Ethical And Scientific Issues In Studying The Safety Of Approved Drugs PDF Download
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Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 292 |
Release | : 2012-07-30 |
Genre | : Medical |
ISBN | : 0309218160 |
Download Ethical and Scientific Issues in Studying the Safety of Approved Drugs Book in PDF, ePub and Kindle
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 | : Institute of Medicine (U.S.). Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs |
Publisher | : |
Total Pages | : 15 |
Release | : 2010 |
Genre | : Clinical trials |
ISBN | : 9780309157780 |
Download Ethical Issues in Studying the Safety of Approved Drugs Book in PDF, ePub and Kindle
The FDA requested that the IOM examine the ethical and informed consent issues that should be considered when conducting clinical trials to evaluate drug safety. This report outlines when and how the FDA should conduct clinical trials to protect the public's health and the health of trial participants.
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 432 |
Release | : 2012-10-13 |
Genre | : Medical |
ISBN | : 0309225493 |
Download Safe and Effective Medicines for Children Book in PDF, ePub and Kindle
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 445 |
Release | : 2004-07-09 |
Genre | : Medical |
ISBN | : 0309133386 |
Download Ethical Conduct of Clinical Research Involving Children Book in PDF, ePub and Kindle
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 | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 346 |
Release | : 2007-02-27 |
Genre | : Medical |
ISBN | : 0309133947 |
Download The Future of Drug Safety Book in PDF, ePub and Kindle
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Author | : Cortney Weinbaum |
Publisher | : |
Total Pages | : 118 |
Release | : 2019-06-05 |
Genre | : Law |
ISBN | : 9781977402691 |
Download Ethics in Scientific Research Book in PDF, ePub and Kindle
Scientific research ethics vary by discipline and by country, and this analysis sought to understand those variations. The authors reviewed literature and conducted interviews to provide researchers, government officials, and others who create, modify, and enforce ethics in scientific research around the world with an understanding of how ethics are created, monitored, and enforced across scientific disciplines and across international borders.
Author | : National Research Council |
Publisher | : National Academies Press |
Total Pages | : 226 |
Release | : 2004-06-04 |
Genre | : Science |
ISBN | : 0309166411 |
Download Intentional Human Dosing Studies for EPA Regulatory Purposes Book in PDF, ePub and Kindle
The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.
Author | : Anna C. Mastroianni |
Publisher | : |
Total Pages | : 268 |
Release | : 1994 |
Genre | : Human experimentation in medicine |
ISBN | : |
Download Women and Health Research Book in PDF, ePub and Kindle
Author | : Peter G. Smith |
Publisher | : |
Total Pages | : 479 |
Release | : 2015 |
Genre | : Health & Fitness |
ISBN | : 0198732864 |
Download Field Trials of Health Interventions Book in PDF, ePub and Kindle
This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.
Author | : Council for International Organizations of Medical Sciences (CIOMS) |
Publisher | : World Health Organization |
Total Pages | : 0 |
Release | : 2017-01-31 |
Genre | : Bioethics |
ISBN | : 9789290360889 |
Download International Ethical Guidelines for Health-Related Research Involving Humans Book in PDF, ePub and Kindle
"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.