Decentralized Clinical Trial
A trial that uses telehealth, home-based assessments, wearables, and direct-to-patient logistics to reduce or eliminate site visits.
Definition
A Decentralized Clinical Trial (DCT) executes some or all trial activities, consent, screening, assessments, drug or device delivery, data collection, outside traditional brick-and-mortar investigator sites. Common DCT components include eConsent, telehealth visits, home health visits, direct-to-patient shipping of investigational product, wearable and connected sensor data capture, and ePRO. FDA issued a draft DCT guidance in May 2023 and finalized it in September 2024.What this means in practice
DCT components are now standard tools rather than the experimental exception. MedTech-specific DCT use cases include long-term wearable monitoring and remote device-data collection where home use is the actual indication.- •Treating DCT as a cost-cutting measure rather than a design choice that can either improve or harm data quality depending on execution.
- •Underestimating eConsent regulatory and human-factors validation requirements.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsInternational standard for the design, conduct, and reporting of clinical trials.
Voluntary, informed agreement to participate in research after disclosure of risks and benefits.
Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data.
More in Clinical & Trials
· Same categoryTrial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Any untoward medical occurrence in a subject, whether or not related to the device.
Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available).
An IVD's ability to detect small quantities of an analyte.
Primary references
3 sources- 1
FDA, Decentralized Clinical Trials Guidance (2024)VerifiedFDAfda.gov
- 2
EMA, Recommendation Paper on Decentralised Elements in Clinical TrialsVerifiedEMA / EChealth.ec.europa.eu
- 3
ICH GuidelinesVerifiedICHich.org
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