advanced clinical trials. Most CNS drugs fail because of efficacy, and the core issue underlying these problems is a poor understanding of disease biology. Concern about the poor productivity in neuroscience drug development has gained intensity over the past decade, amplified by a retraction in investment from the pharmaceutical industry. This retreat by industry has been fueled by the high failure rate of compounds in advanced clinical trials for nervous system disorders. In response to the de-emphasis of CNS disorders in therapeutic development relative to other disease areas such as cancer, metabolism, and autoimmunity, the National Academies of Sciences, Engineering, and Medicine initiated a series of workshops in 2012 to address the challenges that have slowed drug development for nervous system disorders. Motivated by the notion that advances in genetics and other new technologies are beginning to bring forth new molecular targets and identify new biomarkers, the Academies hosted the third workshop in this series in September 2016. Participants discussed opportunities to accelerate early stages of drug development for nervous system disorders in the absence of animal models that reflect disease and predict efficacy. This publication summarizes the presentations and discussions from the workshop"--

Nervous system --- Diseases

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"Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. Novel clinical trial designs that enroll participants based on their genetics represent a potentially disruptive change that could improve patient outcomes, reduce costs associated with drug development, and further realize the goals of precision medicine. On March 8, 2017, the Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine hosted the workshop Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development. Participants examined successes, challenges, and possible best practices for effectively using genetic information in the design and implementation of clinical trials to support the development of precision medicines, including exploring the potential advantages and disadvantages of such trials across a variety of disease areas. This publication summarizes the presentations and discussions from the workshop"--Publisher's description.

Drug development --- Personalized medicine --- Pharmacogenetics --- Precision medicine