{ "id": "eppgs68x8h", "slug": "decentralized-clinical-trial", "title": "Decentralized clinical trial", "updated": "2026-10-15", "topic_path": [ { "id": "life", "label": "Life and health", "api_url": "https://www.edgepedia.org/api/v1/topics/life" }, { "id": "life.health", "label": "Human health and medicine", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health" }, { "id": "life.health.public", "label": "Public health and healthcare", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.public" }, { "id": "life.health.public.clinical-research-trials", "label": "Clinical research and trials", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.public.clinical-research-trials" } ], "geo": [ { "id": "geo.nongeo.t2001.life.health.public", "label": "Non-geographic · 2001 to 2020: Public health and healthcare", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health.public", "path": [ { "id": "geo.nongeo", "label": "Non-geographic", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo" }, { "id": "geo.nongeo.t2001", "label": "Non-geographic · 2001 to 2020", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001" }, { "id": "geo.nongeo.t2001.life", "label": "Life and health", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life" }, { "id": "geo.nongeo.t2001.life.health", "label": "Human health and medicine", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health" }, { "id": "geo.nongeo.t2001.life.health.public", "label": "Public health and healthcare", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health.public" } ] } ], "excerpt": "A decentralized clinical trial is a clinical study in which activities like visits, consent, and data collection happen remotely or locally rather than at a traditional trial site.", "snippet": "A decentralized clinical trial is a clinical study in which activities like visits, consent, and data collection happen remotely or locally rather than at a traditional trial site.", "node": "life.health.public.clinical-research-trials", "markdown": "# Decentralized clinical trial\n\nA decentralized clinical trial (DCT) is a clinical study in which some or all trial-related activities, such as recruitment, informed consent, visits, and data collection, occur at locations other than the investigator's traditional trial site. The FDA defines it as a trial that includes decentralized elements, meaning activities carried out at locations such as telehealth visits, in-home visits, or visits with local health care providers.[1](https://www.fda.gov/media/167696/download) The design spans a spectrum from fully decentralized trials with no on-site visits to hybrid trials that combine remote and on-site elements.[2](https://health.ec.europa.eu/system/files/2023-03/mp_decentralised-elements_clinical-trials_rec_en.pdf) The motivation is access: when Andrea Coravos wrote on the topic in 2018, less than 5% of the US population participated in clinical research and more than 70% of the population lived more than two hours from an academic medical center.[3](https://pmc.ncbi.nlm.nih.gov/articles/PMC8617428/)\n\n| Key fact | Detail |\n|---|---|\n| Definition | Trial activities occur at locations other than traditional trial sites (FDA, US statute, EU guidance)[1](https://www.fda.gov/media/167696/download) • [4](https://rethinkingclinicaltrials.org/chapters/design/decentralized-pragmatic-clinical-trials/what-is-a-decentralized-trial/) |\n| Effect agreement | 51 decentralized vs 86 traditional trials showed no systematic difference in treatment effects (summary ratio of odds ratio 1.01)[5](https://www.bmj.com/content/bmj/391/bmj-2025-084307.full.pdf) |\n| Enrollment speed | DCT elements raised enrollment per site per month from 0.40 to 0.46 (oncology) and from 0.26 to 1.015 (non-oncology)[6](https://www.nature.com/articles/s41598-026-46193-7) |\n| Timeline gains | Enrollment ran 22.3 days shorter and protocol-approval-to-database-lock 102.7 days shorter than planned in 69 DCT-supported trials[7](https://www.appliedclinicaltrialsonline.com/view/replacing-anecdotal-with-empirical-evidence-on-impact-of-dcts) |\n| Drug trials share | Drugs were used in only 1.8% of 4,874 identified DCT cases; 96.8% of those