Clinical Trial Design Challenges in Mood Disorders Book

Clinical Trial Design Challenges in Mood Disorders


  • Author : Mauricio Tohen
  • Publisher : Academic Press
  • Release Date : 2015-01-22
  • Genre: Medical
  • Pages : 192
  • ISBN 10 : 0124051707

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Clinical Trial Design Challenges in Mood Disorders Excerpt :

Poor clinical trial designs result in failed studies wasting hundreds of thousands of dollars in research funds. Poor clinical trial designs limit the rapid advancement of cures for disorders. Yet it's relatively easy to avoid classic poor designs via education about what constitutes good design and what the potential outcomes are for any shortcuts taken. The proposed book outlines the classic problems that researchers are faced with in designing clinical trials, whether its money, selection of subjects, regulatory issues etc, and how best to address them for the most definitive and generalizable results. This book is specific to clinical trial issues in psychiatric research, and comes from a task force in Bipolar Research. The contents herein were identified as the most major issues in psychiatric research. Authored by international contributors from academia, industry, regulatory agencies, and advocacy groups, this book summarizes problems in clinical design and the results of same, and whether and how the results can be applied into clinical practice. Edited by highly respected experts in psychiatric clinical trials Encompasses issues in the academic, industry, and regulatory worlds Includes clinical design and analysis Encompasses translation of research findings into practice

Clinical Trial Design Challenges in Mood Disorders Book

Clinical Trial Design Challenges in Mood Disorders


  • Author : Mauricio Tohen
  • Publisher : Academic Press
  • Release Date : 2015-01-24
  • Genre: Medical
  • Pages : 192
  • ISBN 10 : 9780124051768

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Clinical Trial Design Challenges in Mood Disorders 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 Book

Neuroscience Trials of the Future


  • Author : National Academies of Sciences, Engineering, and Medicine
  • Publisher : National Academies Press
  • Release Date : 2016-12-07
  • Genre: Medical
  • Pages : 111
  • ISBN 10 : 9780309442558

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Neuroscience Trials of the Future 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.

Clinical Trials in Older Adults Book

Clinical Trials in Older Adults


  • Author : Antonio Cherubini
  • Publisher : John Wiley & Sons
  • Release Date : 2016-01-13
  • Genre: Medical
  • Pages : 280
  • ISBN 10 : 9781118323472

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Clinical Trials in Older Adults Excerpt :

Clinical Trials in Older Adults is the first book to consider the methodological issues underlying the evaluation of new treatments in older people. Provides information on the methodology, monitoring and regulations for those planning to conduct a clinical trials involving older adults Contains examples of ongoing trials involving older adults, and presents the main characteristics of many recently published Depicts how the issues regarding older adults in clinical trials could be properly addressed with the appropriate study design and conduct Identifies key issues in performing clinical trials in older patients with common geriatric conditions, i.e. Alzheimer’s dementia, depression, low muscle mass, cancer

Small Clinical Trials Book

Small Clinical Trials


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2001-01-01
  • Genre: Medical
  • Pages : 222
  • ISBN 10 : 0309171148

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Small Clinical Trials Excerpt :

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

The Bipolar Book Book

The Bipolar Book


  • Author : Aysegül Yildiz
  • Publisher : Oxford University Press, USA
  • Release Date : 2015
  • Genre: Manic-depressive illness
  • Pages : 710
  • ISBN 10 : 9780199300532

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The Bipolar Book Excerpt :

The Bipolar Book covers not only clinical and pathophysiological matters, but also technical aspects of the evidence accumulation for treatment of bipolar disorder.

