Potential Risks and Benefits of Gain-of-Function Research

Potential Risks and Benefits of Gain-of-Function Research

Author: National Research Council

Publisher: National Academies Press

Published: 2015-04-13

Total Pages: 131

ISBN-13: 0309367867

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On October 17, 2014, spurred by incidents at U.S. government laboratories that raised serious biosafety concerns, the United States government launched a one-year deliberative process to address the continuing controversy surrounding so-called "gain-of-function" (GOF) research on respiratory pathogens with pandemic potential. The gain of function controversy began in late 2011 with the question of whether to publish the results of two experiments involving H5N1 avian influenza and continued to focus on certain research with highly pathogenic avian influenza over the next three years. The heart of the U.S. process is an evaluation of the potential risks and benefits of certain types of GOF experiments with influenza, SARS, and MERS viruses that would inform the development and adoption of a new U.S. Government policy governing the funding and conduct of GOF research. Potential Risks and Benefits of Gain-of-Function Research is the summary of a two-day public symposia on GOF research. Convened in December 2014 by the Institute of Medicine and the National Research Council, the main focus of this event was to discuss principles important for, and key considerations in, the design of risk and benefit assessments of GOF research. Participants examined the underlying scientific and technical questions that are the source of current discussion and debate over GOF research involving pathogens with pandemic potential. This report is a record of the presentations and discussion of the meeting.


The Benefit/Risk Ratio

The Benefit/Risk Ratio

Author: Hans C. Korting

Publisher: CRC Press

Published: 1998-07-24

Total Pages: 402

ISBN-13: 9781439805916

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The use of drugs as remedies for various types of diseases has a long tradition; however, it has only been recently recognized that the value of any given compound must be evaluated in light of its benefit to risk ratio. When prescribing drugs, physicians must look at the big picture of the drug's benefits in relation to its side effects and possib


Risk-benefit Analysis

Risk-benefit Analysis

Author: Richard Wilson

Publisher:

Published: 2001

Total Pages: 396

ISBN-13:

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Over the centuries, mankind has slowly reduced the risks and hazards that even as recently as a century ago kept life expectancy to a mere 45 years. Our average lifespan has improved to 77 years by remarkable progress in public health and safety. But with this improvement has come a demand for greater efforts to improve both life expectancy and the quality of life. The first edition of this book, published in 1982, was a pioneer in the development of logical, yet simple, analytic tools for discussion of the risks which we all face. This new edition, revised, expanded, and illustrated in detail, should be of value both to professionals in the field and to those who wish to understand these vital issues.


Pharmacoepidemiology

Pharmacoepidemiology

Author: Brian L. Strom

Publisher: John Wiley & Sons

Published: 2019-12-16

Total Pages: 1220

ISBN-13: 1119413419

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Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.


Benefit-Risk Assessment in Pharmaceutical Research and Development

Benefit-Risk Assessment in Pharmaceutical Research and Development

Author: Andreas Sashegyi

Publisher: CRC Press

Published: 2013-11-27

Total Pages: 216

ISBN-13: 143986795X

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Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations rele


Benefit-Risk Assessment of Medicines

Benefit-Risk Assessment of Medicines

Author: James Leong

Publisher: Adis

Published: 2016-10-13

Total Pages: 0

ISBN-13: 9783319367675

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This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.


Cost-Benefit Analysis of Environmental Health Interventions

Cost-Benefit Analysis of Environmental Health Interventions

Author: Carla Guerriero

Publisher: Academic Press

Published: 2019-12-02

Total Pages: 0

ISBN-13: 9780128128855

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Cost-benefit Analysis of Environmental Health Interventions clearly articulates the core principles and fundamental methodologies underpinning the modern economic assessment of environmental intervention on human health. Taking a practical approach, the book provides a step-by-step approach to assigning a monetary value to the health benefits and disbenefits arising from interventions, using environmental information and epidemiological evidence. It summarizes environmental risk factors and explores how to interpret and understand epidemiological data using concentration-response, exposure-response or dose-response techniques, explaining the environmental interventions available for each environmental risk factor. It evaluates in detail two of the most challenging stages of Cost-Benefit Analysis in 'discounting' and 'accounting for uncertainty'. Further chapters describe how to analyze and critique results, evaluate potential alternatives to Cost-Benefit Analysis, and on how to engage with stakeholders to communicate the results of Cost-Benefit Analysis. The book includes a detailed case study how to conduct a Cost-Benefit Analysis. It is supported by an online website providing solution files and detailing the design of models using Excel.


Decision Science and Social Risk Management

Decision Science and Social Risk Management

Author: M.W Merkhofer

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 344

ISBN-13: 9400946988

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Economists, decision analysts, management scientists, and others have long argued that government should take a more scientific approach to decision making. Pointing to various theories for prescribing and rational izing choices, they have maintained that social goals could be achieved more effectively and at lower costs if government decisions were routinely subjected to analysis. Now, government policy makers are putting decision science to the test. Recent government actions encourage and in some cases require government decisions to be evaluated using formally defined principles 01' rationality. Will decision science pass tbis test? The answer depends on whether analysts can quickly and successfully translate their theories into practical approaches and whether these approaches promote the solution of the complex, highly uncertain, and politically sensitive problems that are of greatest concern to government decision makers. The future of decision science, perhaps even the nation's well-being, depends on the outcome. A major difficulty for the analysts who are being called upon by government to apply decision-aiding approaches is that decision science has not yet evolved a universally accepted methodology for analyzing social decisions involving risk. Numerous approaches have been proposed, including variations of cost-benefit analysis, decision analysis, and applied social welfare theory. Each of these, however, has its limitations and deficiencies and none has a proven track record for application to govern ment decisions involving risk. Cost-benefit approaches have been exten sively applied by the government, but most applications have been for decisions that were largely risk-free.


International Ethical Guidelines for Health-Related Research Involving Humans

International Ethical Guidelines for Health-Related Research Involving Humans

Author: Council for International Organizations of Medical Sciences (CIOMS)

Publisher: World Health Organization

Published: 2017-01-31

Total Pages: 0

ISBN-13: 9789290360889

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"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.