Clinical trials should come to you.
70% of patients live too far from a trial site to participate. Decentralized trials change that โ bringing research directly to people's homes, phones, and wearables. Faster answers. More inclusive science. Better outcomes for everyone.
Why It Works
Better for patients. Better for science.
When you remove the barriers โ travel, rigid schedules, geographic exclusion โ everything improves. Enrollment, retention, diversity, and even cost. The evidence is clear.
Trials that look like the real world
Native American enrollment jumped 4x. Asian participation nearly doubled. When you meet patients where they are, your trial finally reflects the population it's meant to help.
Enrollment in days, not years
The RECOVERY trial was set up in 9 days and enrolled 48,500 patients โ 23x more than a comparable U.S. trial. Fewer forms, simpler protocols, and no geographic limits mean you fill trials faster.
Patients who actually stick around
93% of patients 65+ stayed engaged for a full year in the Heartline Study โ from their couch. Traditional trials lose 20-30% of participants. When the trial fits into life, people stay.
Data from real life, not just clinic visits
Wearables and phones capture what's actually happening between appointments. Heart rate at 3am. Steps on a bad day. The FDA now has dedicated guidance for exactly this kind of data.
$41 million in value. Per program.
A Tufts study of 59 real DCT contracts found 5-13x ROI. Every day you shave off a clinical trial is worth $40,000. Decentralized trials cut Phase III timelines by up to a year.
Safety signals in hours, not weeks
Why wait for the next clinic visit to find out something's wrong? Continuous wearable monitoring catches adverse events as they happen โ so you can act immediately.
The FDA, EMA, and Congress agree
The FDA created a permanent center for trial innovation. Congress mandated DCT frameworks through 2027. The EMA and ICH followed. This isn't a pilot program โ it's the new playbook.
The industry has already moved
87% of sponsors are running or planning decentralized trials โ up from 28% before COVID. Over 1,370 DCTs on ClinicalTrials.gov. This train has left the station.
The Numbers
This isn't theory. It's already happening.
Real trials. Real patients. Published in the world's top medical journals.
Who's Already Doing It
Oxford. Yale. NIH. Apple. They didn't wait.
The world's top institutions are running decentralized trials right now โ and the results speak for themselves.
RECOVERY Trial
Set up in 9 days. 45% fewer forms. Enrolled 23x more patients than a comparable U.S. trial. The treatment they found โ dexamethasone โ saved an estimated 650,000 lives in six months.
Heartline Study
Elderly patients. No site visits. Apple Watch on their wrist. And 93% were still actively participating a full year later. That's what happens when the trial fits into life.
ADAPTABLE Trial
15,000 heart patients. No clinic visits. Run entirely through electronic health records and online platforms. The New England Journal of Medicine published the results.
ACTIV-6
Study drugs mailed to your door. Check-ins from your phone. 7,500+ patients tested multiple treatments without setting foot in a clinic. Results published in JAMA.
Pragmatica-Lung
Simplified the protocol. Opened 1,600 sites. Black enrollment jumped from 8% to 13%. Proof that better design creates better representation โ not just better technology.
Yale PAX LC Trial
The first fully decentralized Phase 2 Long COVID trial. Consent, drug delivery, monitoring โ everything happened in patients' homes. This is personal to us.
The Tipping Point
When the FDA, Congress, and the EU all agree โ pay attention.
Every major regulatory body on the planet is now actively pushing for decentralized trials. The question isn't if โ it's how fast.
Center for Clinical Trial Innovation
Not a task force. Not a working group. A permanent center dedicated to making trials faster, smarter, and more accessible.
Learn more โPDUFA VII Mandate
This wasn't a suggestion. Congress wrote decentralized trial modernization into law โ with dedicated funding through 2027.
Learn more โFDA + EMA + Health Canada
Three continents. Three regulatory bodies. All saying the same thing: decentralized trials are the path forward.
Learn more โDCTs Are a Paradigm Shift
When Science publishes a review calling your approach a paradigm shift, that's not hype โ it's consensus.
Read the paper โ$18.8B by 2030
From $8.8B today to $18.8B by 2030. The money is following the science โ and the science says decentralize.
