Preface
Goal
Since 1996 the emergence of the good clinical practice (GCP) framework for the conduct of clinical trials, more than any other requirement or guidance, has served as a singular reference point for performing trials in humans in conformance with ethical and regulatory expectations. Certainly GCP is mentioned and described in all clinical trial texts, manuscripts, papers, and presentations, and it has moved beyond the role of guidance and become law in a number of global regions and countries: the GCP guidance document developed and published by the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has been adopted into law in both the European Union (EU) and Canada, and the World Health Organization has developed a set of GCPs for its constituency. For medical device products, the ISO standard 14155 was revised in 2011 and now serves as the GCP reference point for device‐related clinical research. That step eliminated the need for clinical investigators studying medical devices to debate whether they should be following the ICH‐GCP that was targeted at pharmaceutical drug studies. As a result, GCP has become the universal language of trials that involve human subjects.
GCP provides a framework for clinical trial professionals to work within and guidance in how to abide by their local, national, and/or regional regulatory requirements. In turn, regional and national regulatory authorities integrate GCP into their clinical trial regulations, adopt it to their existing regulations, or call their regulations GCP. The regulatory authorities have established requirements that govern the conduct of trials, and these requirements represent the baseline for compliance. That said, much of the interpretation of the requirements is left to the trial sponsor, investigator, and clinical teams.
The authors, based on their experience both on the job and as teachers, recognize that a comprehensive and integrated understanding of the clinical trial process, with a firm grasp of the fundamental concepts, is vital to improving the quality and outcomes of clinical trials. Both seasoned and novice clinical research professionals wish to obtain a complete overview of the industry and would benefit from learning the fundamentals of clinical research. The comprehensive overview we present in this text will give professionals insight into why they do what they do and provide an integrated understanding of the various disciplines and stages of clinical research. This vantage point allows for judicious application of GCP in practice.
We have designed this text to be used as source material in educational settings such as university courses and as a training aid for the clinical research industry. Our goal is to provide a universal working reference for all of the players in clinical trials: an educational resource that integrates the fundamentals of clinical research for working individuals, clinical research students, or any curious person. By “working individual,” we mean everyone from the novice to the seasoned clinical research professional in academia, industry, or a regulatory environment. From a practical viewpoint, this text has been written to address the regulatory, scientific, administrative, business, and ethical considerations of clinical research trials within a GCP framework. It describes how to implement clinical research to meet research, regulatory, and ethical objectives, such that the process succeeds the first time and does not need to be repeated.
Scope of this Book
Clinical research has reached global proportions. This text will not attempt to touch on each individual country, but rather will look at global regions and nations, such as the EU and the United States, which set the pace for the implementation of GCP worldwide. We have aimed to give perspective to each element of GCP from as many vantage points as we can, and have expanded our discussion of the elements of GCP to include regulatory, scientific, technological, site investigator, sponsor, quality, and IRB viewpoints, as appropriate.
We have focused the scope of our clinical research discussion on trials involving humans in a biomedical context. From an investigative product/test article perspective, the text favors pharmaceutical drugs since they are associated with the majority of clinical trials. Biological products fit into the same niche. We have also addressed medical devices, though we recognize that despite the similarities in areas such as regulatory controls in the United States, there is a plethora of differences. While we cannot discuss all of these differences, we have highlighted some of the most significant ones.
How to Use this Book
This text is divided into sections that contain relevant chapters on the history of GCP, drug development in the regulatory environment, the GCP framework, GCP for the individual clinical trial, and quality in clinical trials. Each chapter builds on a key GCP concept and contains chapter objectives, content, a summary, and a set of knowledge check questions so that the reader can self‐check their learning and comprehension. The ICH‐GCP Guidelines serve as the glossary of terms and definitions. Plates visually summarize the content for certain chapters, and the reader is also able to cross‐reference details in pertinent chapters from the plates. Figures, tables, and other illustrations also enhance the text materials.
Opinion of the Authors
The authors of this text have a combined approximately 76 years of experience working in various areas of clinical research, as well as approximately 25 years of experience as part‐time instructors in university‐sponsored classrooms and online courses of study designed to introduce students to the clinical research industry. They have also developed some of the educational and learning materials that make up these university‐sponsored courses. This text is written from their individual viewpoints as they have interpreted and applied the GCP Guidelines. Except for direct references to the ICH E6 (R2) Guideline or other sources, all statements are the opinions of the authors.
The authors would like to thank Kay Ranganathan for introducing them to the instructional arena for clinical research; their esteemed colleagues for their review of the manuscript; and their families for their patience and support through the times when writing this book got in the way of family life.
About the Authors
P. Michael Dubinsky has more than 40 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.
About the Authors
This book is accompanied by a companion website.
www.wiley.com/go/dubinsky/clinicalresearch
This website includes:
Solutions to the Problems
Further References Section
Protocol Synopsis and Schedule of Trial Activities Template
