FDA
Center for Clinical Trial Innovation
CDER’s C3TI is a hub for innovative approaches to clinical trials and drug development, connecting demonstration projects with broader learning.
Read more : Center for Clinical Trial Innovation ↗Clinical trials should come to you.
Decentralized approaches move selected study activities closer to participants. Explore published research on their potential benefits and limitations. These findings describe other studies and settings; they are not measured TrialPilot outcomes.
Why it matters
Better for patients. Better for science.
Travel, rigid schedules, and geographic exclusion can make research harder to join. Published studies explore how different designs affect access, enrollment, retention, cost, and safety—and where uncertainty remains.
Trials that look like the real world
The 69-trial PACT comparison reported American Indian or Alaska Native participation of 1.9% with decentralized elements versus 0.5% in traditional trials. Asian participation was 20.9% versus 14.2%. The report found no significant difference in Black participation; inclusion still requires deliberate support.
Simpler paths to enrollment
Oxford launched RECOVERY in nine days through a streamlined protocol and an existing hospital research network. It illustrates pragmatic trial design at speed, rather than a fully remote trial or a timeline every study can expect.
Participation that lasts
In Heartline, 93% of participants were actively engaged with the app at least weekly after one year, and 86% after two years. The study used a deliberately designed engagement program; those results are specific to its participants and methods.
Data from real life, not just clinic visits
Wearables and phones can capture observations between appointments. FDA guidance addresses selecting and using digital health technologies for remote data collection, including whether a measurement is suitable for its intended use.
$41 million in modeled value
DiMasi and colleagues estimated an additional $41 million in expected net present value per Phase III investigational drug, with roughly 13-fold return on the added DCT cost. This is a financial model driven largely by cycle-time assumptions, not observed savings for every trial.
Safety needs a response plan
Remote reports and wearable measurements can extend visibility between visits. The wearable review and virtual-vigilance commentary examine the practical limits: appropriate measures, reliable data, clinical review, and clear follow-up remain essential.
A framework for decentralized elements
FDA guidance, the EMA recommendation paper, and ICH’s evolving good clinical practice materials address activities beyond traditional sites. They guide protocol design and oversight; they do not endorse a particular platform or replace study-specific obligations.
An expanding, mostly hybrid landscape
Jiang and colleagues reviewed 1,097 drug trials with decentralized attributes starting in 2014–2023. Of that selected sample, 97.6% used hybrid designs. Published reviews explore both the opportunities and the gaps in evidence about performance.
The numbers, in context
Different studies. Specific findings.
Keep the population, methods, and assumptions with each result. These studies do not measure TrialPilot’s performance.
Studies to learn from
Oxford. Yale. NIH. Apple. Different paths to better research.
These examples span decentralized and pragmatic trials. Each offers useful design lessons; none establishes that every activity should happen remotely or that one approach always performs better.
University of Oxford / NEJM
RECOVERY Trial
Launched in nine days · Pragmatic hospital trial
A streamlined protocol and existing hospital network enabled rapid setup and recruitment. RECOVERY’s dexamethasone comparison helped answer an urgent treatment question. Its hospital-based design is an example of pragmatic research, not a fully remote trial.
Read more →
Johnson & Johnson + Apple
Heartline Study
93% weekly app engagement after one year · Ages 65+
An app-based engagement program supported remote participation by older adults. The engagement analysis reports 86% weekly participation after two years, while electronic questionnaire completion was 82% at one year. Those measures describe different kinds of participation.
Read more →
Duke / PCORnet / NEJM
ADAPTABLE Trial
15,076 participants · EHR-supported pragmatic research
ADAPTABLE compared aspirin dosing using electronic health records, electronic consent, and follow-up through a patient portal or call center. Its 40 centers and one health plan show how digital participation can work alongside an established care network.
Read more →
NIH / Duke
ACTIV-6
Remote follow-up · Mailed study medication
This outpatient platform evaluated repurposed medications for COVID-19 using decentralized enrollment, medication delivery, and remote outcome collection. The operational report describes both the delivery model and the work needed to run it.
