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Publication And Disclosure Issues In Antidepressant Pediatric Clinical Trials
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Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations Publisher : ISBN 13 : Total Pages :724 pages Book Rating :4.X/5 (5 download)
Book Synopsis Publication and Disclosure Issues in Antidepressant Pediatric Clinical Trials by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Download or read book Publication and Disclosure Issues in Antidepressant Pediatric Clinical Trials written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 2004 with total page 724 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Pediatric Anxiety Disorders by : Scott N. Compton
Download or read book Pediatric Anxiety Disorders written by Scott N. Compton and published by Academic Press. This book was released on 2019-03-28 with total page 571 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pediatric Anxiety Disorders provides a critical, updated and comprehensive overview of anxiety disorders in children and adolescents based on the current state of empirical research. The book provides specific clinical recommendations which integrate new knowledge from neuroscience and innovative delivery formats for interventions. This is the first reference to examine anxiety diagnoses in accordance with the latest edition of the DSM-5, including childhood onset disorders, such as Separation Anxiety Disorder, Selective Mutism, Specific Phobia, Social Anxiety Disorder, Panic Disorder, Agoraphobia and Generalized Anxiety Disorder. The book assists clinicians in critically appraising the certainty of the evidence-base and the strength of clinical recommendations. - Uses the latest edition of the Diagnostic and Statistical Manual of Mental Disorders, the DSM-5 - Includes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach in assessing guideline development - Focuses on advances in etiology, assessment and treatment - Presents new advances in our understanding of the brain behind fear and anxiety - Uses a stepped care approach to treatment
Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Side Effects written by Alison Bass and published by Algonquin Books. This book was released on 2008-06-17 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the mental health reporter for the Boston Globe, Alison Bass's front-page reporting on conflicts of interest in medical research stunned readers, and her series on sexual misconduct among psychiatrists earned a Pulitzer Prize nomination. Now she turns her investigative skills to a controversial case that exposed the increased suicide rates among adolescents taking antidepressants such as Paxil, Prozac, and Zoloft. Side Effects tells the tale of a gutsy assistant attorney general who, along with an unlikely whistle-blower at an Ivy League university, uncovered evidence of deception behind one of the most successful drug campaigns in history. Paxil was the world's bestselling antidepressant in 2002. Pediatric prescriptions soared, even though there was no proof that the drug performed any better than sugar pills in treating children and adolescents, and the real risks the drugs posed were withheld from the public. The New York State Attorney General's office brought an unprecedented lawsuit against giant manufacturer GlaxoSmithKline, the maker of Paxil, for consumer fraud. The successful suit launched a tidal wave of protest that changed the way drugs are tested, sold, and marketed in this country. With meticulous research, Alison Bass shows us the underbelly of the pharmaceutical industry. She lays bare the unhealthy ties between the medical establishment, big pharma, and the FDA—relationships that place vulnerable children and adults at risk every day.
Book Synopsis Report on the Activity of the Committee on Energy and Commerce for the ... Congress by : United States. Congress. House. Committee on Energy and Commerce
Download or read book Report on the Activity of the Committee on Energy and Commerce for the ... Congress written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2005 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Side Effects written by Alison Bass and published by Algonquin Books. This book was released on 2008-01-01 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: An investigative journalist for the Boston Globe probes the controversy over increased suicide rates among teenagers taking common antidepressants, focusing on the efforts of a whistle-blower and the New York State Attorney General's office to bring an unprecedented lawsuit against the maker of Paxil that changed the way drugs are tested, sold, and marketed.
