Tuesday, July 30, 2013

The Clinical Audit in Pharmaceutical Development

The Clinical Audit in Pharmaceutical Development by Michael Hamrell adds quality to the pharmaceutical clinical development process by detailing the need for, and stressing the importance of, an independent audit of clinical data to protect participants and validate study results.

This book examines the use of personal computers, the Internet, and third-party organizations to assist in data validation! Positioning the audit as the only reliable tool to verify that a drug has been shown to be safe and effective in clinical trials, it recommends establishing auditing and quality assurance at the beginning of a clinical study.

This book describes Good Clinical Practices (GCPs) and the role of regulatory agencies in the review, validation, and auditing processes. It outlines the clinical process, from trial design through report writing, compares and contrasts United States and international regulatory statutes, identifies monitoring as the key to guaranteeing high-quality data and focuses on the role of the clinical audit in achieving unity in a multinational study.

Author discusses the worldwide influence of the US Food and Drug Administration audit, analyzes findings from previous FDA clinical audits to reveal trends and future directions, provides guidelines for fraud detection and considers the ramifications of falsified data and more!

Confirming that all clinical information has been properly collected and reported, it is a crucial reference for clinical and research pharmacists and pharmacologists; biostatisticians; clinical research associates, coordinators, and investigators; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.

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. 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.

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