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On behalf of our colleagues and contributors, we are pleased to present this volume. Understanding Clinical Research aims to bridge the gap between “cookbooks” and “textbooks” on clinical research—to strike a balance between providing practical information for application as well as broader perspectives that support advancing the field through scholarship.

The first section, Evolution of Clinical Research, places the evolution of the clinical research enterprise in context, from its beginnings in simple everyday observations to its current status as an invaluable global scientific tool. Included in this section are discussions of the rise of information technologies and the academic research organization as integral parts of the research process and the increasing emphasis on and challenges in the ethical conduct of clinical studies.

In the second section, Principles of Clinical Experimentation, readers will find a comprehensive but concise overview of typical phases of clinical research in the development of medical products, from initial exploration of therapeutic effects to monitoring after marketing approval. A standout chapter in this section is devoted to the importance of conducting clinical studies in the pediatric population, which has often been underemphasized in the contemporary literature.

The book's concluding section, Observational Research, reviews the underlying principles, pitfalls, and best practices regarding the conduct of case-control studies, cohort studies, registries, and subgroup analyses within randomized trials. Given the important preponderance of this type of research, especially in an era of “big data” and comparative effectiveness, an informative review of this topic should prove to be of particular value to current and future researchers.

It is our hope that this book can serve as a useful guide for initial reference as well as a springboard for additional investigation. It should also serve as a tribute to the numerous faculty, staff, fellows, and students who have contributed their many talents over the years to make the Duke Clinical Research Institute an outstanding living laboratory for the ongoing conduct and continued study of clinical research and education.

Renato D. Lopes, MD, MHS, PhD
Robert A. Harrington, MD
February 2013

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