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Essentials of Clinical Research

Author: Stephen P. Glasser

Publisher: Springer

Published: 2014-06-02

Total Pages: 461

ISBN-13: 3319054708

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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.

Book Synopsis Essentials of Clinical Research by : Stephen P. Glasser

Download or read book Essentials of Clinical Research written by Stephen P. Glasser and published by Springer. This book was released on 2014-06-02 with total page 461 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Trials

Author: Lawrence M. Friedman

Publisher: Springer Science & Business Media

Published: 1998

Total Pages: 384

ISBN-13: 9780387985862

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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.

Book Synopsis Fundamentals of Clinical Trials by : Lawrence M. Friedman

Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Fundamentals of Clinical Research

Author: P. Michael Dubinsky

Publisher: John Wiley & Sons

Published: 2022-01-26

Total Pages: 554

ISBN-13: 1118949595

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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

Book Synopsis The Fundamentals of Clinical Research by : P. Michael Dubinsky

Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Designing Clinical Research

Author: Stephen B. Hulley

Publisher: Lippincott Williams & Wilkins

Published: 2011-11-30

Total Pages: 388

ISBN-13: 1451165854

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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.

Book Synopsis Designing Clinical Research by : Stephen B. Hulley

Download or read book Designing Clinical Research written by Stephen B. Hulley and published by Lippincott Williams & Wilkins. This book was released on 2011-11-30 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Principles and Practice of Clinical Research

Author: John I. Gallin

Publisher: Elsevier

Published: 2011-04-28

Total Pages: 447

ISBN-13: 0080489567

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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

Book Synopsis Principles and Practice of Clinical Research by : John I. Gallin

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Clinical Research and the Law

Author: Patricia M. Tereskerz

Publisher: John Wiley & Sons

Published: 2012-04-24

Total Pages: 295

ISBN-13: 1118272161

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CLINICAL RESEARCH AND THE LAW The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance on a wide range of issues including: standards and duty of care conflicts of interest establishing clinical trials informed consent research contracts the disclosure and withholding of clinical trial results Clinical Research and the Law comprehensively discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards. This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.

Book Synopsis Clinical Research and the Law by : Patricia M. Tereskerz

Download or read book Clinical Research and the Law written by Patricia M. Tereskerz and published by John Wiley & Sons. This book was released on 2012-04-24 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: CLINICAL RESEARCH AND THE LAW The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance on a wide range of issues including: standards and duty of care conflicts of interest establishing clinical trials informed consent research contracts the disclosure and withholding of clinical trial results Clinical Research and the Law comprehensively discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards. This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.

Medical Research Essentials

Author: Rania Esteitie

Publisher: McGraw Hill Professional

Published: 2014-02-05

Total Pages: 119

ISBN-13: 007178165X

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LEARN THE EFFICIENT, EASY WAY TO CONDUCT MEDICAL RESEARCH PERFECT FOR ANYONE CONSIDERING A MEDICAL RESEARCH PROJECT! This concise handbook tells you everything you need to know about medical research. You will learn how to read, understand, and ultimately perform it. Medical Research Essentials walks you step by step through the entire research process, from how to read and critique an article, to presenting your own data. Filled with flowcharts, algorithms, diagrams, and tables, Medical Research Essentials is like having an experienced mentor at your side! THIS ULTIMATE HANDBOOK FOR INTERPRETING AND CONDUCTING MEDICAL RESEARCH OFFERS CONCISE COVERAGE OF: How to critically read and interpret medical literature The best methods of organizing and analyzing data Potential research projects that can be performed in a limited time frame How to design your own study and acquire funding Understanding and using medical statistics

Book Synopsis Medical Research Essentials by : Rania Esteitie

Download or read book Medical Research Essentials written by Rania Esteitie and published by McGraw Hill Professional. This book was released on 2014-02-05 with total page 119 pages. Available in PDF, EPUB and Kindle. Book excerpt: LEARN THE EFFICIENT, EASY WAY TO CONDUCT MEDICAL RESEARCH PERFECT FOR ANYONE CONSIDERING A MEDICAL RESEARCH PROJECT! This concise handbook tells you everything you need to know about medical research. You will learn how to read, understand, and ultimately perform it. Medical Research Essentials walks you step by step through the entire research process, from how to read and critique an article, to presenting your own data. Filled with flowcharts, algorithms, diagrams, and tables, Medical Research Essentials is like having an experienced mentor at your side! THIS ULTIMATE HANDBOOK FOR INTERPRETING AND CONDUCTING MEDICAL RESEARCH OFFERS CONCISE COVERAGE OF: How to critically read and interpret medical literature The best methods of organizing and analyzing data Potential research projects that can be performed in a limited time frame How to design your own study and acquire funding Understanding and using medical statistics

