Decentralized Clinical Trials: What The Evidence Shows, and When Remote Elements Help Enrollment

A decentralized clinical trial moves some or all study activities away from the research site: telehealth visits, local providers, remote consent, direct shipment of the investigational product. That is the definition the FDA settled in its September 2024 final guidance [1]. Tufts CSDD estimates $20 million in added expected net present value per drug entering phase II when decentralized methods run through phases II and III, a sevenfold return on setup cost [2]. That gap between what is modeled and what is measured runs through most of what gets published on this topic. Refero's benchmarks page covers how long enrollment actually takes and why it slips; this page asks whether moving activity off site changes enrollment speed, who enrolls, or who stays. Refero does not run trials or recruit participants; it vets and matches the agencies that do, so what follows is written for the person deciding whether a protocol needs any of this.

Decentralized clinical trial statistics at a glance

Every figure below is sourced under Sources at the foot of this page.

• The FDA's final guidance on decentralized elements took effect in September 2024, mandated by the Food and Drug Omnibus Reform Act of 2022 [1].
• A Tufts CSDD model puts decentralized methods in phase II and III trials at $20 million in added expected net present value per drug entering phase II, a sevenfold return on setup cost [2].
• CHIEF-HF randomized 476 heart failure participants in a fully decentralized design with no in-person contact at any point [3].
• The Apple Heart Study enrolled 419,297 participants remotely in about eight months; it was observational, so the figure shows reach rather than a randomized enrollment rate [4].
• About 20% of the US population has neither broadband internet nor a smartphone, and the gap is wider among older, rural, lower-income, and minority groups [5].

What is a decentralized clinical trial?

A decentralized clinical trial (DCT) is a trial in which some or all activities happen away from a traditional research site: a participant's home, a local clinic, or a digital tool that collects data remotely. The FDA guidance does not define a new trial type; it defines a set of optional elements a sponsor can add to an otherwise standard protocol, including telehealth visits, local health care providers, electronic consent, direct-to-participant shipment of the investigational product, and digital health technologies [1]. Most trials using decentralized elements are not fully remote.

The NIH Pragmatic Trials Collaboratory draws the distinction sponsors plan around: a hybrid trial keeps procedures that need direct supervision, such as blood draws and imaging, at the research site, and moves lower-acuity activity off it, including questionnaires, check-ins, and routine follow-up [8]. The FDA guidance holds hybrid designs to the same investigator oversight standard as fully remote ones [1].

What the FDA guidance requires that touches recruitment

The FDA's September 2024 final guidance does not change who may enroll in a trial. It fixes who is responsible for each remote activity, and that allocation shapes what a sponsor can ask a decentralized element to do for recruitment [1].

Four requirements carry the most weight for a recruitment plan. The investigator keeps oversight of every trial activity regardless of where it happens, including tasks delegated to a local provider or vendor. Local health care providers may perform only tasks that do not require detailed knowledge of the protocol or investigational product, and that they are already qualified to perform in ordinary practice. Remote informed consent needs IRB approval of the consent process itself, not just the consent form [1, 9]. Direct-to-participant shipment of the study drug is permitted, but the sponsor keeps accountability for temperature control and product handling [1]. A companion 2023 guidance covers digital health technologies that collect trial data remotely, requiring each device to be validated as fit for the specific purpose the protocol assigns it [10].

Does decentralization speed enrollment? What the evidence shows

The largest enrollment numbers on record come from trials built to be remote from the start, and each carries a design caveat. CHIEF-HF randomized 476 heart failure participants in a fully decentralized design with no in-person contact; enrollment closed early for sponsor-priority reasons rather than a shortage of eligible participants [3]. The Apple Heart Study enrolled 419,297 participants remotely in about eight months, but as an observational study with no randomization, the figure shows reach rather than a comparable enrollment rate [4]. ADAPTABLE randomized 15,076 participants identified largely through electronic health records, the design closest to what a typical sponsor runs, and it still required a health system already holding the eligible population [11]. The modeled financial case, $20 million and a sevenfold return, is a projection from sponsor-reported inputs rather than a measured comparison [2]. A 2020 systematic map of digital recruitment tools found the evidence base thin: most published evaluations are observational [7]. A sponsor can say remote designs have reached large populations quickly when purpose-built, but no published study measures how much faster a decentralized design enrolls the same protocol than a site-based version would.

