Principles and practice of clinical research. (Fourth edition)

The 4th edition of this highly-regarded work has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research.  New to this edition, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines and "omic" platforms, this edition contains new chapters devoted to electronic health records and informational resources for clinical researchers, as well as the many opportunities associated with big data.  Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting human research.

• Written and edited by experts in the field and dedicated to facilitating the translation of scientific research from bench to bedside and back
• Provides expanded coverage of global clinical research
• Contains hands-on, practical suggestions, illustrations and examples throughout
• Includes four new chapters devoted to international regulations of drugs and biological products, the importance and use of electronic health records in clinical research, informational resources for the clinical researcher and advances in access and utility of large data networks and research