Decentralised clinical trials (DCTs) - the basics
The double-blinded randomised controlled trial has been the gold standard for clinical research since the 1940s. It remains rigorous and well-understood. It is also expensive, slow, and dependent on participants being able and willing to travel to a physical site. More than 37,000 trials are registered worldwide each year, and the operational costs of running them in this traditional model are significant.
Decentralised clinical trials (DCTs) address this by moving the trial to the participant rather than the participant to the trial. Digital platforms, smartphone apps, and wearable devices make it possible to collect data remotely, removing many of the logistical barriers that have historically limited participation and increased costs.
The problems DCTs are designed to solve
Scheduling and travel burden. Traditional site-based trials require participants to attend in person, often repeatedly. This creates real barriers: working patterns, caring responsibilities, distance, and transport costs all contribute to dropout. Remote participation through a digital platform removes this entirely for many data collection tasks.
High staff costs. Participant management in a centralised trial requires substantial administrative resource over extended timeframes. Well-designed DCT platforms reduce this overhead by enabling participants to self-serve for routine tasks without requiring staff time for each interaction.
Data quality problems from manual handling. Transcribing paper records introduces errors. DCT platforms that use validated electronic capture reduce these errors at the point of entry rather than catching them later in cleaning and monitoring.
Geographic restriction. A site-based trial can only recruit from the population close enough to attend. DCT models allow geographically diverse recruitment, which produces more representative cohorts and findings that are more generalisable across populations.
Participant burden. Travel, rigid scheduling, and time commitments reduce engagement and can drive dropout. When participation fits into a participant's own routine rather than requiring them to reorganise around site hours, compliance tends to improve.
The economic argument
Bringing a new therapy to market in the US costs approximately $3 billion. A significant proportion of that cost is in clinical trial operations. DCT approaches do not eliminate this cost, but they shift the balance: less spend on site infrastructure and coordination, more capacity for data collection and participant reach.
The DCT model accelerated significantly during the COVID-19 pandemic, when site-based research became difficult or impossible for extended periods. What emerged was a more permanent shift in appetite for remote and hybrid approaches that continues to develop as regulatory frameworks catch up.