Does decentralization widen who enrolls?

About 20% of the US population has neither broadband internet nor a smartphone, and that gap is wider among older, rural, lower-income, and minority groups [5]. A fully remote design that assumes participants already own a device and connection can exclude exactly the people it was meant to include. Set against that, decentralized designs can widen the geographic footprint a trial draws from, reaching participants far from any study site [12], and removing the travel requirement is one of the clearer ways to include populations conventional recruitment misses [13]. A trial can widen geographic reach and still narrow its pool by income or connectivity. A fully remote design is more diverse only if the protocol actively plans for participants who cannot supply their own device or connection.

For a closer look at where representation gaps come from, Refero's coverage of diversity in clinical trials goes into the site-selection and eligibility-criteria findings this page does not repeat.

Does decentralization reduce dropout?

Participants say travel burden drives dropout. In a 2025 survey, 76% ranked home or near-home visits and 67% ranked video visits among the most helpful supports [6]. That demand is well documented, but a measured retention advantage for decentralized designs is not: the 2020 systematic map found few controlled comparisons on the retention side either [7]. For what predicts who drops out across indications, Refero's coverage of patient retention in clinical trials covers evidence this page does not repeat.

The decentralized trial platform and vendor landscape, by category

A sponsor building a decentralized protocol buys from several distinct vendor categories, each affecting recruitment or retention differently.

Nine categories cover most of what sponsors contract for: eConsent platforms, eCOA and ePRO platforms, telehealth and virtual-visit platforms, digital health technology and wearable-data providers, direct-to-participant pharmacy and logistics, mobile and home health nursing networks, local health care provider networks and community sites, DCT orchestration platforms that bundle several categories under one contract, and patient recruitment agencies that run outreach on top of any design.

The FDA guidance holds the investigator responsible for oversight regardless of which vendor performs the task [1]. The Clinical Trials Transformation Initiative maintains a planning resource for sponsors working through these categories [14].

When to add decentralized elements to a recruitment plan

Add a remote element when it removes a barrier the protocol actually has, not because a vendor's case study looked appealing. The decision turns on catchment area versus site count (wide catchment with few sites is the clearest case for remote elements), visit frequency and procedure type (questionnaires move off site; blood draws and imaging stay), investigational product stability, population digital access (roughly one in five US adults has neither broadband nor a smartphone) [5], indication acuity, IRB readiness for remote consent [9, 15], and whether the sponsor can staff investigator oversight of remote tasks [1].

Most sponsors land on a hybrid default: decentralize the activities that cost participants the most time, and keep the procedures a site cannot safely delegate where they already work.

Three numbers to stop repeating

Decentralized trial content recycles figures that do not hold up once the citation chain gets followed. A vendor deck leaning on any of these is worth a second look.

"70% of potential participants live more than two hours from a study site." The citation chain runs through conference materials and white papers rather than a survey with a stated sample. No primary source states this number [16].

"Decentralized trials enroll three times faster." Every version traces to a single-trial case study or to the modeled Tufts CSDD estimate, which projects a financial return rather than measuring enrollment speed [2]. The trials that enrolled fast at scale were built remote from day one; that speed has not been demonstrated for a protocol converting midstream [3, 4].

"30% of participants drop out of clinical trials." No single industry-wide dropout rate exists; published rates vary by condition, design, and how attrition gets defined. Refero's benchmarks coverage on patient recruitment documents this gap.

How to choose a decentralized trial platform or recruitment partner

Four questions, drawn from the failure modes above, cover what most differentiates decentralized trial vendors.

