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Principles And Practice Of Clinical Research

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Principles and Practice of Clinical Research

Principles and Practice of Clinical Research Book
Author : John I. Gallin,Frederick P Ognibene
Publisher : Elsevier
Release : 2011-04-28
ISBN : 9780080489568
Language : En, Es, Fr & De

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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 Book
Author : Richard Chin,Bruce Y Lee
Publisher : Elsevier
Release : 2008-07-25
ISBN : 9780080557939
Language : En, Es, Fr & De

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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

Principles and Practice of Clinical Trials

Principles and Practice of Clinical Trials Book
Author : Steven Piantadosi,Curtis L. Meinert
Publisher : Springer
Release : 2022-09-21
ISBN : 9783319526355
Language : En, Es, Fr & De

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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.

Critical Thinking in Clinical Research

Critical Thinking in Clinical Research Book
Author : Felipe Fregni,Ben M. W. Illigens
Publisher : Oxford University Press
Release : 2018
ISBN : 0199324492
Language : En, Es, Fr & De

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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.

Clinical Research

Clinical Research Book
Author : Manfred Stommel,Celia Wills
Publisher : Lippincott Williams & Wilkins
Release : 2004
ISBN : 9780781735186
Language : En, Es, Fr & De

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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 Book
Author : Michael J. McGraw,Shawn P. Shearn
Publisher : Pharmaceutical Press
Release : 2010
ISBN : 0853697906
Language : En, Es, Fr & De

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Book Description :

This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials, as well as providing a historical perspective of the clinical research landscape. Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights. Principles of Good Clinical Practice describes the ethical principles and regulatory requirements that influence the current and future conduct of clinical research. As well as providing essential information on clinical trial design and pharmacovigilance, coverage also includes: informed consent; investigator and sponsor responsibilities; site monitoring; institutional review boards and dependent ethics committees; clinical trial registration and reporting; quality assurance; and future implications for good clinical practices. Principles of Good Clinical Practice will be a definitive text for Clinical Development personnel at pharmaceutical companies, Contract Research Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries

Clinical Research in Oral Health

Clinical Research in Oral Health Book
Author : William V. Giannobile,Brian A. Burt,Robert J. Genco
Publisher : John Wiley & Sons
Release : 2009-12-09
ISBN : 9780813820552
Language : En, Es, Fr & De

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Book Description :

Clinical Research in Oral Health surveys the essentials of clinical research in oral health, anchoring these principles within the specific context of the oral health arena. Addressing research questions exclusively applicable to dentistry and oral health, the book thoroughly illustrates the principles and practice of oral health clinical research. Clinical Research in Oral Health also clarifies the framework of regulatory issues and presents emerging concepts in clinical translation, relating the research principles to clinical improvement.

Clinical Trials

Clinical Trials Book
Author : Stuart J. Pocock
Publisher : John Wiley & Sons
Release : 2013-07-17
ISBN : 1118794109
Language : En, Es, Fr & De

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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.

Clinical Trials in Cancer

Clinical Trials in Cancer Book
Author : David J. Girling
Publisher : Oxford University Press, USA
Release : 2003
ISBN : 9780192629593
Language : En, Es, Fr & De

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Book Description :

Clinical Trials in Cancer provides concise, accessible and practical information on the practicalities of planning, designing, conducting, analysing, reporting, and interpreting phase III clinical trials predominantly, but also single-arm and randomized phase II trials. The book shows clearly how recent developments and current thinking can be implemented. Information on the need to decide and measure realistic target differences in trials, the conduct and interpretation of interim analyses, patient advocacy, good clinical practice, the study of quality of life, the role of meta-analyses, and informed consent and other ethical issues are also covered. DEGREESNL This book will prove invaluable for medical, statistical, and biological cancer researchers, health care professionals, and researchers in the pharmaceutical industry. Trial sponsors, principal investigators, members of data monitoring and trial supervisory committees, specialists invited to provide independent assessments, and many others involved in all aspects of research related to clinical trials should also find this book helpful.

