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Clinical Trial Design Challenges in Mood Disorders

Author: Mauricio Tohen

Publisher: Academic Press

Published: 2015-01-24

Total Pages: 192

ISBN-13: 0124051766

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Poor clinical trial designs result in failed studies wasting research funds and limiting the advancement of cures for disorders. Clinical Trial Design Challenges in Mood Disorders outlines classic problems researchers face in designing clinical trials and discusses how best to address them for the most definitive and generalizable results. Traditional trial designs are included as well as novel analytic techniques. The book examines information on high placebo response, the generalizability of studies conducted in the developing world, the duration of maintenance studies, and the application of findings into clinical practice. With representation from contributors throughout the world and from academia, industry, regulatory agencies, and advocacy groups, this book will contribute toward improved clinical trial design and valid, precise, and reliable answers about what works better and faster for patients. Summarizes common trial design problems and their solutions Encompasses funding, subject selection, regulatory issues and more Identifies best practices for definitive and generalizable results Includes traditional trial designs and novel analytic techniques Represents academia, industry, regulatory agencies, and advocacy groups

Book Synopsis Clinical Trial Design Challenges in Mood Disorders by : Mauricio Tohen

Download or read book Clinical Trial Design Challenges in Mood Disorders written by Mauricio Tohen and published by Academic Press. This book was released on 2015-01-24 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Poor clinical trial designs result in failed studies wasting research funds and limiting the advancement of cures for disorders. Clinical Trial Design Challenges in Mood Disorders outlines classic problems researchers face in designing clinical trials and discusses how best to address them for the most definitive and generalizable results. Traditional trial designs are included as well as novel analytic techniques. The book examines information on high placebo response, the generalizability of studies conducted in the developing world, the duration of maintenance studies, and the application of findings into clinical practice. With representation from contributors throughout the world and from academia, industry, regulatory agencies, and advocacy groups, this book will contribute toward improved clinical trial design and valid, precise, and reliable answers about what works better and faster for patients. Summarizes common trial design problems and their solutions Encompasses funding, subject selection, regulatory issues and more Identifies best practices for definitive and generalizable results Includes traditional trial designs and novel analytic techniques Represents academia, industry, regulatory agencies, and advocacy groups

Neuroscience Trials of the Future

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2016-11-07

Total Pages: 111

ISBN-13: 0309442583

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On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

Book Synopsis Neuroscience Trials of the Future by : National Academies of Sciences, Engineering, and Medicine

Download or read book Neuroscience Trials of the Future written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-11-07 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2014-02-06

Total Pages: 107

ISBN-13: 0309292492

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Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Transforming Clinical Research in the United States

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2010-10-22

Total Pages: 151

ISBN-13: 0309163358

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An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

Book Synopsis Transforming Clinical Research in the United States by : Institute of Medicine

Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

Behavioral Clinical Trials for Chronic Diseases

Author: Lynda H. Powell

Publisher: Springer Nature

Published: 2021-10-13

Total Pages: 324

ISBN-13: 3030393305

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This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to “speak the language of medicine” through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine.

Book Synopsis Behavioral Clinical Trials for Chronic Diseases by : Lynda H. Powell

Download or read book Behavioral Clinical Trials for Chronic Diseases written by Lynda H. Powell and published by Springer Nature. This book was released on 2021-10-13 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to “speak the language of medicine” through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine.

The American Psychiatric Association Publishing Textbook of Mood Disorders, Second Edition

Author: Charles B. Nemeroff, M.D., Ph.D.

Publisher: American Psychiatric Pub

Published: 2022-06-16

Total Pages: 988

ISBN-13: 1615373314

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Preceded by: The American Psychiatric Publishing textbook of mood disorders / edited by Dan J. Stein, David J. Kupfer, Alan F. Schatzberg. 1st ed. c2006.

Book Synopsis The American Psychiatric Association Publishing Textbook of Mood Disorders, Second Edition by : Charles B. Nemeroff, M.D., Ph.D.

Download or read book The American Psychiatric Association Publishing Textbook of Mood Disorders, Second Edition written by Charles B. Nemeroff, M.D., Ph.D. and published by American Psychiatric Pub. This book was released on 2022-06-16 with total page 988 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preceded by: The American Psychiatric Publishing textbook of mood disorders / edited by Dan J. Stein, David J. Kupfer, Alan F. Schatzberg. 1st ed. c2006.

