Clinical trial design

Summary

Randomized clinical trials (RCTs) are the cornerstone of modern evidence-based medicine. The primary objective of an RCT is to provide unbiased estimates of the comparative efficacy and safety of various treatments and/or interventions. Interventional cardiology has undoubtedly been at the forefront of clinical research, with a multitude of high-quality RCTs that have substantially informed both medical practice and clinical guidelines. However, the overall number of RCTs remains limited, and only a small proportion of medical decisions are currently supported by evidence derived from such trials. This highlights the ongoing need to expand the number of RCTs in modern medicine.

Universal standards of trial design apply to all RCTs in order to obtain sound data to inform practice (https://www.goodtrials.org/guidance). 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

According to current international regulations, medical devices are classified into three classes of increasing risk to patients. In general, devices that are permanently implanted (e.g., coronary stents, cardiac valvular prostheses, pacemakers) are considered high-risk medical devices in both the United States and the European Union.

Table 1. Medical Device Risk Classification by Region