Should you adopt the way of the DCT?

Decentralised clinical trials (DCTs) have been growing steadily as a model, accelerated in part by the shift toward remote working that followed the COVID-19 pandemic. Many tasks that previously required a site visit can now be completed remotely, and research organisations have started to notice.

But DCT is not always the right answer. Before committing to a change in model, there are some honest questions worth working through.

Do you actually need to change?

Start with the simplest question: if your current approach is working well, what problem would DCT solve? In some studies, biological samples need to be collected on-site. If participants are coming in anyway, collecting other information during the same visit may be more practical than asking them to use a remote system for separate tasks. "Don't fix what isn't broken" applies here as much as anywhere.

Are your SOPs ready for it?

Most research organisations have standard operating procedures built around a site-based model. Adapting those for a decentralised approach takes time and effort. Under-resourced teams sometimes skip this step, relying on SOPs that are "close enough." That tends to create gaps in training, inconsistencies in how protocols are followed, and problems that show up during monitoring.

What are the regulatory requirements?

This question has a more settled answer than it used to. For several years, DCT regulatory guidance existed mainly as draft documents and evolving expectations, which made it genuinely difficult to build infrastructure with confidence. That changed when the FDA finalised its guidance on conducting clinical trials with decentralised elements, covering drugs, biological products, and devices. The final version clarified expectations around data variability across decentralised collection points, the qualifications required of local healthcare providers involved in remote visits, and the need to maintain a physical location available for inspection even when most trial activity happens remotely.

That doesn't mean the picture is fully settled everywhere. Requirements can still vary by jurisdiction and study type, and EMA guidance continues to develop in parallel rather than in lockstep with the FDA's position. If your DCT design involves collecting data through participant-owned devices or conducting remote clinical assessments, it is still worth engaging with the relevant regulatory body early to confirm your approach is acceptable before you build your infrastructure around it, but there is now considerably more settled ground to build on than there was even two years ago.

What technology infrastructure do you need?

A DCT model typically requires technology that a site-based model does not: remote data collection platforms, participant-facing apps, secure video consultation tools, electronic consent, and potentially integrations between all of these. Understand what you already have, what needs to be added, and what the total cost looks like. Sometimes the technology investment is justified by reductions in staff time and site costs; sometimes it is not.

How will you train staff?

Remote working brings its own security challenges. Staff comfortable with casual remote setups may not be accustomed to the levels of data security required in clinical research. Training should cover system security, login procedures, password policies, and two-factor authentication from the ground up rather than assuming prior knowledge. The most common point of vulnerability in any digital system is the human using it.

What does this mean for participants?

Participants will need to interact with your DCT systems directly, often without any in-person support. If the setup is confusing or unreliable, retention will suffer. A well-designed participant interface with clear instructions, and a genuine support pathway for people who struggle, is not optional: it is what makes the DCT model viable in practice. Simpler is almost always better.

The six questions at a glance

None of these questions have to produce a "no" to be worth asking. The point is making sure the answer to each one is a deliberate choice rather than an assumption carried over from how things have always been done.