The Medical Basis of Psychiatry

Author: S. Hossein Fatemi

Publisher: Springer

Published: 2016-03-17

Total Pages: 1064

ISBN-13: 1493925288

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Four years have passed since the last edition (3rd) of this book was published. In the intervening years, several reviews of this book have provided highly encouraging remarks about the value of this book in transmitting information on classification and treatment of psychiatric disorders to the audience. We are proposing to revise all chapters with an eye on accuracy and ease of use, and this is an especially timely endeavor with the upcoming publication of the Diagnostic and Statistical Manual V. All the appropriate new information on biology, etiology, diagnosis and treatment of psychiatric disorders will be added to the current proposed edition. It is our goal to recruit the same authors (if possible) who contributed to the previous edition. While all chapters will be updated (see TOC), those marked by asterisks will be the most likely to undergo more revision. Psychiatry has emerged as a burgeoning scientific field with major advances in etiology and treatment of several disorders. Just as there was excitement in the anatomic advances that took place a hundred years ago when Emil Kraepelin and his collaborators took on the enormous task of classification of psychiatric disorders based on rational scientific thinking, new advances in genetics, biochemistry, neuroanatomy and pharmacotherapy of mental disorders have brought us even closer to a better understanding of complex disorders like schizophrenia, bipolar disorder, depression and even autism. The major goal of the previous edition of this classic book was to update the busy clinician, psychiatric resident and medical student with the most up-to-date information on etiology, diagnosis and treatment of psychiatric disorders. This goal remains the focus of the fourth edition of this book. In this updated and expanded edition, the reader will be provided with the most contemporary information and literature supported by a close survey of the field. This new edition of this classic title, with its focus on biologic and medical aspects of psychiatry, will continue to be of significant help to all interested in the scientific practice of psychiatry.

Book Synopsis The Medical Basis of Psychiatry by : S. Hossein Fatemi

Download or read book The Medical Basis of Psychiatry written by S. Hossein Fatemi and published by Springer. This book was released on 2016-03-17 with total page 1064 pages. Available in PDF, EPUB and Kindle. Book excerpt: Four years have passed since the last edition (3rd) of this book was published. In the intervening years, several reviews of this book have provided highly encouraging remarks about the value of this book in transmitting information on classification and treatment of psychiatric disorders to the audience. We are proposing to revise all chapters with an eye on accuracy and ease of use, and this is an especially timely endeavor with the upcoming publication of the Diagnostic and Statistical Manual V. All the appropriate new information on biology, etiology, diagnosis and treatment of psychiatric disorders will be added to the current proposed edition. It is our goal to recruit the same authors (if possible) who contributed to the previous edition. While all chapters will be updated (see TOC), those marked by asterisks will be the most likely to undergo more revision. Psychiatry has emerged as a burgeoning scientific field with major advances in etiology and treatment of several disorders. Just as there was excitement in the anatomic advances that took place a hundred years ago when Emil Kraepelin and his collaborators took on the enormous task of classification of psychiatric disorders based on rational scientific thinking, new advances in genetics, biochemistry, neuroanatomy and pharmacotherapy of mental disorders have brought us even closer to a better understanding of complex disorders like schizophrenia, bipolar disorder, depression and even autism. The major goal of the previous edition of this classic book was to update the busy clinician, psychiatric resident and medical student with the most up-to-date information on etiology, diagnosis and treatment of psychiatric disorders. This goal remains the focus of the fourth edition of this book. In this updated and expanded edition, the reader will be provided with the most contemporary information and literature supported by a close survey of the field. This new edition of this classic title, with its focus on biologic and medical aspects of psychiatry, will continue to be of significant help to all interested in the scientific practice of psychiatry.

Understanding Research for Nursing Students

Author: Peter Ellis

Publisher: Learning Matters

Published: 2018-10-29

Total Pages: 209

ISBN-13: 1526459698

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This bestselling introduction to research supports those new to the topic by demystifying jargon and simply explaining the key concepts.

Book Synopsis Understanding Research for Nursing Students by : Peter Ellis

Download or read book Understanding Research for Nursing Students written by Peter Ellis and published by Learning Matters. This book was released on 2018-10-29 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: This bestselling introduction to research supports those new to the topic by demystifying jargon and simply explaining the key concepts.