Principles of Research Methodology

Principles of Research Methodology Book
Author : Phyllis G. Supino,Jeffrey S. Borer
Publisher : Springer Science & Business Media
Release : 2012-06-22
ISBN : 1461433606
Language : En, Es, Fr & De

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Book Description :

Principles of Research Methodology: A Guide for Clinical Investigators is the definitive, comprehensive guide to understanding and performing clinical research. Designed for medical students, physicians, basic scientists involved in translational research, and other health professionals, this indispensable reference also addresses the unique challenges and demands of clinical research and offers clear guidance in becoming a more successful member of a medical research team and critical reader of the medical research literature. The book covers the entire research process, beginning with the conception of the research problem to publication of findings. Principles of Research Methodology: A Guide for Clinical Investigators comprehensively and concisely presents concepts in a manner that is relevant and engaging to read. The text combines theory and practical application to familiarize the reader with the logic of research design and hypothesis construction, the importance of research planning, the ethical basis of human subjects research, the basics of writing a clinical research protocol and scientific paper, the logic and techniques of data generation and management, and the fundamentals and implications of various sampling techniques and alternative statistical methodologies. Organized in thirteen easy to read chapters, the text emphasizes the importance of clearly-defined research questions and well-constructed hypothesis (reinforced throughout the various chapters) for informing methods and in guiding data interpretation. Written by prominent medical scientists and methodologists who have extensive personal experience in biomedical investigation and in teaching key aspects of research methodology to medical students, physicians and other health professionals, the authors expertly integrate theory with examples and employ language that is clear and useful for a general medical audience. A major contribution to the methodology literature, Principles of Research Methodology: A Guide for Clinical Investigators is an authoritative resource for all individuals who perform research, plan to perform it, or wish to understand it better.

Neuroepidemiology

Neuroepidemiology Book
Author : Lorene M. Nelson
Publisher : Oxford University Press
Release : 2004
ISBN : 019513379X
Language : En, Es, Fr & De

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Book Description :

This fine text provides a comprehensive overview of methods for epidemiologic and clinical research on neurological disorders. The book focuses on classic principles of study design in epidemiologic research, strategies for avoiding study biases, methods for conducting clinical trials and prognostic studies, and principles of evidence-based medicine in neurology. The text gives neurologists, epidemiologists, and their students the foundation for conducting rigorous epidemiologic and clinical research on neurologic disorders.

Principles and Practice of Case based Clinical Reasoning Education

Principles and Practice of Case based Clinical Reasoning Education Book
Author : Olle ten Cate,Eugène J.F.M. Custers,Steven J. Durning
Publisher : Springer
Release : 2017-11-06
ISBN : 3319648284
Language : En, Es, Fr & De

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Book Description :

This book is open access under a CC BY 4.0 license. This volume describes and explains the educational method of Case-Based Clinical Reasoning (CBCR) used successfully in medical schools to prepare students to think like doctors before they enter the clinical arena and become engaged in patient care. Although this approach poses the paradoxical problem of a lack of clinical experience that is so essential for building proficiency in clinical reasoning, CBCR is built on the premise that solving clinical problems involves the ability to reason about disease processes. This requires knowledge of anatomy and the working and pathology of organ systems, as well as the ability to regard patient problems as patterns and compare them with instances of illness scripts of patients the clinician has seen in the past and stored in memory. CBCR stimulates the development of early, rudimentary illness scripts through elaboration and systematic discussion of the courses of action from the initial presentation of the patient to the final steps of clinical management. The book combines general backgrounds of clinical reasoning education and assessment with a detailed elaboration of the CBCR method for application in any medical curriculum, either as a mandatory or as an elective course. It consists of three parts: a general introduction to clinical reasoning education, application of the CBCR method, and cases that can used by educators to try out this method.

Clinical Epidemiology

Clinical Epidemiology Book
Author : Diederick E. Grobbee,Professor of Clinical Epidemiology Julius Center for Health Sciences and Primary Care University Medical Center Utrecht Utrecht Netherlands Diederick E Grobbee,Arno W. Hoes
Publisher : Jones & Bartlett Publishers
Release : 2014-01-01
ISBN : 144967433X
Language : En, Es, Fr & De

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Book Description :

Now updated with new data and examples throughout, Clinical Epidemiology: Principles, Methods, and Applications for Clinical Research, Second Edition is a comprehensive resource that introduces the reader to the basics of clinical epidemiology and explores the principles and methods that can be used to obtain quantitative evidence on the effects of interventions and on the diagnosis, etiology, and prognosis of disease. The everyday challenges of clinical research and the quantitative knowledge required to practice medicine are also examined, making this book a valuable reference for both graduate and undergraduate students in medicine and related disciplines, as well as for professionals involved in the design and conduct of clinical research.

Principles and Practice of Research in Midwifery E Book

Principles and Practice of Research in Midwifery E Book Book
Author : Elizabeth R. Cluett,Rosalind Bluff
Publisher : Elsevier Health Sciences
Release : 2006-05-03
ISBN : 0702035181
Language : En, Es, Fr & De

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Book Description :

This title is directed primarily towards health care professionals outside of the United States. Written by authors with clinical and research experience, this book is intended for midwives and student midwives participating in Diploma, Advanced Diploma and first level degree programmes. It aims to increase research awareness and develop the skills of critical appraisal of research evidence that are essential to evidence based practice.

