Principles and Practice of Clinical Trials

Principles and Practice of Clinical Trials PDF Author: Steven Piantadosi
Publisher: Springer Nature
ISBN: 3319526367
Category : Medical
Languages : en
Pages : 2573

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Book Description
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Principles and Practice of Clinical Trials

Principles and Practice of Clinical Trials PDF Author: Steven Piantadosi
Publisher: Springer Nature
ISBN: 3319526367
Category : Medical
Languages : en
Pages : 2573

Get Book Here

Book Description
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research PDF Author: John I. Gallin
Publisher: Elsevier
ISBN: 0080489567
Category : Science
Languages : en
Pages : 447

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Book Description
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government

Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine PDF Author: Richard Chin
Publisher: Elsevier
ISBN: 0080557937
Category : Medical
Languages : en
Pages : 560

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Book Description
Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. - Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data - Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine - Expert authorship whose experience includes running clinical trials in an academic as well as industry settings - Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy

Clinical Research

Clinical Research PDF Author: Manfred Stommel
Publisher: Lippincott Williams & Wilkins
ISBN: 9780781735186
Category : Medical
Languages : en
Pages : 484

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Book Description
This unique textbook integrates statistical concepts into evidence-based clinical practice and patient management. Research concepts and techniques are drawn from epidemiology, bio-statistics, and psychometrics, as well as educational and social science research. Clinical examples throughout the text illustrate practical and scientifically sound applications of the concepts. Data tables and research vignettes highlight statistical distributions involving probability. Methods to locate and utilize web-based information relevant to clinical research are discussed, and web URLs are provided. Further learning is encouraged by the inclusion of suggested activities, recommended readings, references, and a comprehensive glossary of research terms. Additional resources are available at a Connection Website, connection.LWW.com/go/stommel.

Principles of Good Clinical Practice

Principles of Good Clinical Practice PDF Author: Michael J. McGraw
Publisher: Pharmaceutical Press
ISBN: 0853697906
Category : Business & Economics
Languages : en
Pages : 273

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Book Description
Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.

Clinical Trials

Clinical Trials PDF Author: Stuart J. Pocock
Publisher: John Wiley & Sons
ISBN: 1118794109
Category : Medical
Languages : en
Pages : 228

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Book Description
This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.

Randomized Clinical Trials

Randomized Clinical Trials PDF Author: David Machin
Publisher: John Wiley & Sons
ISBN: 0470319224
Category : Medical
Languages : en
Pages : 375

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Book Description
Using examples and case studies from industry, academia and research literature, Randomized Clinical Trials provides a detailed overview of the key issues involved in designing, conducting, analysing and reporting randomized clinical trials. It examines the methodology for conducting Phase III clinical trials, developing the protocols, the practice for capturing, measuring, and analysing the resulting clinical data and their subsequent reporting. Randomized clinical trials are the principal method for determining the relative efficacy and safety of alternative treatments, interventions or medical devices. They are conducted by groups comprising one or more of pharmaceutical and allied health-care organisations, academic institutions, and charity supported research groups. In many cases such trials provide the key evidence necessary for the regulatory approval of a new product for future patient use. Randomized Clinical Trials provides comprehensive coverage of such trials, ranging from elementary to advanced level. Written by authors with considerable experience of clinical trials, Randomized Clinical Trials is an authoritative guide for clinicians, nurses, data managers and medical statisticians involved in clinical trials research and for health care professionals directly involved in patient care in a clinical trial context.

Principles and Practice of Clinical Electrophysiology of Vision, second edition

Principles and Practice of Clinical Electrophysiology of Vision, second edition PDF Author: John R. Heckenlively
Publisher: MIT Press
ISBN: 0262083469
Category : Medical
Languages : en
Pages : 1033

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Book Description
The long-awaited second edition of an authoritative reference on electrophysiologic vision testing, including detailed information on techniques and problems, basic physiology and anatomy, theoretical concepts, and clinical findings; with extensive new material. This authoritative text is the only comprehensive reference available on electrophysiologic vision testing, offering both practical information on techniques and problems as well as basic physiology and anatomy, theoretical concepts, and clinical correlations. The second edition, of the widely used text, offers extensive new material and updated information: 65 of the 84 chapters are completely new, with the changes reflecting recent advances in the field. The book will continue to be an essential resource for practitioners and scholars from a range of disciplines within vision science. The contributions not only cover new information—important material that is likely to become more important in the next decade—but also offer a long-range perspective on the field and its remarkable development in the last century. After discussing the history and background of clinical electrophysiology, the book introduces the anatomy of the retina and principles of cell biology in the visual pathways at the molecular, physiological, and biochemical levels. It relates these new findings to the techniques and interpretations of clinical tests, including the electro-oculogram (EOG), electroretinogram (ERG), and visual evoked potentials (VEP), which are discussed in detail, as are equipment, data acquisition and analysis, principles and protocols for clinical testing, diseases and dysfunction, and animal testing. Notable additions for this edition include chapters on the origin of electroretinogram waveforms, multifocal techniques, testing in standard laboratory animals, recent advances in analysis of abnormalities in disease, and the applications of these techniques to the study of genetic abnormalities.

Critical Thinking in Clinical Research

Critical Thinking in Clinical Research PDF Author: Felipe Fregni
Publisher: Oxford University Press
ISBN: 0199324492
Category : Medical
Languages : en
Pages : 537

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Book Description
Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.

ClinicalTrials

ClinicalTrials PDF Author: Curtis L. Meinert
Publisher: OUP USA
ISBN: 0195387880
Category : Medical
Languages : en
Pages : 702

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Book Description
The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.