Reputable Health put together this practical guide for health and wellness brands and ingredient manufacturers: what decentralized clinical trials and real-world evidence are, when they fit, and how to design a study that holds up.
What is a decentralized clinical trial?
A decentralized clinical trial (DCT) moves some or all study activities out of a clinic and into participants’ daily lives: remote consent, shipped product, wearables, at-home lab kits and digital questionnaires. The US FDA issued guidance on conducting clinical trials with decentralized elements in 2024.
Source: FDA, “Conducting Clinical Trials With Decentralized Elements,” guidance, September 2024.
What is real-world evidence?
Real-world data (RWD) is health data collected outside controlled sites, such as wearable readings or health records. Real-world evidence (RWE) is the clinical evidence drawn from analyzing that data. FDA defines both in its RWE framework.
Source: FDA, “Framework for FDA’s Real-World Evidence Program,” 2018.
Why it fits consumer health
Real use
Supplements, functional foods and wearable-tracked outcomes like sleep are used at home. Measuring them there reflects real use.Objective data
Wearables capture continuous measures such as sleep stages and heart rate variability, alongside validated surveys.Reach
Remote recruitment can reach participants beyond one clinic’s radius.DCT vs traditional site-based trial
| DECENTRALIZED | SITE-BASED | |
|---|---|---|
| Where data is collected | Home, wearables, at-home kits | Clinic visits |
| Best for | Sleep, stress, energy, metabolic and other everyday outcomes | Procedures needing in-person clinical assessment |
| Watch-outs | Device compliance, data quality checks, remote identity verification | Recruitment speed, participant burden, cost |
How to design a DCT that holds up
- Start with the claim. Write the claim you want to make, then pick the endpoint that would support it.
- Choose validated measures. Use validated questionnaires and devices with published validation work.
- Pick the right design. A pilot to test a signal, or a controlled study to substantiate a claim.
- Get IRB review. Independent ethics oversight applies to decentralized studies too.
- Pre-specify the analysis. Lock the analysis plan before data comes in.
- Report honestly. State what the evidence supports and where its limits lie.
For ingredient manufacturers
A study on a branded ingredient can give every finished-product brand that uses it a reference point. Design it around the doses and formats your customers actually use.
Virtual clinical trials
A virtual clinical trial is a fully remote form of a decentralized trial: participants enroll, consent, receive product, complete check-ins and report outcomes without visiting a study site. A hybrid trial keeps some in-person visits, for example a lab draw or a baseline exam. For most consumer health studies on supplements, functional foods and wellness products, a fully virtual design is practical because the product is used at home and the outcomes, such as sleep, energy or stress, can be measured there.
Virtual does not mean less rigorous. The same rules apply: a written protocol, ethics (IRB) review, informed consent, a pre-specified primary outcome and, where it fits, randomization and a placebo or control group. Reputable Health designs virtual and hybrid studies for health and wellness brands and ingredient manufacturers, choosing the format based on the claim you want to support.
Clinical trial apps
A clinical trial app is the participant’s main touchpoint in a decentralized study. A good study app typically handles:
- Screening and electronic informed consent (eConsent)
- Daily or weekly questionnaires (electronic patient-reported outcomes, or ePRO)
- Reminders for product use and study tasks
- Syncing data from connected wearables such as rings, watches and fitness trackers
- Secure messaging with the study team
For sponsors, the app is also where data quality is won or lost: clear reminders improve adherence, time-stamped entries reduce recall bias, and wearable sync captures objective measures between check-ins. Participants in Reputable Health studies use the Reputable app, which you can see on our join a study page.
FAQ
What is a decentralized clinical trial?
A study that runs some or all activities away from a traditional site, using remote consent, wearables, at-home kits and digital surveys.
What is real-world evidence?
Clinical evidence drawn from data collected in everyday life.
Can supplement brands and ingredient manufacturers use DCTs?
Yes, with a defined endpoint, IRB oversight and a pre-specified analysis plan.