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Author: Salah M. Abdel-aleem
Publisher: John Wiley & Sons
ISBN: 9780470475904
Category : Medical
Languages : en
Pages : 296
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Book Description
An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.
Author: Salah M. Abdel-aleem
Publisher: John Wiley & Sons
ISBN: 9780470475904
Category : Medical
Languages : en
Pages : 296
Get Book Here
Book Description
An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.
Author: Salah M. Abdel-aleem
Publisher: John Wiley & Sons
ISBN: 1118164628
Category : Medical
Languages : en
Pages : 269
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Book Description
Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.
Author: Karen M. Becker
Publisher: Springer Science & Business Media
ISBN: 1597450049
Category : Technology & Engineering
Languages : en
Pages : 342
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Book Description
The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.
Author: JoAnn Pfeiffer
Publisher: CRC Press
ISBN: 1315299771
Category : Mathematics
Languages : en
Pages : 292
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Book Description
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Author: Ciprian Dobre
Publisher: Morgan Kaufmann
ISBN: 0128037024
Category : Computers
Languages : en
Pages : 550
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Book Description
Pervasive Computing: Next Generation Platforms for Intelligent Data Collection presents current advances and state-of-the-art work on methods, techniques, and algorithms designed to support pervasive collection of data under ubiquitous networks of devices able to intelligently collaborate towards common goals. Using numerous illustrative examples and following both theoretical and practical results the authors discuss: a coherent and realistic image of today's architectures, techniques, protocols, components, orchestration, choreography, and developments related to pervasive computing components for intelligently collecting data, resource, and data management issues; the importance of data security and privacy in the era of big data; the benefits of pervasive computing and the development process for scientific and commercial applications and platforms to support them in this field. Pervasive computing has developed technology that allows sensing, computing, and wireless communication to be embedded in everyday objects, from cell phones to running shoes, enabling a range of context-aware applications. Pervasive computing is supported by technology able to acquire and make use of the ubiquitous data sensed or produced by many sensors blended into our environment, designed to make available a wide range of new context-aware applications and systems. While such applications and systems are useful, the time has come to develop the next generation of pervasive computing systems. Future systems will be data oriented and need to support quality data, in terms of accuracy, latency and availability. Pervasive Computing is intended as a platform for the dissemination of research efforts and presentation of advances in the pervasive computing area, and constitutes a flagship driver towards presenting and supporting advanced research in this area. Indexing: The books of this series are submitted to EI-Compendex and SCOPUS - Offers a coherent and realistic image of today's architectures, techniques, protocols, components, orchestration, choreography, and development related to pervasive computing - Explains the state-of-the-art technological solutions necessary for the development of next-generation pervasive data systems, including: components for intelligently collecting data, resource and data management issues, fault tolerance, data security, monitoring and controlling big data, and applications for pervasive context-aware processing - Presents the benefits of pervasive computing, and the development process of scientific and commercial applications and platforms to support them in this field - Provides numerous illustrative examples and follows both theoretical and practical results to serve as a platform for the dissemination of research advances in the pervasive computing area
Author: Bernard Ravina
Publisher: Cambridge University Press
ISBN: 1107376572
Category : Medical
Languages : en
Pages : 387
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Book Description
Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.
Author: Klasien Horstman
Publisher: Lulu.com
ISBN: 1446687147
Category :
Languages : en
Pages : 328
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Book Description
Author:
Publisher: Academic Press
ISBN: 0123786118
Category : Science
Languages : en
Pages : 2626
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Book Description
In a world of 24-hour media saturation, sleep has become an increasingly fraught enterprise. The award-winning four-volume Encyclopedia of Sleep, Four Volume Set is the largest reference, either online or in print, on the subject of sleep. Written to be useful for the novice and the established researcher and clinician, Topic areas will include sleep across the life cycle and in other species, sleep and women, sleep and the elderly, pediatric sleep, sleep deprivation and loss, sleep mechanisms, sleep physiology and pathophysiology, sleep disorders, neurobiology, chronobiology, pharmacology, and impact of other disorders on sleep. Recognizing the many fields that are connected to sleep science, the editorial team has been carefully chosen to do justice to this highly interdisciplinary field of study. The steady growth of researchers and clinicians in the sleep field attests to the continued interest in the scientific study of sleep and the management of patients with sleep disorders, and anyone involved in this exciting field should find this work to be an invaluable reference. 2013 PROSE Award winner for Multivolume Reference in Science from the Association of American Publishers Thoroughly interdisciplinary: looks at sleep throughout the life cycle, with exceptional coverage of basic sleep concepts, the physiology of sleep as well as sleep disorders of all descriptions Excellent coverage of sleep and special populations, covering the lifespan, as well as gender and ethnic differences, among others Chapters focusing on sleep disorders are grouped under the broad categories classified in the ICSD-2 for clear organization so that the reader can effectively access the steps involved in diagnosing and treating these disorders Online version is linked both within the encyclopedia (to related content) and to external sources (such as primary journal content) so that users have easy access to more detailed information if needed
Author: Luigi Ambrosio
Publisher: Elsevier
ISBN: 0857096192
Category : Medical
Languages : en
Pages : 645
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Book Description
There have been important developments in materials and therapies for the treatment of spinal conditions. Biomaterials for spinal surgery summarises this research and how it is being applied for the benefit of patients.After an introduction to the subject, part one reviews fundamental issues such as spinal conditions and their pathologies, spinal loads, modelling and osteobiologic agents in spinal surgery. Part two discusses the use of bone substitutes and artificial intervertebral discs whilst part three covers topics such as the use of injectable biomaterials like calcium phosphate for vertebroplasty and kyphoplasty as well as scoliosis implants. The final part of the book summarises developments in regenerative therapies such as the use of stem cells for intervertebral disc regeneration.With its distinguished editors and international team of contributors, Biomaterials for spinal surgery is a standard reference for both those developing new biomaterials and therapies for spinal surgery and those using them in clinical practice. - Summarises recent developments in materials and therapies for the treatment of spinal conditions and examines how it is being applied for the benefit of patients - Reviews fundamental issues such as spinal conditions and their pathologies, spinal loads, modelling and osteobiologic agents in spinal surgery - Discusses the use of bone substitutes and artificial intervertebral discs and covers topics such as the use of injectable biomaterials like calcium phosphate for vertebroplasty and kyphoplasty
Author: Yuan Zhi Wang
Publisher: Trans Tech Publications Ltd
ISBN: 3038135240
Category : Technology & Engineering
Languages : en
Pages : 624
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Book Description
Selected, peer reviewed papers from the 2010 International Symposium on Quantum, Nano and Micro Technologies (ISQNM 2010), October 27-28, 2010,Chengdu, China