Download or read book CIS Annual written by and published by . This book was released on 2005 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Depression and Heart Disease by : Alexander Glassman
Download or read book Depression and Heart Disease written by Alexander Glassman and published by John Wiley & Sons. This book was released on 2011-06-20 with total page 110 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recently, there has been a growing awareness of the multiple interrelationships between depression and various physical diseases. Patients with psychiatric problems, particularly depression, may be more susceptible to cardiovascular disorders. Depression and Heart Disease synthesizes current evidence, including some previously unpublished data, in a concise, easy-to-read format. The authors succinctly describe the epidemiology, pathogenesis (including cytokines and genetics), and risk factors of the comorbidity between depression and heart disease. The book also reviews the best pharmacological and psychotherapeutic approaches for people with this comorbidity.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book Fluoxetine written by Graziano Pinna and published by . This book was released on 2015-04-01 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fluoxetine, best known by the trade name Prozac®, unlike other psychotropic drugs whose effects were serendipitously stumbled upon, was the first developed for a precise mechanism of action, that is, the ability to selectively inhibit serotonin reuptake, based upon the theory that increasing the availability of serotonin would treat major depression. Once approved by the FDA in 1987, fluoxetine quickly became the most prescribed psychotropic drug worldwide and its success in improving mood disorders has triggered the development of a large number of congener molecules, commonly known as SSRIs after their purported mechanism of action. However, a quarter of a century after its development, the idea that fluoxetine asserts its positive behavioral effect through inhibition of serotonergic reuptake is not firmly established. This book reviews several preclinical and clinical reports suggesting that the pharmacological effects of fluoxetine may be mediated by means other than the regulation of serotonin, including the regulation of gene expression, modifying epigenetic mechanisms as well as modifying microRNAs. One of the most prominent mechanisms for the therapeutic relevance of fluoxetine relates to influencing neuroplasticity by enhancing neurotropic factors, including BDNF signaling and altering adult neurogenesis. The ability of fluoxetine to rapidly increase neurosteroid levels accounts for the fast anxiolytic effects of this drug. Fluoxetine action at sigma-1 receptor or modulating glutamatergic neurotransmission as well as the combination of fluoxetine with other psychotropic drugs is discussed in relation to its therapeutic effects. While fluoxetine was primarily prescribed as an antidepressant, this drug currently represents a treatment of choice for a broad spectrum of psychiatric disorders, including post-traumatic stress disorder and a range of anxiety disorders. This drug even possesses analgesic actions and is a valuable therapy for stroke. This book also highlights emerging evidence on the gender-specific effects of fluoxetine, its potential adverse features, including its addiction liability in combination with psychostimulants, and the impact of perinatal fluoxetine exposure.
Book Synopsis Interpersonal Psychotherapy for Depressed Adolescents by : Laura Mufson
Download or read book Interpersonal Psychotherapy for Depressed Adolescents written by Laura Mufson and published by Guilford Press. This book was released on 2004-04-22 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: Grounded in extensive research and clinical experience, this manual provides a complete guide to interpersonal psychotherapy for depressed adolescents (IPT-A). IPT-A is an evidence-based brief intervention designed to meet the specific developmental needs of teenagers. Clinicians learn how to educate adolescents and their families about depression, work with associated relationship difficulties, and help clients manage their symptoms while developing more effective communication and interpersonal problem-solving skills. The book includes illustrative clinical vignettes, an extended case example, and information on the model's conceptual and empirical underpinnings. Helpful session checklists and sample assessment tools are featured in the appendices.
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :385 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. 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.
Download or read book Treatment of Depression written by and published by . This book was released on 1999 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Addressing the Barriers to Pediatric Drug Development by : Institute of Medicine
Download or read book Addressing the Barriers to Pediatric Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2008-08-12 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
Book Synopsis Issues in Discovery, Experimental, and Laboratory Medicine: 2012 Edition by :
Download or read book Issues in Discovery, Experimental, and Laboratory Medicine: 2012 Edition written by and published by ScholarlyEditions. This book was released on 2013-01-10 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: Issues in Discovery, Experimental, and Laboratory Medicine: 2012 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Medical Research. The editors have built Issues in Discovery, Experimental, and Laboratory Medicine: 2012 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Medical Research in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Discovery, Experimental, and Laboratory Medicine: 2012 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.
Download or read book Bad Pharma written by Ben Goldacre and published by Macmillan. This book was released on 2014-04 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.
Book Synopsis Ordinarily Well by : Peter D. Kramer
Download or read book Ordinarily Well written by Peter D. Kramer and published by Macmillan + ORM. This book was released on 2016-06-07 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: Do antidepressants work, or are they glorified dummy pills? How can we tell? In Ordinarily Well, the celebrated psychiatrist and author Peter D. Kramer examines the growing controversy about the popular medications. A practicing doctor who trained as a psychotherapist and worked with pioneers in psychopharmacology, Kramer combines moving accounts of his patients’ dilemmas with an eye-opening history of drug research to cast antidepressants in a new light. Kramer homes in on the moment of clinical decision making: Prescribe or not? What evidence should doctors bring to bear? Using the wide range of reference that readers have come to expect in his books, he traces and critiques the growth of skepticism toward antidepressants. He examines industry-sponsored research, highlighting its shortcomings. He unpacks the “inside baseball” of psychiatry—statistics—and shows how findings can be skewed toward desired conclusions. Kramer never loses sight of patients. He writes with empathy about his clinical encounters over decades as he weighed treatments, analyzed trial results, and observed medications’ influence on his patients’ symptoms, behavior, careers, families, and quality of life. He updates his prior writing about the nature of depression as a destructive illness and the effect of antidepressants on traits like low self-worth. Crucially, he shows how antidepressants act in practice: less often as miracle cures than as useful, and welcome, tools for helping troubled people achieve an underrated goal—becoming ordinarily well.
