Risk Vs Benefit

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Publisher : National Academies Press
Page : 292 pages
File Size : 54,7 Mb
Release : 2012-07-30
Category : Medical
ISBN : 9780309218160

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Ethical and Scientific Issues in Studying the Safety of Approved Drugs by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs Pdf

An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.

Author : Graeme Laurie,Edward Dove,Agomoni Ganguli-Mitra,Catriona McMillan,Emily Postan,Nayha Sethi,Annie Sorbie
Publisher : Unknown
Page : 444 pages
File Size : 42,7 Mb
Release : 2021-06-09
Category : Law
ISBN : 9781108576093

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The Cambridge Handbook of Health Research Regulation by Graeme Laurie,Edward Dove,Agomoni Ganguli-Mitra,Catriona McMillan,Emily Postan,Nayha Sethi,Annie Sorbie Pdf

The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.

Author : Steven Woloshin,Lisa Miriam Schwartz,Lisa M. Schwartz,H. Gilbert Welch
Publisher : Univ of California Press
Page : 154 pages
File Size : 47,5 Mb
Release : 2008-11-30
Category : Medical
ISBN : 9780520252226

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Know Your Chances by Steven Woloshin,Lisa Miriam Schwartz,Lisa M. Schwartz,H. Gilbert Welch Pdf

Understanding risk -- Putting risk in perspective -- Risk charts : a way to get perspective -- Judging the benefit of a health intervention -- Not all benefits are equal : understand the outcome -- Consider the downsides -- Do the benefits outweight the downsides? -- Beware of exaggerated importance -- Beware of exaggerated certainty -- Who's behind the numbers?

Author : National Research Council,Institute of Medicine,Board on Health Sciences Policy,Policy and Global Affairs,Committee on Science, Technology, and Law,Division on Earth and Life Studies,Board on Life Sciences
Publisher : National Academies Press
Page : 140 pages
File Size : 43,8 Mb
Release : 2015-04-13
Category : Science
ISBN : 9780309367868

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Potential Risks and Benefits of Gain-of-Function Research by National Research Council,Institute of Medicine,Board on Health Sciences Policy,Policy and Global Affairs,Committee on Science, Technology, and Law,Division on Earth and Life Studies,Board on Life Sciences Pdf

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.

Author : Les Irwig
Publisher : Judy Irwig
Page : 255 pages
File Size : 55,6 Mb
Release : 2008
Category : Health & Fitness
ISBN : 9781905140176

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Smart Health Choices by Les Irwig Pdf

Every day we make decisions about our health - some big and some small. What we eat, how we live and even where we live can affect our health. But how can we be sure that the advice we are given about these important matters is right for us? This book will provide you with the right tools for assessing health advice.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 55,9 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

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Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Author : Sandu, Antonio,Frunza, Ana,Unguru, Elena
Publisher : IGI Global
Page : 373 pages
File Size : 40,5 Mb
Release : 2018-11-16
Category : Reference
ISBN : 9781522563112

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Ethics in Research Practice and Innovation by Sandu, Antonio,Frunza, Ana,Unguru, Elena Pdf

A particularly important component of any research project is its ethical dimensions which can refer to varied categories of practice – from the protection of human subjects involved in medical and social research to the publication of results research. More recently, with the estimation of the possible consequences of the implementation of technology, it is important for today’s researchers to address the standards of scientific practice and avoid unethical behavior. Ethics in Research Practice and Innovation is an essential reference source that discusses current and historical aspects of ethical values in scientific research and technologies, as well as emerging perspectives of conducting ethical research in a variety of fields. Featuring research on topics such as clinical trials, human subjects, and informed consent, this book is ideally designed for practitioners, medical professionals, nurses, researchers, scientists, scholars, academicians, policy makers, and students seeking coverage on the ethical risks and limitations of research practice.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 150 pages
File Size : 42,5 Mb
Release : 2014-12-19
Category : Medical
ISBN : 9780309310031

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Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Author : Agency for Health Care Research and Quality (U.S.)
Publisher : Government Printing Office
Page : 204 pages
File Size : 49,7 Mb
Release : 2013-02-21
Category : Medical
ISBN : 9781587634239

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Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by Agency for Health Care Research and Quality (U.S.) Pdf

This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

Author : Canada. Comité consultatif national de l'immunisation,Canada. National Advisory Committee on Immunization
Publisher : Unknown
Page : 392 pages
File Size : 40,6 Mb
Release : 2006
Category : Immunization
ISBN : 0660193922

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Canadian Immunization Guide by Canada. Comité consultatif national de l'immunisation,Canada. National Advisory Committee on Immunization Pdf

The seventh edition of the Canadian Immunization Guide was developed by the National Advisory Committee on Immunization (NACI), with the support ofthe Immunization and Respiratory Infections Division, Public Health Agency of Canada, to provide updated information and recommendations on the use of vaccines in Canada. The Public Health Agency of Canada conducted a survey in 2004, which confi rmed that the Canadian Immunization Guide is a very useful and reliable resource of information on immunization.

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 163 pages
File Size : 46,5 Mb
Release : 2010-12-21
Category : Medical
ISBN : 9780309186513

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The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Author : Edmund A. C. Crouch,Richard Wilson
Publisher : Unknown
Page : 248 pages
File Size : 50,9 Mb
Release : 1982
Category : Business & Economics
ISBN : STANFORD:36105039207696

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Risk/benefit Analysis by Edmund A. C. Crouch,Richard Wilson Pdf

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.

Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher : Unknown
Page : 614 pages
File Size : 44,8 Mb
Release : 1978
Category : Human experimentation in medicine
ISBN : UCSD:31822000897728

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The Belmont Report by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Pdf

Author : UNESCO
Publisher : UNESCO
Page : 141 pages
File Size : 45,7 Mb
Release : 2011-12-30
Category : Bioethics
ISBN : 9789231042034

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Casebook on benefit and harm by UNESCO Pdf

Author : National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Improving Risk Analysis Approaches Used by the U.S. EPA
Publisher : National Academies Press
Page : 422 pages
File Size : 48,7 Mb
Release : 2009-03-24
Category : Political Science
ISBN : 9780309120463

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Science and Decisions by National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Improving Risk Analysis Approaches Used by the U.S. EPA Pdf

Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.