Decentralized Clinical Trial (DCT)

Key facts

FDA guidance

Conducting Clinical Trials With Decentralized Elements (final, 2024)

Common elements

Telehealth visits, home nursing, direct-to-participant shipping, eConsent

Regulatory standard

Same FDA requirements as site-based trials, including 21 CFR Parts 50 and 312

What is a decentralized clinical trial?

In a traditional trial, participants travel to a site for every visit. A decentralized trial moves some or all of those activities closer to the participant, through telehealth, visits by mobile nurses, local laboratories and health care providers, and investigational products shipped to the home.

Few trials are fully remote. Most use a hybrid model, keeping complex procedures such as infusions or imaging at a site while moving routine follow-up closer to home. FDA refers to these as trials with decentralized elements. Remote methods spread quickly during the COVID-19 pandemic, when many site visits were not possible.

How decentralized trials work

Common decentralized elements include:

• Remote informed consent through electronic consent (eConsent) systems.
• Telehealth visits with the investigator or study staff.
• In-home visits by trained nurses, and use of local health care providers for routine tests.
• Direct-to-participant shipment of investigational products, where the product is suitable for it.
• Digital health technologies, such as wearables and apps, that collect data remotely.

Why decentralized trials matter

Decentralized elements aim to reduce travel burden, which can widen participation among rural patients, people with limited mobility and those who cannot take time off work. They can also speed enrollment by reaching patients far from academic centers.

For trial planning teams, decentralization changes the question from which sites are near patients to which activities can safely happen away from a site. For technology vendors and home health providers, it creates demand among sponsors and contract research organizations.

Limitations of decentralized trials

Decentralized trials must meet the same requirements for investigator oversight, informed consent, Institutional Review Board (IRB) review and data integrity as site-based trials. Practical barriers include state medical licensing rules for telehealth across state lines, shipping limits for some products, participant access to devices and broadband, and the extra work of verifying data captured outside clinical settings.