Introduction to decentralized clinical trials: benefits, challenges and solutions
Published on February 28, 2023 17 min
A selection of talks on Pharmaceutical Sciences
Hello. My name is Ada Middleton. I'm a Senior Director in the Patient Innovation Center at Parexel, a contract research organization focused on supporting the development of innovative, new therapies to improve patient health. I'm delighted to provide an introduction to the topic of decentralized clinical trials.
For today's talk, we'll go through a definition of DCTs and speak about why they are important. I'll also talk about the approach to DCT and some key components, also strategy considerations, benefits and challenges, and talk about DCT adoption.
Let's start with a definition. Decentralized clinical trials are defined as studies executed through telemedicine and mobile or local health care providers using processes and technologies differing from the traditional clinical trial model. Within the clinical trials industry, there are many terms used for these types of trials. Virtual, remote, decentralized, site-less, direct-to-patient, direct-with-patient. The term DCT (decentralized clinical trial) is consistent with the FDA preferred nomenclature and is the term that I will use throughout this presentation.
Why are DCTs important? Have a look at the numbers on the slide. As you can see, it is common for study timelines and data to be negatively impacted by recruitment problems and participant dropouts. Contributing to these issues is the fact that the majority of potential participants live more than 2 hours away from their nearest study center. DCTs aim to maximize patient access and experience, focus on data quality, and provide enhanced recruitment and retention options while maintaining or improving costs.