Decentralized Clinical Trials (DCTs)

Decentralized Clinical Trials (DCTs) are clinical trials in which some or all trial-related activities — participant visits, specimen collection, investigational product (IP) dispensing, or data collection — happen away from a traditional brick-and-mortar investigational site, using telehealth visits, local labs or imaging facilities, direct-to-participant (DtP) drug shipment, and digital health technologies (DHTs) instead. A trial is decentralized to a degree, not as a binary label: FDA and EMA both frame DCTs as a spectrum from “hybrid” (a mix of site-based and remote activities) to “fully decentralized” (no in-person site visits at all), rather than a fixed regulatory category.

What Makes a Trial a DCT

A trial counts as decentralized to the extent it substitutes one or more of the following for an in-person investigational-site visit:

• Telehealth visits — investigator or sub-investigator assessments (informed consent discussions, adverse-event review, eligibility screening) conducted by live video or phone instead of in clinic.
• Local or mobile services — specimen collection, vital signs, or a physical exam performed by a local laboratory, imaging center, mobile health provider, or visiting nurse near the participant, rather than at the site.
• Direct-to-participant (DtP) IP shipment — investigational product shipped to the participant’s home (or a local pharmacy) instead of dispensed on-site, with chain-of-custody and handling procedures adapted accordingly.
• Digital health technologies (DHTs) — wearables, sensors, and apps used to capture data (e.g., an electronic patient-reported outcome, or ePRO, instrument, or continuous physiologic monitoring) remotely instead of during a clinic visit.

Critically, none of this changes the underlying regulatory requirements. A DCT is still subject to the same IND/IDE, Good Clinical Practice (GCP), informed-consent, and safety-reporting obligations as a fully site-based trial — the guidance addresses how to meet those existing requirements when specific activities move off-site, not a separate, lighter-touch pathway.

FDA’s Framework

FDA’s final guidance, Conducting Clinical Trials With Decentralized Elements, was announced via Federal Register notice on September 18, 2024, following an earlier 2023 draft. It applies to trials of drugs, biological products, and devices, and addresses sponsor and investigator responsibilities when trial activities occur at a participant’s home or a local facility, the use of DHTs for remote data collection, IP shipping directly to participants, and the delegation of specific trial-related activities to local health-care providers who are not listed as sub-investigators at the central site. The guidance does not create a new regulatory pathway or approval category for DCTs — it clarifies how the existing framework (informed consent, GCP, adverse-event reporting, IP accountability) applies when a trial is organized this way.

EMA’s Recommendation Paper

In the EU/EEA, the European Medicines Regulatory Network (coordinated through EMA and the national competent authorities, together with the European Commission) published its Recommendation Paper on Decentralised Elements in Clinical Trials on December 13, 2022. It addresses similar ground to the FDA guidance — sponsor and investigator roles and responsibilities, electronic informed consent, IP delivery to participants, trial-related procedures performed at a participant’s home, and data management and monitoring in a decentralized setting — while emphasizing that participant safety and rights protections must be preserved regardless of where a given activity takes place. As with the FDA document, this is recommendation-level guidance interpreting existing EU Clinical Trials Regulation requirements, not a separate legal category for DCTs; specific procedural detail should be confirmed against the current EMA/EC publication, since recommendation papers of this kind are periodically revised.

Worked Examples

• Hybrid DCT: A Phase III hypertension trial where the screening visit and first dose occur at the investigational site, but subsequent follow-up visits alternate between telehealth check-ins with the investigator and a home blood-pressure cuff (a DHT) that transmits readings directly into the trial’s electronic data capture (EDC) system, with study drug refills shipped directly to the participant after the first on-site visit.
• Fully decentralized DCT: A Phase IV post-marketing safety study in a widely prescribed, well-characterized drug where informed consent is obtained via econsent, the participant never visits a physical site, a mobile phlebotomy service draws periodic blood samples at the participant’s home, and all outcome data is collected through an ePRO app — with a local physician available as a point of contact for any adverse event rather than a central investigational site.

Counter-Example

A single-site Phase I trial where every visit, dose administration, and specimen collection occurs exclusively at the investigational site, and the only participant-facing digital tool is an optional post-visit satisfaction survey, is not a DCT — no trial-related procedure has actually moved away from the site. Offering an ancillary web form does not, by itself, decentralize a trial; what matters is whether investigator assessments, IP dispensing, or data collection have been relocated to the participant or a local facility.

Related Terms

See the full guide, Decentralized Clinical Trials (DCTs): What They Are, FDA Guidance, and Key Components, for a comprehensive walkthrough of planning and operating a DCT. Related concepts: Decentralized Clinical Trial (DCT) Platform, eConsent, Electronic Data Capture (EDC), eSource / Electronic Source Data, ePRO, Wearable Devices and Digital Health Technologies (DHTs), Clinical Trial Management System (CTMS), Institutional Review Board (IRB), the Common Rule (45 CFR 46), and ICH E6(R3), whose Annex 2 addresses decentralized and pragmatic trial elements. For IP logistics specifically, see the guide on clinical trial supply management.