1. Which trial activities will you perform remotely, and who is the named investigator responsible for each one? The FDA guidance assigns oversight to the investigator, not the vendor [1].

2. What happens to a participant who has no smartphone or broadband connection? About one in five US adults falls into that group [5].

3. How does your eConsent process satisfy IRB review of remote consent, and which boards have already approved it? A board that has not seen the workflow will add weeks [9].

4. Which of your published performance figures come from a controlled comparison, and which come from a single-trial case study?

If you would rather not run that evaluation alone, see the criteria Refero publishes. Refero screens healthcare marketing and patient recruitment agencies against five published criteria and introduces up to three that fit your brief. It is free for buyers, and there is no obligation to hire anyone we introduce. Tell us what you need.

Frequently asked questions

What are decentralized clinical trials?

A decentralized clinical trial moves some or all activities away from the research site. The FDA's September 2024 guidance frames it as a set of optional elements, such as telehealth visits, remote consent, and direct shipment of the study drug, added to a standard protocol rather than a separate trial type [1].

What is a hybrid clinical trial?

A hybrid trial keeps procedures needing direct supervision at the site while moving lower-acuity activity off it. Most trials using decentralized elements are hybrid, and the FDA holds both designs to the same investigator oversight standard [1, 8].

What is the FDA's guidance on decentralized clinical trials?

The FDA's Conducting Clinical Trials With Decentralized Elements guidance took final effect in September 2024. It assigns responsibility for remote activities: investigator oversight of every task, limits on what local providers may perform, IRB review of remote consent, and sponsor accountability for shipped investigational product [1].

Do decentralized clinical trials recruit faster?

The largest remote enrollment numbers come from trials built remote from the start, not from a comparison against a site-based version of the same protocol. The modeled financial return is an estimate, not an enrollment-speed measurement [2, 3, 4].

Are decentralized clinical trials more diverse?

Decentralized elements can widen the geography a trial draws from, but they assume connectivity that about 20% of US adults do not have. A fully remote design is more diverse only when the protocol budgets for participants without their own device or connection [5, 12].

Sources

• US Food and Drug Administration. Conducting Clinical Trials With Decentralized Elements: Guidance for Industry, Investigators, and Other Interested Parties. 2024. Link
• DiMasi JA, Smith Z, Oakley-Girvan I, et al. Assessing the Financial Value of Decentralized Clinical Trials. Therapeutic Innovation and Regulatory Science, 2023. Link
• Spertus JA, Birmingham MC, Nassif M, et al. The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial. Nature Medicine, 2022. Link
• Perez MV, Mahaffey KW, Hedlin H, et al. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. New England Journal of Medicine, 2019. Link
• Goodson N, Wicks P, Morgan J, et al. Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion. npj Digital Medicine, 2022. Link
• CISCRP. 2025 Perceptions and Insights Study. Link
• Frampton GK, Shepherd J, Pickett K, et al. Digital tools for the recruitment and retention of participants in randomised controlled trials: a systematic map. Trials, 2020. Link
• NIH Pragmatic Trials Collaboratory. What Is a Decentralized Trial? Rethinking Clinical Trials Living Textbook. Link
• Johns Hopkins Medicine Institutional Review Board. Decentralized Clinical Trials (DCTs) FAQs. Link
• US Food and Drug Administration. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Guidance for Industry. 2023. Link
• Jones WS, Mulder H, Wruck LM, et al. Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease. New England Journal of Medicine, 2021. Link
• Decentralized clinical trials: A comprehensive analysis of trends, technologies, and global challenges. PLOS Digital Health, 2025. Link
• The value of decentralized clinical trials: Inclusion, .... Science, 2024. Link
• Clinical Trials Transformation Initiative. Decentralized Clinical Trials. Link
• Apostolaros M, Babaian D, Corneli A, et al. Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Therapeutic Innovation and Regulatory Science, 2020. Link
• Van Norman GA. Decentralized Clinical Trials: The Future of Medical Product Development? JACC: Basic to Translational Science, 2021. Link