Introduction to Surgical Trials

Filling a gap in literature, this book examines surgical trials with a special focus on the underlying principles, challenges, and best practices to successfully conduct rigorous surgical research.

While randomized controlled trials (RCTs) remain the gold standard for evaluation of the safety and efficacy of most medical interventions, they are particularly difficult to implement successfully in the context of surgery. As a result, recruitment rates are often extremely low, crossover from non-operative to operative is common, and patients randomly allocated to surgery often simply decline to have the procedure. All of these challenges call into question the recent generalizability and fundamental quality of traditional surgical RCTs.

As such, this book explores advanced alternative trial design methods and describes the current regulatory environment around the world. Designed as a practical guide, it is a valuable tool for surgeons, epidemiologist and biostatisticians involved in this challenging field.

• Unique book dedicated exclusively to surgical trials
• Describes the most advanced trial methodologies
• Offers an overview of underlying principles, challenges and best practices in the context of surgical trials

CONTENTS

Front Matter

Trial Design

Conducting a Trial

Trial Completion

Regulatory Standards

Alternatives to the Classic RCT