The Ethical Challenges of Emerging Medical Technologies

Author: Arthur L. Caplan

Publisher: Routledge

Published: 2020-09-10

Total Pages: 672

ISBN-13: 1000151999

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This collection of essays emphasizes society’s increasingly responsible engagement with ethical challenges in emerging medical technology. Expansion of technological capacity and attention to patient safety have long been integral to improving healthcare delivery but only relatively recently have concepts like respect, distributive justice, privacy, and autonomy gained some power to shape the development, use, and refinement of medical tools and techniques. Medical ethics goes beyond making better medicine to thinking about how to make the field of medicine better. These essays showcase several ways in which modern ethical thinking is improving safety, efficacy and efficiency of medical technology, increasing access to medical care, and empowering patients to choose care that comports with their desires and beliefs. Included are complimentary ethical approaches as well as compelling counter-arguments. Together, the articles demonstrate how improving the quality of medical technology relies on every stakeholder -- not just medical researchers and scientists -- to assess each given technology’s strengths and pitfalls. This collection also portends one of the next major issues in the ethics of medical technology: developing the requisite moral framework to accompany shifts toward patient-centred personalized healthcare.

Book Synopsis The Ethical Challenges of Emerging Medical Technologies by : Arthur L. Caplan

Download or read book The Ethical Challenges of Emerging Medical Technologies written by Arthur L. Caplan and published by Routledge. This book was released on 2020-09-10 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection of essays emphasizes society’s increasingly responsible engagement with ethical challenges in emerging medical technology. Expansion of technological capacity and attention to patient safety have long been integral to improving healthcare delivery but only relatively recently have concepts like respect, distributive justice, privacy, and autonomy gained some power to shape the development, use, and refinement of medical tools and techniques. Medical ethics goes beyond making better medicine to thinking about how to make the field of medicine better. These essays showcase several ways in which modern ethical thinking is improving safety, efficacy and efficiency of medical technology, increasing access to medical care, and empowering patients to choose care that comports with their desires and beliefs. Included are complimentary ethical approaches as well as compelling counter-arguments. Together, the articles demonstrate how improving the quality of medical technology relies on every stakeholder -- not just medical researchers and scientists -- to assess each given technology’s strengths and pitfalls. This collection also portends one of the next major issues in the ethics of medical technology: developing the requisite moral framework to accompany shifts toward patient-centred personalized healthcare.

Healthy Aging

Author: Patrick P. Coll

Publisher: Springer

Published: 2019-03-29

Total Pages: 399

ISBN-13: 3030062007

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This book weaves all of these factors together to engage in and promote medical, biomedical and psychosocial interventions, including lifestyle changes, for healthier aging outcomes. The text begins with an introduction to age-related changes that increase in disease and disability commonly associated with old age. Written by experts in healthy aging, the text approaches the principles of disease and disability prevention via specific health issues. Each chapter highlights the challenge of not just increasing life expectancy but also deceasing disease burden and disability in old age. The text then shifts into the whole-person implications for clinicians working with older patients, including the social and cultural considerations that are necessary for improved outcomes as Baby Boomers age and healthcare systems worldwide adjust. Healthy Aging is an important resource for those working with older patients, including geriatricians, family medicine physicians, nurses, gerontologists, students, public health administrators, and all other medical professionals.

Book Synopsis Healthy Aging by : Patrick P. Coll

Download or read book Healthy Aging written by Patrick P. Coll and published by Springer. This book was released on 2019-03-29 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book weaves all of these factors together to engage in and promote medical, biomedical and psychosocial interventions, including lifestyle changes, for healthier aging outcomes. The text begins with an introduction to age-related changes that increase in disease and disability commonly associated with old age. Written by experts in healthy aging, the text approaches the principles of disease and disability prevention via specific health issues. Each chapter highlights the challenge of not just increasing life expectancy but also deceasing disease burden and disability in old age. The text then shifts into the whole-person implications for clinicians working with older patients, including the social and cultural considerations that are necessary for improved outcomes as Baby Boomers age and healthcare systems worldwide adjust. Healthy Aging is an important resource for those working with older patients, including geriatricians, family medicine physicians, nurses, gerontologists, students, public health administrators, and all other medical professionals.