Clinical trial design

Summary

A major factor in the rapid advancement of the field of cardiovascular medicine in recent years has been the refinement in clinical research methodology and thorough evaluation of new technology. In many ways, interventional cardiology has led the way in translational clinical research, in a constant effort to improve technology and patient outcomes with its multitude of high quality clinical trials forming the basis for evidence-based medical practice and informing practice guidelines.

Investigator-initiated clinical trials, particularly those that compare treatment strategies, may be particularly important to define comparative effectiveness for medical decision making. Universal standards of trial design apply to all clinical trials in order to obtain sound data to inform practice.

In this chapter, we review some of the principles of clinical trial design and implementation, illustrating these with examples from recent trials in interventional cardiology.

Introduction

In the United States, the Food and Drug Administration (FDA) regulates the market approval of new interventional medical devices based on scientific evidence that there is reasonable assurance that the medical device is both safe and effective. This Pre-Market Approval (PMA) is the most stringent type of device marketing application required by the FDA and the approval is based on a...