The Fundamentals of Clinical Research - by P Michael Dubinsky & Karen A Henry (Hardcover)

About the Book

"Over the last 15-18 years good clinical practice (GCP) has emerged as the framework, from the standpoint of ethical and regulatory expectations, for the conduct of biomedical clinical studies in humans. GCP is mentioned in all existing clinical trial texts, manuscripts, papers, and presentations and it has become law in a number of global regions and countries. GCP provides a practical framework for clinical trial professionals to work within and guides them to abide by regulatory requirements. In turn, the regional and country regulatory authorities integrate GCP into their clinical trial regulations, adopt it to their existing regulations, or utilize it as guidance / best practice"--

Book Synopsis

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

From the Back Cover

A comprehensive reference and guide on the implementation of good clinical practice (GCP) in clinical trials

Good clinical practice (GCP) is the ethical and regulatory framework for conducting biomedical clinical studies in humans. GCP has been implemented in the US, the EU, Japan, and many other global regions and nations--clinical research professionals are required to fully integrate GCP in the planning, execution, monitoring, analysis, and reporting of clinical trials. Written by authors with decades of experience in the field, The Fundamentals of Clinical Research: A Universal Guide for Implementing Good Clinical Practice provides expert guidance on the regulatory, scientific, administrative, business, and ethical aspects of the application of GCP in clinical trials.

Reflecting current ICH-GCP guidelines, this up-to-date volume describes drug development in the regulatory environment, defines the roles and responsibilities of the different players involved, discusses quality systems and procedures in clinical research, and more. Detailed chapters address key topics such as study design for GCP, trial management, resourcing and outsourcing, risk assessment, human subject protection, data collection, and regulatory authority inspection. The text offers a range of pedagogical features such as chapter objectives and content summaries, and includes self-review questions at the end of each chapter. Covering the various disciplines, stages, and best practices of clinical research, this authoritative guide:

• Describes how to successfully implement clinical trials that meet research, regulatory, GCP, and ethical objectives
• Presents a thorough overview of the clinical trial industry and the fundamentals of clinical research
• Covers the history of GCP, the present-day GCP framework, GCP for the individual clinical trial, GCP in the context of drug development, and improving the quality and outcomes of clinical trials
• Includes plates that visually summarize the content and allow readers to cross-reference details in relevant chapters
• Offers a companion website containing supplemental teaching and learning resources

The Fundamentals of Clinical Research: A Universal Guide for Implementing Good Clinical Practice is a must-have reference for clinical research scientists and managers, biostatisticians, pharmacologists, clinical research associates, data management personnel, clinical coordinators, and regulatory personnel involved in clinical trials of drugs, biologics, and medical devices. It also serves as an ideal textbook for educational programs covering clinical trial design, clinical research, and regulatory affairs.

About the Author

P. Michael Dubinsky has more than forty years of experience in the field of GxP quality and compliance in government and industry. He has worked with the FDA and as a regulatory consultant for private corporations. He was also an Instructor in the areas of clinical trial compliance, regulatory audits, and quality at the University of California Berkeley Extension Programs.

Karen A. Henry has worked as a clinical research professional since 1990. She has expertise in regulatory medical writing, standards and processes, trial management and monitoring, biostatistics, and data management. She is also a Lead Instructor for the Certificate Program in Clinical Research Conduct Management at the University of California Berkeley Extension Programs.