Read more →
NCI / SWOG
Pragmatica-Lung
838 participants · 13% Black enrollment
A simplified, pragmatic lung-cancer trial reduced data-collection burden and emphasized representation. SWOG reported that 15% of participants lived in rural locations. It illustrates protocol and outreach choices within clinical care, not an entirely at-home trial.
Read more →
Yale School of Medicine
Yale PAX LC Trial
100 Long COVID participants · Nationwide design
Yale brought consent, mailed medication, electronic diaries, and sample collection closer to participants. Its account includes both home visits and nearby laboratory visits—a concrete example of making research more accessible for people living with Long COVID.
Read more →
Policy and industry momentum
The framework is taking shape.
Regulatory guidance, research collaborations, and investment shape how trials evolve. Each tells a different part of the story.
U.S. framework
PDUFA VII and trial modernization
The 2023–2027 program includes digital-health commitments. FDA also identifies statutory requirements to develop guidance on decentralized trials and digital health technologies.
Read more : PDUFA VII and trial modernization ↗Across jurisdictions
FDA, EMA, and Health Canada
The U.S. final guidance and European recommendation paper address decentralized elements. Health Canada’s draft consultation closed in February 2026; its consultation summary is available.
Read more : FDA, EMA, and Health Canada ↗Published in Science
Inclusion, accessibility, and innovation
Jean-Louis and Seixas review the value of decentralized trials. The paper belongs alongside implementation studies and critical reviews when considering where the model fits.
Read more : Inclusion, accessibility, and innovation ↗Industry forecast
$18.8B projected by 2030
BCC Research estimates an $8.8 billion market in 2024 and projects $18.8 billion by 2030. This is a commercial market forecast, separate from evidence of clinical or operational benefit.
Read more : $18.8B projected by 2030 ↗500+ organizations
CTTI’s cross-sector community
The Clinical Trials Transformation Initiative brings researchers, industry, patient advocates, and regulators together to improve trial practices and develop recommendations.
Read more : CTTI’s cross-sector community ↗A closer look · 2025 review
Decentralization is a design choice.
A review of drug trials with decentralized attributes found that almost all used a hybrid approach. Its findings challenge the idea that moving activities remotely will automatically transform trial performance.
Read Jiang et al., npj Digital Medicine ↗- Drug trials analyzed
- 1,097
- Used hybrid designs
- 97.6%
The review’s selected sample of trials starting in 2014–2023. These figures describe that dataset, not all clinical trials or TrialPilot results.
Recommendations · 2024
Access needs support.
Moving an activity online can change who can take part. The equity recommendations examine how decentralized approaches can support inclusion, and how study design must address barriers to participation.
Ask who might still be left out, and what support they need.
Read the source ↗: Access needs support.Final guidance · 2023
Remote data needs a purpose.
FDA guidance addresses using digital health technologies to collect data remotely in clinical investigations. The technology, measurement, and intended use belong in the study design together.
Choose measures for the research question, then qualify the collection workflow.
Read the source ↗: Remote data needs a purpose.Final guidance · 2024
Location changes. Oversight remains.
FDA guidance describes decentralized elements such as telehealth, home visits, and visits with local health care providers. These are activities to plan within a clinical trial, with appropriate responsibilities and oversight.
Decide which tasks can move, who owns them, and how concerns reach the team.
Read the source ↗: Location changes. Oversight remains.From evidence to study design
Three questions worth asking.
Our practical takeaways for planning a study. The right answers depend on your participants, protocol, and operating team.
01
What are we asking of people?
Consider travel, task frequency, device access, and what happens when someone needs to pause. Test the participant journey before recruitment.
Rehearse in test mode ↗02
What will the data support?
Define the outcome, inspect missingness, and read estimates alongside uncertainty. A trend should not become a stronger claim than the study can support.
Understand Trial Signal ↗03
Who will follow through?
Make safety review, routine support, and data queries part of the team’s operating plan. A collected record still needs the right review and response.
Explore safety operations ↗The Evidence
Follow the evidence. Keep the context.
