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 | : 2012-08-30 |
| Genre | : Medical |
| ISBN | : 0309218136 |
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 | : 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 | : 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 | : 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 | : 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.
| Author | : Peter G. Smith |
| Publisher | : Oxford University Press, USA |
| Total Pages | : 479 |
| Release | : 2015 |
| Genre | : Medical |
| ISBN | : 0198732864 |
Download Field Trials of Health Interventions Book in PDF, ePub and Kindle
"IEA, International Epidemiological Association, Welcome Trust."
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 312 |
| Release | : 2003-01-06 |
| Genre | : Medical |
| ISBN | : 0309169038 |
Download Responsible Research Book in PDF, ePub and Kindle
When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€"but also including volunteers who may agree to serve as research participants.
| Author | : Ezekiel J. Emanuel |
| Publisher | : OUP USA |
| Total Pages | : 848 |
| Release | : 2011-02 |
| Genre | : Medical |
| ISBN | : 0199768633 |
Download The Oxford Textbook of Clinical Research Ethics Book in PDF, ePub and Kindle
The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
