Developing a World Class Clinical Trial Site

Abstract

Developing a World Class Clinical Trial Site: A Step by Step Guide for Developing a Clinical Trial Site by P. K. Julka. 2011 Field Creation of a clinical trial site with a focus on drug development. Format Paperback and Kindle eBook available for purchase online. Audience Inexperienced clinical investigators. Purpose Overview of the clinical trial process from design to publication. Content This book is organized into 26 brief chapters that serve as a broad overview of the development of a clinical trial site. Important trial design and implementation concepts, such as review of ethical requirements, creation of standard operating procedures, composition of the study team, infrastructure requirements, and trial monitoring, are provided in pithy and easy-to-follow text. The flow charts and graphics included throughout the book are clear and mostly helpful, and each chapter concludes with several summary points. The last few chapters include templates for common documents, including clinical study reports and publications. Strengths The book is easy to navigate and covers many major topics of interest to novice clinical investigators. Limitations and Weaknesses Although the short book covers many topics that are useful for trial site initiation, the focus of book’s content is on drug discovery and development, with little guidance on other types of clinical trials. It is also primarily designed for inexperienced investigators and would not serve the needs of those investigators who have previously participated in clinical trials. In addition, subjects such as observational trials, implementation science, and investigator-initiated studies are not covered in this textbook. The book also appears biased toward the development of clinical trial sites in India, which may prove annoying to investigators from other locations. Finally, this edition has content unchanged from the 2009 book but has a new title and publication date. Competing Products • Friedman, Furberg, and DeMets. Fundamentals of Clinical Trials. 2010. • Liu and Davis. A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim. 2010. • Brody. Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. 2011. • Meinert C. Clinical Trials: Design, Conduct and Analysis, 2nd ed. 2012. Funding Not reported.