Kieran Connolly
A member of the Decentralized Trial Working Group with the Association of Clinical Research Organizations (ACRO)
Kieran Connolly is a member of the Decentralized Trial Working Group with the Association of Clinical Research Organizations (ACRO). This working group has developed a series of tools to facilitate implementation of decentralized clinical trials.
For decades, clinical trials have primarily taken place in hospitals and specialised centres, known as “sites”. Patients visit these sites for regular appointments, medication administration, and tests. That’s not easy, especially for studies involving children or elderly participants, and families often report that even short appointments can require hours of preparation both on the day and in advance.
Enter decentralised trials (DCTs), which bring the trial to the patient by utilising local healthcare providers, digital health technologies, and telemedicine to conduct activities outside traditional sites. At the heart of this shift is patient-centricity — the idea that research should integrate into people’s lives rather than disrupt them. The concept isn’t new, but technology now makes it easier to engage patients at home with apps for symptom tracking, wearable sensors, and secure video consultations becoming part of modern trial design.
The theory is compelling. More patient-friendly trial designs could attract a wider range of participants and make taking part easier. This would aid recruitment and reduce mid-study withdrawals, leading to faster start-up and completion. Real-time data collection allows trial sponsors to identify issues early, potentially accelerating access to life-saving new therapies. So, why aren’t all trials conducted this way?
The decentralised model introduces challenges. It requires a major change in how sites and research teams manage trials. Home environments aren’t always ideal — assessments and technologies can be complicated, and some participants feel uneasy allowing strangers into their homes, especially elderly or vulnerable patients. Technology can raise concerns around data privacy and security, particularly as privacy laws vary across regions, and regulations continue to evolve. While agencies like the U.S. FDA have issued guidance for DCTs, others have not, creating uncertainty and inconsistencies that complicate global studies.
More patient-friendly trial designs could attract a wider range of participants and make taking part easier.
Fortunately, DCTs are not an all-or-nothing solution. In practice, hybrid trials — combining remote and on-site elements — are becoming commonplace. Patients may log symptoms in an app, use wearables, or take routine measurements such as blood pressure at home then visit a clinic for specialist assessments and tests.
The key is to design studies around the patient journey: understanding who the participants are, what type of interactions suit them, and how to balance remote and in-person care. The future of clinical research may not lie entirely in hospitals or homes, but somewhere in between — making participation easier and bringing life-saving medicines to those in need, faster.
