In this book’s 24 chapters, clinical research practitioners share their thoughts on important aspects of clinical trial conduct at the beginning of the new millennium. Each contribution to the compilation is about 20 pages long and easily read on its own, making the book a good travel companion.

The first pages provide a brief overview of the drug development process. They are followed by papers on regulatory, ethical, and liability issues. Subsequent chapters address general clinical trial design, specifically Phase 1 and Phase 4 projects. The next 100 pages discuss protocol writing, case report form (case record form) design, clinical trial supplies, investigator selection, and site monitoring. These are followed by chapters on pharmacovigilance and pharmacoeconomics, and one chapter each on data management, statistical thinking, and project management. Further chapters provide insight into effective communication, audits and inspections, the trial master file and archiving, outsourcing of clinical research, biotechnology and medical devices, and, finally, fraud.

The contributions are solidly researched and informative. They read well, providing a good refresher for seasoned professionals. The book does not provide easy-to-follow, quick-fix checklists, but rather comprehensive narratives on contemporary clinical research practice. More diagrams, tables, and flow charts might have made the visually inclined reader’s task easier. To make the book better suited to novices in clinical research, concrete examples would have helped. A bias toward the situation in the United Kingdom is undeniable, but experienced professionals will readily excuse this and recognize the corresponding processes or institutions in their own countries.

This book can be highly recommended for experienced clinical research professionals who wish to broaden their horizons and are keen on keeping up-to-date with some of the changes—regulatory, procedural, and strategic—that the industry faces at the beginning of the new millennium.

Uwe Gudat, MD, is president of Aretaeus sàrl, Geneva, Switzerland.