Decentralized and virtual clinical trials explained

What they are

A decentralized clinical trial lets you do some or all study activities from home instead of at a research site.

"Virtual" usually means almost everything happens remotely. "Hybrid" studies mix a few site visits with remote activities.

How remote visits work

Remote parts of a study can include video visits, apps or online questionnaires, wearable devices, and home visits from a nurse.

Study medicine may be shipped to your home, and some lab work can be done at a local lab or by a visiting nurse. Consent may be done electronically, with a team member available to answer questions.

Possible advantages

Decentralized trials can mean less travel, fewer missed workdays and, in some studies, a chance to join even if you live far from a research center.

They may also make studies easier for people with mobility challenges or caregiving duties.

Possible drawbacks

Drawbacks can include less face-to-face contact, the need for reliable internet or a smartphone, and managing devices or shipments at home.

Some tests still require a site visit. Ask what happens if a device stops working or you need help outside of scheduled visits.

Safety and oversight

Decentralized trials follow the same ethics and safety rules as site-based trials, including review by an IRB. You will still have a study contact to call, and the team still monitors side effects.

Questions to ask

Which visits are remote and which are in person? What equipment will I need, and is it provided? Who do I call if I have a problem? How is study medicine delivered? Are there costs for internet or travel? Who can see the data my app or device collects?

Browse related trials

• Depression trials
• Type 2 Diabetes trials
• Hypertension trials

Quick answers

What is a decentralized clinical trial?

A decentralized clinical trial lets you do some or all study activities from home instead of at a research site.

How do remote clinical trial visits work?

Remote parts of a study can include video visits, apps or online questionnaires, wearable devices, and home visits from a nurse.

What are the benefits of a virtual clinical trial?

Decentralized trials can mean less travel, fewer missed workdays and, in some studies, a chance to join even if you live far from a research center.

What are the downsides of a virtual clinical trial?

Drawbacks can include less face-to-face contact, the need for reliable internet or a smartphone, and managing devices or shipments at home.

Sources

• FDA — Conducting Clinical Trials With Decentralized Elements
• 21 CFR Part 56 — Institutional Review Boards