Decentralised trials, centralised expertise
The promise of decentralised clinical trials is straightforward: reach more patients, run leaner studies, and collect data closer to where people actually live. The harder question is whether operating models are actually built for it.
The hybrid reality nobody warned you about
The FDA's September 2024 final guidance on conducting trials with decentralised elements made one thing clear: most trials are not going to be fully remote or fully site-based. They sit somewhere in the middle, combining on-site visits for clinical assessments with remote data collection, telemedicine check-ins, home nursing, and local lab draws. Running a hybrid trial means managing two operating models simultaneously — and the teams that underestimate this tend to discover it around month four, when query rates start climbing.
What recruitment actually looks like in a remote trial
The case for DCTs often starts with enrolment. Remote access removes the travel burden, expands geographic reach, and in rare disease trials can make the difference between hitting your sample size and not. But recruitment bias does not disappear when the trial goes remote — it moves. Patients without reliable internet access, those uncomfortable navigating digital tools, and communities with longstanding reasons to distrust research institutions do not automatically appear in a DCT. The trials that actually improve diversity do it by design: community partnerships, multilingual recruitment materials, and early engagement with patient advocacy groups.
Regulatory clarity is real. Operational complexity is not going away.
The FDA guidance, alongside the EMA's parallel work, gives sponsors more to work with than they had three years ago. What the guidance cannot do is manage the friction of running across multiple regulatory jurisdictions at once. A trial with sites in five European countries has five different frameworks for telemedicine licensing, five variations on data privacy obligations, five sets of local investigator responsibilities. Knowing the FDA document does not make it navigable. Experience does.
Where the real work lives
Technology vendors sell platforms. Sites contribute patient relationships. Neither of them owns the connective tissue in between: protocol design choices that determine which endpoints are valid when captured remotely, risk-based monitoring frameworks built for decentralised data streams, regulatory correspondence across multiple competent authorities. The DCTs that run into trouble are almost never undone by the technology. They are undone by governance gaps — ownership questions that were left unresolved in setup.
A practical example from Georgia
Consider a patient participating in a cardiovascular study from a regional area outside Tbilisi. A wearable device records an abnormal heart rhythm and automatically transmits the data to the study platform. If responsibilities for reviewing wearable alerts, contacting the patient, assessing clinical significance, and reporting potential safety events have not been clearly assigned, valuable time can be lost while stakeholders determine who should act. The technology functions exactly as intended; the challenge lies in governance, communication pathways, and predefined escalation procedures.
Prepared by Paspigioni team: Marika Gergedava, MD and Nina Biblaia