Review article: Primer for clinical researchers on innovative trial designs for emergency medicine

Abstract

Randomised trials have long been recognised as the gold standard research tool for evidence-based medicine. The past decade has seen the emergence of several innovative trial designs that are revolutionising how trials are conducted. These innovative designs enable more efficient, pragmatic trials that can address complex research questions which were previously not possible. In this paper, we provide an overview of the key innovative designs that are likely to be useful in the emergency medicine context, namely cluster crossover and stepped wedge designs, sequential multiple assignment randomised trial (SMART) designs, and platform trials. We describe the main features of each design, outline their pros and cons, and describe when they may or may not be useful. We also provide examples of these innovative designs in contexts that are relevant to emergency medicine.