Behavioral Clinical Trials for Chronic Diseases Book

Behavioral Clinical Trials for Chronic Diseases


  • Author : Lynda H. Powell
  • Publisher : Springer Nature
  • Release Date : 2021
  • Genre: Alternative medicine
  • Pages : 324
  • ISBN 10 : 9783030393304

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Behavioral Clinical Trials for Chronic Diseases 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 Book

The American Psychiatric Association Publishing Textbook of Mood Disorders Second Edition


  • Author : Charles B. Nemeroff, M.D., Ph.D.
  • Publisher : American Psychiatric Pub
  • Release Date : 2022-06-16
  • Genre: Medical
  • Pages : 988
  • ISBN 10 : 9781615373314

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The American Psychiatric Association Publishing Textbook of Mood Disorders Second Edition 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 Ethical Challenges of Emerging Medical Technologies Book

The Ethical Challenges of Emerging Medical Technologies


  • Author : Arthur L. Caplan
  • Publisher : Routledge
  • Release Date : 2020-09-10
  • Genre: Medical
  • Pages : 482
  • ISBN 10 : 9781000151992

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The Ethical Challenges of Emerging Medical Technologies 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.

The Medical Basis of Psychiatry Book

The Medical Basis of Psychiatry


  • Author : S. Hossein Fatemi
  • Publisher : Springer
  • Release Date : 2016-03-17
  • Genre: Medical
  • Pages : 1064
  • ISBN 10 : 9781493925285

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The Medical Basis of Psychiatry 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 biolo

Understanding Research for Nursing Students Book

Understanding Research for Nursing Students


  • Author : Peter Ellis
  • Publisher : Learning Matters
  • Release Date : 2022-04-08
  • Genre: Medical
  • Pages : 200
  • ISBN 10 : 9781529786668

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Understanding Research for Nursing Students Excerpt :

Get to grips with all aspects of research that you need to succeed in your nursing degree. Learn why research is so important to nursing, develop your knowledge of key methods and terminology and build your confidence in applying research principles to your nursing practice. Key features o Each chapter is mapped to the 2018 NMC standards, showing how research relates to the requirements of a registered nurse o Straightforward language and a step-by-step approach introduce you to key concepts and guide you through all aspects of the research process o Filled with activities and case studies to help you apply research principles and methods to your studies and practice

Improving and Accelerating Therapeutic Development for Nervous System Disorders Book

Improving and Accelerating Therapeutic Development for Nervous System Disorders


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2014-02-06
  • Genre: Medical
  • Pages : 118
  • ISBN 10 : 9780309292498

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Improving and Accelerating Therapeutic Development for Nervous System Disorders 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.

Healthy Aging Book

Healthy Aging


  • Author : Patrick P. Coll
  • Publisher : Springer
  • Release Date : 2019-03-29
  • Genre: Medical
  • Pages : 399
  • ISBN 10 : 9783030062002

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Healthy Aging 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.

Posttraumatic Stress and Substance Use Disorders Book

Posttraumatic Stress and Substance Use Disorders


  • Author : Anka A. Vujanovic
  • Publisher : Routledge
  • Release Date : 2019-04-23
  • Genre: Psychology
  • Pages : 376
  • ISBN 10 : 9781315442624

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Posttraumatic Stress and Substance Use Disorders Excerpt :

Posttraumatic Stress and Substance Use Disorders summarizes the state of the field from a biopsychosocial perspective, addressing key domains of interest to clinicians, students, instructors, and researchers. This book is a valuable resource and reference guide for multidisciplinary practitioners and scientists interested in the evidence-based assessment and treatment of posttraumatic stress and substance use disorders. Chapters written by leaders in the field cover the latest research on assessment, diagnosis, evidence-based treatments, future directions, and much more.

Pocket Psychiatry Book

Pocket Psychiatry


  • Author : John B. Taylor
  • Publisher : Lippincott Williams & Wilkins
  • Release Date : 2019-03-21
  • Genre: Medical
  • Pages : 350
  • ISBN 10 : 9781975117948

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Pocket Psychiatry Excerpt :

Pocket Psychiatry, a new addition to the Pocket Notebook series, is written by residents for residents. A resource for essential information, in a high-yield, easy-to-use format, designed to help students, trainees, and others navigate the initial psychiatric evaluation and management of the most commonly encountered psychiatric conditions. With an emphasis on evidence-based information, Pocket Psychiatry, provides a rare concise and accessible resource, for must-know information on hospital- and clinic-based psychiatric care — from history and physical exam to differential diagnosis testing to therapeutics — in the well known loose leaf pocket size format.