The Principles and Practice of Antiaging Medicine for the Clinical Physician

The Principles and Practice of Antiaging Medicine for the Clinical Physician Book
Author : Vincent C. Giampapa
Publisher : River Publishers
Release : 2012-11
ISBN : 8792329438
Language : En, Es, Fr & De

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Book Description :

This book takes a whole new perspective concerning the approach to treating aging process. Most doctors feel they have no other options but to operate on the physical processes that occur as we grow older. Now, for the first time, there is another scientific approach that impacts on the causes of aging and not just on the effects. The basic principles and practice of anti-aging medicine and age management clearly and succinctly explains the solid scientific research behind doctor Giampapa's revolutionary theories, revealing that a key number of bio chemical processes at the cellular level can be clinically manipulated to successfully improve the physical signs of aging even without surgery. Dr. Giampapa gives the clinical dermatologist and plastic surgeon the knowledge and tools to successfully incorporate anti-aging medicine into their practice. These tools not only improve the longevity of their cosmetic procedures but markedly enhance the quality of life and health that patients can experience. Throughout the book a new concept of aging is built around preserving DNA function and replication. Treatment concepts are centered around: Controlling blood sugar levels and glycation; Inhibiting cellular inflammation; Supplying the correct combination of antioxidants; Improving gene regulation and methylation; Following a simple diet guide and exercise plan; Regulating age-related hormonal declines; Improving DNA repair and decreasing DNA damage. Containing hundreds of scientific medical references as a valuable resource for future investigation and information, this book is an essential addition to the cosmetic physicians library.

Principles and Practice of Pharmaceutical Medicine

Principles and Practice of Pharmaceutical Medicine Book
Author : Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier
Publisher : John Wiley & Sons
Release : 2007-04-30
ISBN : 9780470093146
Language : En, Es, Fr & De

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Book Description :

The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Sharing Clinical Trial Data

Sharing Clinical Trial Data Book
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Release : 2015-04-20
ISBN : 0309316324
Language : En, Es, Fr & De

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Book Description :

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.

Principles and Practice of Clinical Electrophysiology of Vision second edition

Principles and Practice of Clinical Electrophysiology of Vision  second edition Book
Author : John R. Heckenlively,Geoffrey B. Arden
Publisher : MIT Press
Release : 2006-04-07
ISBN : 0262083469
Language : En, Es, Fr & De

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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.

Principles of Clinical Cancer Research

Principles of Clinical Cancer Research Book
Author : Loren K. Mell, MD,Phuoc T. Tran, MD, PhD,James B. Yu, MD, MHS,Qiang (Ed) Zhang, PhD
Publisher : Springer Publishing Company
Release : 2018-11-28
ISBN : 1617052396
Language : En, Es, Fr & De

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Book Description :

Principles of Clinical Cancer Research provides comprehensive coverage of the fundamentals of clinical cancer research, including the full spectrum of methodologies used in the field. For those involved in research or considering research careers, this book offers a mix of practical advice and analytical tools for effective training in theoretical principles as well as specific, usable teaching examples. The clinical oncologist or trainee will find a high-yield, practical guide to the interpretation of the oncology literature and the application of data to real-world settings. Valuable for both researchers and clinicians who wish to sharpen their skills, this book contains all of the cornerstones and explanations needed to produce and recognize quality clinical science in oncology. Written from the physician-scientist’s perspective, the book lays a strong foundation in preclinical sciences that is highly relevant to careers in translational oncology research along with coverage of population and outcomes research and clinical trials. It brings together fundamental principles in oncology with the statistical concepts one needs to know to design and interpret studies successfully. With each chapter including perspectives of both clinicians and scientists or biostatisticians, Principles of Clinical Cancer Research provides balanced, instructive, and high-quality topic overviews and applications that are accessible and thorough for anyone in the field. KEY FEATURES: Gives real-world examples and rationales behind which research methods to use when and why Includes numerous tables featuring key statistical methods and programming commands used in everyday clinical research Contains illustrative practical examples and figures in each chapter to help the reader master concepts Provides tips and pointers for structuring a career, avoiding pitfalls, and achieving success in the field of clinical cancer research Access to fully downloadable eBook

Designing Clinical Research

Designing Clinical Research Book
Author : Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman
Publisher : Lippincott Williams & Wilkins
Release : 2011-11-30
ISBN : 1451165854
Language : En, Es, Fr & De

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Book Description :

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.