Learn more โCTTI Consortium
500+ organizations โ pharma, regulators, patient groups โ all building the infrastructure together. This is an entire ecosystem, not a solo bet.
Learn more โThe Evidence
We don't make claims we can't back up.
Every number on this page links to a peer-reviewed study, regulatory document, or institutional report. Dig in.
- 1. Jean-Louis G, Seixas AA โThe value of decentralized clinical trials: Inclusion, accessibility, and innovation.โ Science, 385(6711):eadq4994 (2024). View source โ
- 2. Aiyegbusi OL, et al. โRecommendations to promote equity, diversity and inclusion in decentralized clinical trials.โ Nature Medicine, 30(11):3075-3084 (2024). View source โ
- 3. Hernandez AF, Lindsell CJ โEnsuring Virtual Vigilance in Decentralized Clinical Trials.โ JAMA, 333(2):119-120 (2025). View source โ
- 4. Inan OT, Tenaerts P, Prindiville SA, et al. โDigitizing clinical trials.โ npj Digital Medicine, 3:101 (2020). View source โ
- 5. Vayena E, Blasimme A, Sugarman J โDecentralised clinical trials: ethical opportunities and challenges.โ The Lancet Digital Health, 5(6):e390-e394 (2023). View source โ
- 6. National Academies of Sciences, Engineering, and Medicine โVirtual Clinical Trials: Challenges and Opportunities.โ The National Academies Press (2019). View source โ
- 7. DiMasi JA, Smith Z, Oakley-Girvan I, et al. โAssessing the Financial Value of Decentralized Clinical Trials.โ Therapeutic Innovation & Regulatory Science, 57(2):209-219 (2022). View source โ
- 8. RECOVERY Collaborative Group โDexamethasone in Hospitalized Patients with Covid-19.โ New England Journal of Medicine, 384:693-704 (2021). View source โ
- 9. Jones WS, Mulder H, Wruck LM, et al. โComparative Effectiveness of Aspirin Dosing in Cardiovascular Disease (ADAPTABLE).โ New England Journal of Medicine, 384:1981-1990 (2021). View source โ
- 10. U.S. Food & Drug Administration โConducting Clinical Trials With Decentralized Elements (Final Guidance).โ Federal Register, September 2024 (2024). View source โ
- 11. European Medicines Agency โRecommendation Paper on Decentralised Elements in Clinical Trials.โ EMA/HMA Guideline, December 2022 (2022). View source โ
- 12. ICH โE6(R3) Good Clinical Practice Annex 2.โ Federal Register, December 2024 (2024). View source โ
- 13. U.S. Food & Drug Administration โDigital Health Technologies for Remote Data Acquisition in Clinical Investigations.โ FDA Guidance, December 2023 (2023). View source โ
- 14. Getz KA, et al. โAssessing the impact of travel burden on clinical trial retention.โ Therapeutic Innovation & Regulatory Science (2022). View source โ
- 15. Rogers A, et al. (Trials@Home Consortium) โA systematic review of methods used to conduct decentralised clinical trials.โ British Journal of Clinical Pharmacology, 88(6):2843-2862 (2022). View source โ
- 16. Jiang L, et al. โDecentralized clinical trials: a large-scale analysis.โ npj Digital Medicine, 8:408 (2025). View source โ
- 17. Miyata J, et al. โSystematic review of decentralized clinical trial recruitment and retention.โ Journal of Clinical and Translational Science, 7(1):e232 (2023). View source โ
- 18. Zuidgeest MGP, et al. (Trials@Home RADIAL) โConventional, hybrid, and remote arms in a Phase IV trial.โ Clinical Pharmacology & Therapeutics, 118:1070-1079 (2025). View source โ
- 19. Shen E, et al. โInternet vs non-internet enrollment in the ADAPTABLE trial.โ Journal of the American Heart Association, 12(13):e027899 (2023). View source โ
- 20. Tufts CSDD/PACT Consortium โDecentralized approaches improve diversity in patient populations.โ Applied Clinical Trials / Business Wire (2025). View source โ