ESSENTIALS OF CLINICAL RESEARCH

Author: Ravindra B Dr Ghooi

Publisher:

Published: 2016-06-16

Total Pages: 244

ISBN-13: 9789380725093

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Introduction, Glossary& Drug Development Process, Clinical Trials on Drugs, Regulatory Strategy, Regulatory Control Over Drugs, Ethical Aspects of Clinical Research, sponsibility of Stakeholders, Clinical Trial Documents, Endpoints in Clinical Research, Site and Investigator Selection, Subject Recruitment and Selection, Meetings in Clinical Research, Data and Safety Monitoring, IND and NDA, Clinical Data Management, Safety Reporting and Pharmacoviligance, Quality Assurance in Clinical Research, Standard Operating Procedures, Clinical Research Outsourcing, Statistics in Clinical Research, Insurance and Liability, Non-compliance, Misconduct and Fraud, Intellectual Property Rights, Websites for Informa

Book Synopsis ESSENTIALS OF CLINICAL RESEARCH by : Ravindra B Dr Ghooi

Download or read book ESSENTIALS OF CLINICAL RESEARCH written by Ravindra B Dr Ghooi and published by . This book was released on 2016-06-16 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction, Glossary& Drug Development Process, Clinical Trials on Drugs, Regulatory Strategy, Regulatory Control Over Drugs, Ethical Aspects of Clinical Research, sponsibility of Stakeholders, Clinical Trial Documents, Endpoints in Clinical Research, Site and Investigator Selection, Subject Recruitment and Selection, Meetings in Clinical Research, Data and Safety Monitoring, IND and NDA, Clinical Data Management, Safety Reporting and Pharmacoviligance, Quality Assurance in Clinical Research, Standard Operating Procedures, Clinical Research Outsourcing, Statistics in Clinical Research, Insurance and Liability, Non-compliance, Misconduct and Fraud, Intellectual Property Rights, Websites for Informa

Basic Principles of Clinical Research and Methodology

Author: SK Gupta

Publisher: Jaypee Brothers,Medical Publishers Pvt. Limited

Published: 2007-05-30

Total Pages: 516

ISBN-13: 9788184480863

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Book Synopsis Basic Principles of Clinical Research and Methodology by : SK Gupta

Download or read book Basic Principles of Clinical Research and Methodology written by SK Gupta and published by Jaypee Brothers,Medical Publishers Pvt. Limited. This book was released on 2007-05-30 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Essentials of Clinical Research

Author: Stephen P. Glasser

Publisher: Springer

Published: 2009-08-29

Total Pages: 360

ISBN-13: 9789048120161

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This book is designed to provide the “student” interested in clinical research a foundation upon which to build more advanced study. The book focuses on clinical trials, in contrast to the many excellent textbooks that address epidemiological research. With the recent interest in patient oriented research, this book should provide a knowledge base that is not necessarily covered in other texts. Chapters discussing the FDA’s role in clinical research, Data Safety and Monitoring Boards, Postmarketing studies, the use of placebo controls, and a focus on clinical trials illustrates this point. In addition, new types of clinical research are evolving, and as such, this book discusses genetic, pharmacoepidemiologic, and implementation research. Finally, chapters on tips on how to write a grant, the mentoring process, and how to present ones research results are unique to this book.

Book Synopsis Essentials of Clinical Research by : Stephen P. Glasser

Download or read book Essentials of Clinical Research written by Stephen P. Glasser and published by Springer. This book was released on 2009-08-29 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is designed to provide the “student” interested in clinical research a foundation upon which to build more advanced study. The book focuses on clinical trials, in contrast to the many excellent textbooks that address epidemiological research. With the recent interest in patient oriented research, this book should provide a knowledge base that is not necessarily covered in other texts. Chapters discussing the FDA’s role in clinical research, Data Safety and Monitoring Boards, Postmarketing studies, the use of placebo controls, and a focus on clinical trials illustrates this point. In addition, new types of clinical research are evolving, and as such, this book discusses genetic, pharmacoepidemiologic, and implementation research. Finally, chapters on tips on how to write a grant, the mentoring process, and how to present ones research results are unique to this book.