Pragmatic Trials

Abstract

This chapter explores the role of pragmatic trials in aging research, comparing their characteristics to those of explanatory clinical trials. We additionally conducted an exploratory search of the literature up to February 2024 and identified 1613 records of pragmatic clinical trials involving older adults. There was a decline in publications during the COVID-19 pandemic but an overall increase in trial registrations. The most frequently studied conditions were cancer, pain, and diabetes. Most trials were conducted in high-income countries, highlighting the need to strengthen infrastructure, resources, and collaboration in low- to middle-income countries to conduct pragmatic trials that address the needs of geriatric patients worldwide. Pragmatic trials face unique ethical and methodological challenges, particularly in obtaining informed consent and ensuring the inclusion of older adults in explanatory trials for the subsequent ethical conduction of pragmatic trials. Tools such as PRECIS-2 and the GetReal Trial Tool can aid in designing trials that are both feasible and relevant to real-world practice. Pragmatic trials, with their focus on real-world effectiveness, play a crucial role in bridging the gap between research and clinical practice in the context of aging research.