drugs were previously approved and 67.2% were oral[8](https://pmc.ncbi.nlm.nih.gov/articles/PMC10990725/) |\n| Common technologies | Among 28 self-identified DCTs, e-consent was used in 71%, devices for outcome data in 75%, and patient-reported outcomes in 86%[9](https://link.springer.com/article/10.1186/s13063-026-09922-x) |\n\n## How it works\n\nThe design principle is to move trial procedures to the participant rather than the participant to the site. In practice this means telehealth visits replace or supplement on-site visits, mobile nursing services perform procedures at home, and the investigational product may be shipped directly to the participant; ICH E6(R3) expressly allows shipping the product to the participant's location or dispensing it locally, for administration by site staff, the participant, a caregiver, or a healthcare professional.[10](https://www.fda.gov/media/169090/download) Hybrid designs can combine home visits by mobile healthcare providers with site visits, telemedicine, and mobile-technology data capture.[11](https://doi.org/10.1007/s43441-019-00006-4)\n\nSeveral technologies carry the data stream. Electronic informed consent was used in 71% of self-identified DCTs and devices for outcome data collection in 75%; patient-reported outcomes appeared in 86% of trials and served as the primary outcome in 61%.[9](https://link.springer.com/article/10.1186/s13063-026-09922-x) Direct-to-participant drug shipment suits products with good stability profiles; drugs requiring specialized handling, shipping, and storage may not be suited for shipment outside a traditional site.[1](https://www.fda.gov/media/167696/download)\n\n## How it is done\n\nA decentralized trial is planned around which activities move and which stay. The FDA does not consider obtaining informed consent an appropriate activity for a local healthcare provider to perform; investigators may obtain consent electronically or on paper at remote locations.[1](https://www.fda.gov/media/167696/download) The EU recommendation paper sets a gradient: the more vulnerable the population, the less known the product's safety profile, and the more complex the trial, the more necessary a physical meeting for consent; remote consent discussions should occur in real time with audio and video and verified identities.[2](https://health.ec.europa.eu/system/files/2023-03/mp_decentralised-elements_clinical-trials_rec_en.pdf)\n\nVisit decisions are protocol-specific. The protocol should specify which visits are on-site, remote, or the participant's choice, and tests performed independently at home, such as spirometry, may introduce variability that training or video supervision during a telehealth visit can reduce.[1](https://www.fda.gov/media/167696/download) The safety monitoring plan must describe how local healthcare providers report concerning events and how participants report adverse events, and investigators remain responsible for supervising delegated activities.[1](https://www.fda.gov/media/167696/download)\n\nData verification adapts rather than disappears. Monitoring divides into centralized and site monitoring, generally combined; site monitoring may be performed off-site (remotely) depending on its purpose and suitability.[2](https://health.ec.europa.eu/system/files/2023-03/mp_decentralised-elements_clinical-trials_rec_en.pdf) Danish guidance allows remote source data verification of electronic medical records when monitors receive restricted, secure access limited to trial participants' records, but on-site monitoring remains relevant for most trials because site monitoring assesses general protocol and Good Clinical Practice compliance beyond source data verification.[12](https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/decentralised-clinical-trials/~/media/5A96356760ED408CBFA9F85784543B53.ashx)\n\n## Origin\n\nCraig Lipset dates the idea of a decentralized trial to the early 2000s, pointing to a 2003 feasibility study on conducting decentralized trials and a fully decentralized 2005 study of anxiety and insomnia treatments as precursors.