One of the main reasons why we find clinical trial research to be so rewarding is that it provides a wide array of intellectual challenges, and each trial offers the opportunity to discover answers to real-world research questions. This book is the result of more than 20 years of our experience spent working on dozens of trials. This book is for professionals interested in clinical research, whether they are formulating an investigator-initiated project, managing the clinical trial process, or working within a trial in any role.

This book is divided into key topic areas of research, and each chapter provides a framework and understanding of a fundamental area of a clinical trial. This book is intended to offer practical advice and covers who the key players are, the inner workings of the processes, everyday examples, and related references.

我们发现临床试验研究如此有价值的一个主要原因是，它提供了一系列智力挑战，而且每个试验都提供了发现现实世界研究问题答案的机会。这本书是我们花了20多年的经验，在几十个试验工作的结果。这本书是为对临床研究感兴趣的专业人士，无论他们是制定一个研究员发起的项目，管理临床试验过程，或在任何角色的试验工作。

这本书分为重点研究领域，每一章提供了一个框架和一个临床试验的基本领域的理解。这本书的目的是提供实用的建议，并涵盖谁是关键的球员，内部运作的过程，日常的例子，和相关的参考资料。