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Essentials of Clinical Research

Author: Stephen P. Glasser

Publisher: Springer

Published: 2014-06-02

Total Pages: 461

ISBN-13: 3319054708

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.

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

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.

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

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

Understanding Clinical Research

Author: Renato D. Lopes

Publisher: McGraw Hill Professional

Published: 2013-05-22

Total Pages: 262

ISBN-13: 0071792651

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A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials

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

Foundations of Clinical Research

Author: Leslie Gross Portney

Publisher:

Published: 2015

Total Pages: 0

ISBN-13: 9780803646575

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Draw upon the foundations necessary for finding and interpreting research evidence across all healthcare professions. Revised to reflect the most current changes in the field of clinical research in rehabilitation and medicine, you'll find a growing emphasis on evidence-based practice (EBP) as well as new vocabulary that is being integrated into research and practice across disciplines.

All You Need to Know about Clinical Research

Author: Sanjay Gupta

Publisher: Dna Press

Published: 2010

Total Pages: 1

ISBN-13: 8190827715

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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.