[3](https://pmc.ncbi.nlm.nih.gov/articles/PMC8617428/) The REMOTE trial, a web-based trial of [tolterodine](https://www.edgepedia.org/tolterodine) ER 4 mg for overactive bladder by Miguel Orri and colleagues in Contemporary Clinical Trials in 2014, is frequently cited as the first entirely web-based trial conducted under an IND application.[13](https://doi.org/10.1016/j.cct.2014.04.009) • [14](https://journals.plos.org/digitalhealth/article?id=10.1371%2Fjournal.pdig.0001166) Maria Apostolaros and colleagues published the CTTI legal and regulatory recommendations in Therapeutic Innovation & Regulatory Science in 2019.[9](https://link.springer.com/article/10.1186/s13063-026-09922-x) • [11](https://doi.org/10.1007/s43441-019-00006-4)\n\nThe COVID-19 pandemic accelerated adoption: a survey found 76% of pharmaceutical companies, device manufacturers, and contract research organizations adopted decentralized techniques during the early phase of the pandemic.[15](https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.1081150/full) Regulation followed: the Danish Medicines Agency and Swissmedic published guidance in 2021, the EMA issued a recommendation paper in 2022, and the FDA and Clinical Research Malaysia published guidance in 2023.[8](https://pmc.ncbi.nlm.nih.gov/articles/PMC10990725/) The Food and Drug Omnibus Reform Act of 2022, Section 3606, required the FDA to publish guidance advancing decentralized clinical trials; the FDA draft guidance of May 2023 was finalized in September 2024.[16](https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1664648/full) • [1](https://www.fda.gov/media/167696/download) ICH E6(R3), adopted into FDA guidance in 2025, endorses decentralized approaches.[10](https://www.fda.gov/media/169090/download)\n\n## Variants\n\nThe Danish guidance distinguishes fully decentralized trials, with no on-site visits, from hybrid trials combining on-site and remote elements; full decentralization is not feasible when participants cannot be adequately monitored remotely or when procedures such as imaging require on-site evaluation.[12](https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/decentralised-clinical-trials/~/media/5A96356760ED408CBFA9F85784543B53.ashx) Suitability has limits: administration of an investigational product with a high-risk safety profile, early-stage safety data, or complex administration may need in-person investigator supervision at a traditional site, and fully decentralized designs may be appropriate only for products with well-characterized safety profiles that do not require complex preparation or medical assessments.[1](https://www.fda.gov/media/167696/download)\n\n## Applications\n\nAdoption is measurable but concentrated. A [ClinicalTrials.gov](https://www.edgepedia.org/clinicaltrials-gov) analysis identified 4,874 DCT cases with annual increases especially after 2020.[8](https://pmc.ncbi.nlm.nih.gov/articles/PMC10990725/) A systematic review found 33 publications of 28 unique trials explicitly identifying as decentralized, all published since 2021, with median sample size 900 (IQR 192 to 1470); all were single-country studies and 96% came from high-income countries.[9](https://link.springer.com/article/10.1186/s13063-026-09922-x)\n\nNotable examples include the ADAPTABLE study by Abigail Johnston, W. Schuyler Jones, and [Adrian F. Hernandez](https://www.edgepedia.org/adrian-f-hernandez), a fully remote aspirin-dosing trial in which patients consented through an electronic portal, bought their own aspirin, and reported outcomes via a web portal,[4](https://rethinkingclinicaltrials.org/chapters/design/decentralized-pragmatic-clinical-trials/what-is-a-decentralized-trial/) • [17](https://doi.org/10.1007/s11886-016-0749-2) and ACTIV-6 by the ACTIV-6 Study Group, a decentralized outpatient platform trial for repurposed COVID-19 medicines that enrolled patients from all 50 states with 26,000 patients engaging the online portal and all study medications mailed.[4](https://rethinkingclinicaltrials.org/chapters/design/decentralized-pragmatic-clinical-trials/what-is-a-decentralized-trial/) • [18](https://doi.org/10.1017/cts.2023.644)\n\nOn outcomes, a 2025 BMJ meta-epidemiological study compared 51 decentralized with 86 non-decentralized trials across 11 clinical questions and found no systematic difference in treatment effects (summary ratio of odds ratio 1.01), with significance agreeing in 9 of 11 questions (82%).