The original reading library is here, alongside newer research. Reviews, trial reports, regulatory documents, and industry reports serve different purposes. Read each source for its methods and limits.
- 1. Jean-Louis G, Seixas AA “The value of decentralized clinical trials: Inclusion, accessibility, and innovation.” Science, 385(6711):eadq4994 (2024). View source →
- 2. Aiyegbusi OL, et al. “Recommendations to promote equity, diversity and inclusion in decentralized clinical trials.” Nature Medicine, 30(11):3075-3084 (2024). View source →
- 3. Hernandez AF, Lindsell CJ “Ensuring Virtual Vigilance in Decentralized Clinical Trials.” JAMA, 333(2):119-120 (2025). View source →
- 4. Inan OT, Tenaerts P, Prindiville SA, et al. “Digitizing clinical trials.” npj Digital Medicine, 3:101 (2020). View source →
- 5. Vayena E, Blasimme A, Sugarman J “Decentralised clinical trials: ethical opportunities and challenges.” The Lancet Digital Health, 5(6):e390-e394 (2023). View source →
- 6. National Academies of Sciences, Engineering, and Medicine “Virtual Clinical Trials: Challenges and Opportunities.” The National Academies Press (2019). View source →
- 7. DiMasi JA, Smith Z, Oakley-Girvan I, et al. “Assessing the Financial Value of Decentralized Clinical Trials.” Therapeutic Innovation & Regulatory Science, 57(2):209-219 (2022). View source →
- 8. RECOVERY Collaborative Group “Dexamethasone in Hospitalized Patients with Covid-19.” New England Journal of Medicine, 384:693-704 (2021). View source →
- 9. Jones WS, Mulder H, Wruck LM, et al. “Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease (ADAPTABLE).” New England Journal of Medicine, 384:1981-1990 (2021). View source →
- 10. U.S. Food & Drug Administration “Conducting Clinical Trials With Decentralized Elements (Final Guidance).” Federal Register, September 2024 (2024). View source →
- 11. European Medicines Agency “Recommendation Paper on Decentralised Elements in Clinical Trials.” EMA/HMA Guideline, December 2022 (2022). View source →
- 12. ICH “E6(R3) Good Clinical Practice Annex 2 (final).” ICH harmonised guideline, Adopted June 3, 2026 (2026). View source →
- 13. U.S. Food & Drug Administration “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” FDA Guidance, December 2023 (2023). View source →
- 14. Getz KA, et al. “Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups.” Therapeutic Innovation & Regulatory Science (2022). View source →
- 15. Rogers A, et al. (Trials@Home Consortium) “A systematic review of methods used to conduct decentralised clinical trials.” British Journal of Clinical Pharmacology, 88(6):2843-2862 (2022). View source →
- 16. Jiang Y, et al. “Understanding the gap between expectations and reality in decentralized clinical trials.” npj Digital Medicine, 8:408 (2025). View source →
- 17. Miyata BL, Tafuto B, Jose N “Methods and perceptions of success for patient recruitment in decentralized clinical studies.” Journal of Clinical and Translational Science, 7(1):e232 (2023). View source →
- 18. Zuidgeest MGP, et al. (Trials@Home RADIAL) “Bringing Trial Activities to Participants—The Trials@Home RADIAL Proof-of-Concept Trial Investigating Decentralization of Trials.” Clinical Pharmacology & Therapeutics, 118:1037-1045 (2025). View source →
- 19. Shen R, et al. “Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study.” Journal of the American Heart Association, 12(13):e027899 (2023). View source →
- 20. Medable, reporting Tufts CSDD/PACT data “DCT Components Linked to Improvements in Clinical Trial Access Among Underrepresented Communities (corrected release).” Business Wire · sponsor report (2025). View source →
- 21. Baudry G, et al. “Decentralized clinical trials in cardiovascular disease: A primer for clinical trialists.” Nature Cardiovascular Research (2026). View source →
- 22. Heartline investigators “The Heartline Experience: Achieving Long-Term Participant Engagement in Digital Health Technology Trials.” JACC: Advances (2025). View source →