The Fundamentals Of Clinical Research


The Fundamentals Of Clinical Research
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The Fundamentals Of Clinical Research


The Fundamentals Of Clinical Research
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Author : P. Michael Dubinsky
language : en
Publisher: John Wiley & Sons
Release Date : 2022-01-26

The Fundamentals Of Clinical Research written by P. Michael Dubinsky and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-26 with Medical categories.


This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources



Fundamentals Of Clinical Trials


Fundamentals Of Clinical Trials
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Author : Lawrence M. Friedman
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-09-09

Fundamentals Of Clinical Trials written by Lawrence M. Friedman and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-09-09 with Medical categories.


The clinical trial is “the most definitive tool for evaluation of the applicability of clinical research.” It represents “a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments” [1]. It has been called on many occasions, “the gold st- dard” against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2–21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues.



Fundamentals Of Clinical Trials


Fundamentals Of Clinical Trials
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Author : Lawrence M. Friedman
language : en
Publisher: Springer Science & Business Media
Release Date : 1998

Fundamentals Of Clinical Trials written by Lawrence M. Friedman and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998 with Clinical trials categories.


This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.



Fundamentals Of Clinical Research


Fundamentals Of Clinical Research
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Author : Antonella Bacchieri
language : en
Publisher: Springer Science & Business Media
Release Date : 2007-04-29

Fundamentals Of Clinical Research written by Antonella Bacchieri and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-04-29 with Medical categories.


Here is a new book on methods and issues in clinical research. Its objectives can be summarized in three points. 1. Integrate medical and statistical components of clinical research. 2. Do justice to the operational and practical requirements of clinical research. 3. Give space to the ethical implications of methodological issues in clinical research. The book ends with a brief description of the drug development process and the phases of clinical development.



Fundamentals Of Clinical Trials


Fundamentals Of Clinical Trials
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Author : Lawrence M. Friedman
language : en
Publisher: Springer
Release Date : 2015-08-27

Fundamentals Of Clinical Trials written by Lawrence M. Friedman and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-27 with Medical categories.


This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.



Fundamentals Of Clinical Research


Fundamentals Of Clinical Research
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Author : Bacchieri
language : en
Publisher:
Release Date : 2009-12-01

Fundamentals Of Clinical Research written by Bacchieri and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-12-01 with categories.




Fundamentals Of Clinical Trials


Fundamentals Of Clinical Trials
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Author : Lawrence M. Friedman
language : en
Publisher:
Release Date : 1996

Fundamentals Of Clinical Trials written by Lawrence M. Friedman and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996 with Clinical Trials categories.




Essentials Of Clinical Research


Essentials Of Clinical Research
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Author : Stephen P. Glasser
language : en
Publisher: Springer
Release Date : 2014-06-02

Essentials Of Clinical Research written by Stephen P. Glasser and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-06-02 with Medical categories.


In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.



Fundamentals Of Clinical Data Science


Fundamentals Of Clinical Data Science
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Author : Pieter Kubben
language : en
Publisher: Springer
Release Date : 2018-12-21

Fundamentals Of Clinical Data Science written by Pieter Kubben and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-21 with Medical categories.


This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.



All You Need To Know About Clinical Research


All You Need To Know About Clinical Research
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Author : Sanjay Gupta
language : en
Publisher: Dna Press
Release Date : 2010

All You Need To Know About Clinical Research written by Sanjay Gupta and has been published by Dna Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Health & Fitness categories.


This book is intended to provide a comprehensive understanding of the essential clinical trial elements in a concise fashion. It is intended to serve as a quick reference guide to all the personnel involved in the conduct of clinical trials as well as to those who plan to enter this field. Spanning over 167 pages the book provides a thorough compilation on, 1. Fundamentals of Clinical Research 2. Glossary of Clinical Trials Terminology (1052 frequently used terminologies of clinical research) 3. Abbreviations (224 frequently used terminologies of clinical research) 4. Clinical Trial Stakeholders 5. Clinical Study Process 6. Location of Essential Documents Before, During and After Completion of a Clinical Trial 7. Critical Milestones of a Clinical Trial Project 8. Overview of Regulatory Environment in USA, Australia, Europe, UK and India Being the first and only book on this important topic it has fulfilled the unmet need and is of great benefit to all the personnel involved in clinical research.