[5](https://www.bmj.com/content/bmj/391/bmj-2025-084307.full.pdf) In the sponsor-level SHASTA analysis, DCT elements were associated with higher enrollment per site per month versus historical benchmarks, 0.46 vs 0.40 for oncology and 1.015 vs 0.26 for non-oncology trials.[6](https://www.nature.com/articles/s41598-026-46193-7) In the PACT consortium dataset of 69 trials, actual enrollment timelines ran on average 22.3 days shorter than planned and protocol-approval-to-database-lock timelines 102.7 days shorter, with faster enrollment correlated with higher proportional use of remotely performed procedures (\\( p < .01 \\)).[7](https://www.appliedclinicaltrialsonline.com/view/replacing-anecdotal-with-empirical-evidence-on-impact-of-dcts)\n\n## Limitations and alternatives\n\nThe digital divide is a primary equity risk. Spanish guidance requires that decentralized elements always be used on a voluntary basis, taking into account the digital divide that may be more present in some specific populations.[19](https://www.aemps.gob.es/medicamentosUsoHumano/docs/2024/Guia-DCT_EN.pdf) Privacy risks extend beyond the trial: data stored on personal devices can be linked to other personal data such as contacts, location, microphone, camera, and purchases.[15](https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.1081150/full) Retention can fail: the REMOTE trial experienced drop-out so significant that confirmation of safety and efficacy of the drug was precluded, although another account states the study was terminated early due to inadequate patient enrollment.[14](https://journals.plos.org/digitalhealth/article?id=10.1371%2Fjournal.pdig.0001166)\n\nDiversity gains are mixed rather than uniform. CTTI lists increased diversity of enrolled populations as a potential advantage,[11](https://doi.org/10.1007/s43441-019-00006-4) but PACT data show Asian representation of 20.9% with DCT components versus a 14.2% benchmark and Indigenous representation of 1.9% versus 0.5%, while local locations were associated with a 38% increase in Black or African descent enrollment and virtual and home visits with much lower percentages of Black enrollees.[7](https://www.appliedclinicaltrialsonline.com/view/replacing-anecdotal-with-empirical-evidence-on-impact-of-dcts) Data completeness also varies by task: for required data collection virtual sites are comparable to brick-and-mortar sites, but for optional, burdensome clinical outcome assessments the physical sites were more likely to generate complete data.[6](https://www.nature.com/articles/s41598-026-46193-7)\n\n## References\n\n1. [Conducting Clinical Trials With Decentralized Elements: Guidance for Industry, Investigators, and Other Interested Parties (FDA, final guidance, September 2024)](https://www.fda.gov/media/167696/download)\n2. [Recommendation Paper on Decentralised Elements in Clinical Trials (EU/EMA-HMA, EudraLex Vol. 10)](https://health.ec.europa.eu/system/files/2023-03/mp_decentralised-elements_clinical-trials_rec_en.pdf)\n3. [Core Concept: In the wake of COVID-19, decentralized clinical trials move to center stage (PNAS)](https://pmc.ncbi.nlm.nih.gov/articles/PMC8617428/)\n4. [What Is a Decentralized Trial? (NIH Collaboratory Rethinking Clinical Trials)](https://rethinkingclinicaltrials.org/chapters/design/decentralized-pragmatic-clinical-trials/what-is-a-decentralized-trial/)\n5. [Agreement of treatment effects in decentralised trials versus traditional trials: meta-epidemiological study (BMJ, 2025)](https://www.bmj.com/content/bmj/391/bmj-2025-084307.full.pdf)\n6. [Measuring the added benefits of decentralized trial elements (SHASTA): impact on enrollment, demographics, and data completeness through a single sponsor (Scientific Reports)](https://www.nature.com/articles/s41598-026-46193-7)\n7. [Replacing Anecdotal With Empirical Evidence On Impact of DCTs (Applied Clinical Trials, Tufts CSDD PACT consortium data)](https://www.appliedclinicaltrialsonline.com/view/replacing-anecdotal-with-empirical-evidence-on-impact-of-dcts)\n8. [The landscape of decentralized clinical trials (DCTs): focusing on the FDA and EMA guidance](https://pmc.ncbi.nlm.nih.gov/articles/PMC10990725/)\n9. [Adoption of 'decentralized' clinical trial terminology: a systematic review of self-identified decentralized clinical trials (Trials, 2026)](https://link.springer.com/article/10.1186/s13063-026-09922-x)\n10. [E6(R3) Good Clinical Practice Guidance for Industry (FDA, September 2025)](https://www.fda.gov/media/169090/download)\n11. [Maria Apostolaros and colleagues (2019). Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Therapeutic Innovation & Regulatory Science.](https://doi.org/10.1007/s43441-019-00006-4)\n12. [The Danish Medicines Agency's Guidance on Digital and Decentralised Clinical Trials](https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/decentralised-clinical-trials/~/media/5A96356760ED408CBFA9F85784543B53.ashx)\n13. [Miguel Orri and colleagues (2014). Web-based trial to evaluate the efficacy and safety of tolterodine ER 4mg in participants with overactive bladder: REMOTE trial. Contemporary Clinical Trials.](https://doi.org/10.1016/j.cct.2014.04.009)\n14. [Running a clinical trial remotely: Lessons learnt from a decentralised multicentre randomised controlled trial evaluating a digital health intervention for Chronic Kidney Disease (SMILE-K) (PLOS Digital Health)](https://journals.plos.org/digitalhealth/article?id=10.1371%2Fjournal.pdig.0001166)\n15. [Decentralized clinical trials (DCTs): A few ethical considerations (Frontiers in Public Health, 2022)](https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.1081150/full)\n16. [The status quo of the development of decentralized clinical trials (Frontiers in Medicine, 2025)](https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1664648/full)\n17. [Abigail Johnston, W. Schuyler Jones, Adrian F. Hernandez (2016). The ADAPTABLE Trial and Aspirin Dosing in Secondary Prevention for Patients with Coronary Artery Disease. Current Cardiology Reports.](https://doi.org/10.1007/s11886-016-0749-2)\n18. [The Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group (2023). ACTIV-6: Operationalizing a decentralized, outpatient randomized platform trial to evaluate efficacy of repurposed medicines for COVID-19. Journal of Clinical and Translational Science.](https://doi.org/10.1017/cts.2023.644)\n19. [Guidelines for undertaking decentralized items in clinical trials (AEMPS, Spain, 2024)](https://www.aemps.gob.es/medicamentosUsoHumano/docs/2024/Guia-DCT_EN.pdf)\n\n---\n*Topic: Encyclopedia › Life and health › Human health and medicine › Public health and healthcare › Clinical research and trials*\n\n*Initially written Sep 29, 2026 · Edited: Oct 15, 2026*\n\n*Copyright 2026 EdgeChat AI, a subsidiary of Biostate AI.*\n\nLicense: Edgepedia Community License 1.0, https://www.edgepedia.org/edgepedia/license\n", "same_as": [], "url": "https://www.edgepedia.org/decentralized-clinical-trial", "markdown_url": "https://www.edgepedia.org/decentralized-clinical-trial.md", "license": { "name": "Edgepedia Community License 1.0", "url": "https://www.edgepedia.org/edgepedia/license", "summary": "Free with credit, commercial use included. AI training is open to everyone. For other uses, organizations over USD 100M in revenue or 100M monthly users license separately.", "spdx": "LicenseRef-Edgepedia-Community-1.0" }, "credit": "\"Decentralized clinical trial\", Edgepedia (EdgeChat), https://www.edgepedia.org/decentralized-clinical-trial. Edgepedia Community License 1.0.", "credit_md": "\"[Decentralized clinical trial](https://www.edgepedia.org/decentralized-clinical-trial)\", Edgepedia (EdgeChat), [https://www.edgepedia.org/decentralized-clinical-trial](https://www.edgepedia.org/decentralized-clinical-trial). [Edgepedia Community License 1.0](https://www.edgepedia.org/edgepedia/license).", "credit_html": "\"Decentralized clinical trial\", Edgepedia (EdgeChat), https://www.edgepedia.org/decentralized-clinical-trial. Edgepedia Community License 1.0.", "speakable": "A decentralized clinical trial is a clinical study in which activities like visits, consent, and data collection happen remotely or locally rather than at a traditional trial site." }