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Doody's Review ServiceReviewer: Cheryl Lynn Nunn-Thompson, PharmD, MBA (University of Illinois at Chicago College of Pharmacy)
Description: This book is a review of global efforts by regulatory agencies and clinical study sponsors to validate and audit clinical study data. Contributors also provide a comprehensive overview of management of quality assurance in clinical trials, Good Clinical Practices (GCP), and management of audit outcomes.
Purpose: According to the editor, the purpose is to "gather the collective expertise of a worldwide group of experts to address the current issues and trends in the validation and auditing or a clinical study." These are worthy objectives, as quality issues in the drug approval process encompass international challenges to build quality assurance into the design of clinical trials. In particular, this is an important book given recent disclosures regarding fraud and misconduct in clinical research; the audit of clinical trial data is important to avoid this problem in future research. The editor has achieved his stated purpose/objectives.
Audience: Although the editor does not specify an audience for this text, it would be suitable for a wide range of individuals involved in either designing or auditing clinical trial data. This would include quality assurance personnel in the pharmaceutical industry or in governmental regulatory agencies, individuals from contract research organizations (CRO), members of institutional review boards (IRB) committees, or clinical investigators. The editor of the text is a consultant in this field; chapters are written by eleven contributors whose expertise appears to be related to the field of quality assurance of clinical trial data. Unfortunately, biographies of these individuals are not provided for the reader.
Features: Overviews of the clinical development process, statutory requirements and regulatory guidance, clinical auditors' observations, quality assurance in clinical trials, standardizing quality in clinical trials, GCP, and computers, Food and Drug Administration (FDA) audits, international assessment of GCP compliance, and fraud in clinical research are all provided in this book. Each chapter contributor provides a general overview of the topic and refers readers to additional sources for more comprehensive and technical information. Each chapter is fairly current in content and minimally referenced; this book does not contain any graphics or tables. An appendix contains a several reference documents.
Assessment: This would be a useful introductory text for individuals involved in the validation and auditing of clinical trial information. The editor provides an international perspective on designing quality into clinical research, covers important sub-topics in the field, and presents the information at a general level.