Decentralized Clinical Trials: The New Standard in Clinical Research
It takes 12 years on average for a new drug to gain market approval from the preclinical stage and costs varying from $1-2.8 billion. Traditional clinical trials have been hampered by systemic challenges, from patient recruitment and retention to the geographic and socioeconomic barriers that limit participation.
Against this backdrop, Decentralized Clinical Trials (DCTs) have emerged as a transformative model. By leveraging digital health technologies, telemedicine, and remote monitoring, DCTs bring the research directly to the patient. Instead of requiring participants to fit their lives around a rigid protocol, this model adapts trial procedures to the patient’s own environment. Today, DCTs are no longer an experiment—they are fast becoming the standard for the future of clinical research.
What Are Decentralized Clinical Trials?
At their core, DCTs are clinical trials designed to reduce or eliminate the need for participants to visit centralized research sites. Instead, trial procedures, data collection, and monitoring are conducted remotely or locally, using a combination of technology and mobile healthcare support.
Key elements of DCTs include:
- Telemedicine & eVisits: Virtual consultations and study visits via secure video platforms.
- Electronic Consent (eConsent): Remote onboarding of participants.
- ePRO/eCOA: Digital patient-reported outcomes and clinical outcome assessments.
- Wearables & Sensors: Continuous data collection on vitals, mobility, and disease-specific endpoints.
- Direct-to-Patient Drug Supply: Investigational product shipped to patient homes under controlled conditions.
- Home Health Visits: Local nurses and healthcare providers conducting tests, specimen collection, or administration.
Types of DCT Models
- Virtual/Remote Trials: Fully off-site, with recruitment, consent, and monitoring handled digitally.
- Hybrid Trials: A blend of decentralized methods and traditional site visits, allowing complex procedures to be conducted on-site while routine data collection happens remotely.
Rise of DCT : From Crisis Catalyst to Industry Standard
The urgency of decentralization was brought into sharp focus during the COVID-19 pandemic, when lockdowns made site visits nearly impossible. Between January and May 2020, remote trial interactions surged from just 9% to 57%. By 2021, 85% of sponsors had integrated remote methods into at least one trial.
Patients also embraced the shift. An Accenture survey across oncology, cardiology, and immunology found that 90% of patients rated virtual care as good or better than pre-pandemic, and 60% wanted technology to remain part of future care.
At the same time, cost and recruitment pressures continue to mount. Industry estimates suggest DCTs can reduce trial costs by 10–25%, and recruitment timelines can shorten significantly thanks to expanded reach and lower patient burden.
The momentum is clear: Up to 70% of all clinical trials are expected to include at least one decentralized component in the near future.
The Value of DCTs for Every Stakeholder
For Patients
- Convenience: DCTs reduce travel burdens and offer flexible scheduling through at-home participation.
- Access: The model opens doors for individuals across geographies, including those in underserved communities or with rare diseases.
- Retention: A patient-centric approach reduces dropouts and increases compliance.
For Sponsors & CROs
- Faster Recruitment: A wider geographic and demographic reach accelerates enrollment.
- Cost Savings: Reduced site visits, lower overhead fees, and fewer travel reimbursements lead to significant savings.
- Data Depth: Wearables and apps generate continuous, real-world data streams that complement traditional clinical endpoints.
For Regulators
- Patient-Centricity: The DCT model aligns with FDA and EMA initiatives to embed the patient voice in trial design.
- Richer Evidence: Combining real-world and clinical data provides more holistic insights into a therapy’s safety and efficacy.
- Efficiency: More frequent and reliable data points can reduce ambiguity in regulatory submissions.
Real-World Case Studies: DCTs in Action
Infant Formula Study
DCTs are highly effective for reaching pediatric and other hard-to-access populations.
Because it is notoriously difficult to recruit infants for clinical trials, this population is ideal for a decentralized approach. In a fully decentralized study of a new infant formula, caregivers digitally enrolled 215 infants, logged observations via ePRO diaries, and uploaded stool images for remote grading by GI physicians.
COVID-19 Phase 2 Trial
Hybrid models provide a crucial balance of remote convenience and hands-on clinical oversight.
Symptomatic patients in a trial for a COVID-19 treatment were monitored at home using a 6-lead ECG, a pulse oximeter, and a thermometer. Data was streamed automatically, while home healthcare providers conducted key tests and validated the device data.
Urogynecology Study (Stress Urinary Incontinence)
Assumed technology barriers among elderly populations are often overstated.
In the first-ever fully virtual urogynecology study, women used a smart intravaginal device to monitor pelvic floor muscle contractions during at-home Kegel exercises for stress urinary incontinence. Counter to initial concerns, women aged 65 and older showed higher completion rates than younger participants.
Menopause Trial – Real-Time AE Detection
DCTs enable powerful, real-time pharmacovigilance.
A participant in a virtual menopause trial reported a “slight headache” in her daily e-diary. The information was immediately available to the principal investigator, who flagged it, recommended a lower dosage, and enabled the early detection of a worsening COPD condition.
Across all cases, key themes emerge: expanded recruitment, higher compliance, proactive safety, and hybrid flexibility.
Nine Principles for Successful DCT Design
To ensure a smooth transition into decentralization, sponsors should adhere to these best practices:
- Validate Digital Endpoints – Ensure ePROs, eCOAs, and wearable-derived endpoints are equivalent to validated paper or clinical measures.
- Technology Should Support, Not Replace, Clinicians – Patient questions and safety oversight remain essential.
- Engage Regulators Early – Proactive engagement avoids compliance surprises and builds confidence.
- Build Risk Mitigation Plans – Anticipate device failures, drug shipping challenges, and dropout contingencies.
- Adapt Participant Training – Use multimedia, on-demand training modules to empower patients and caregivers.
- Prioritize Participant Optionality – Offer choices between site visits, televisits, or home nursing based on preference.
- Recruit Inclusively – Provide devices, stipends, or internet access to avoid excluding disadvantaged populations.
- Simplify Protocols – Eliminate unnecessary endpoints or procedures that burden participants.
- Encourage Post-Trial Engagement – Maintain communication for registries, real-world data, and long-term safety follow-up.
These principles ensure trials are both patient-first and regulator-ready.
Artificial Intelligence the Engine of Modern DCTs
Artificial Intelligence (AI) is rapidly becoming a cornerstone of decentralized trial execution:
- Recruitment & Matching: AI parses eligibility criteria, extracts computable phenotypes from EHRs, and identifies target patients at scale.
- Population Enrichment: Phenomapping helps pinpoint subpopulations more likely to benefit, increasing trial efficiency.
- Monitoring & Retention: AI-powered apps provide medication reminders and personalize patient coaching.
- Adverse Event Detection: Natural language processing (NLP) enables real-time triage of patient diaries, telehealth transcripts, and safety reports.
- Post-Trial Safety: Machine learning algorithms sift through RWE, EHRs, and literature for faster signal detection.
AI in DCTs enhances speed, accuracy, and safety, while reducing manual burdens on coordinators.
Challenges to Address
Despite momentum, DCT adoption faces hurdles:
- Protocol Consistency: Ensuring standardized execution across digital and physical touchpoints.
- Data Reliability: Managing high-volume, high-velocity wearable data while preserving integrity.
- Infrastructure Gaps: Limited connectivity in certain geographies.
- Regulatory Variability: Differences in state/national rules on telemedicine and data sharing.
- Digital Divide: Risk of excluding populations without access to technology.
These challenges can be mitigated through unified platforms, patient support services, and inclusive design.
The Road Ahead: From Necessity to Norm
The pandemic accelerated DCT adoption out of necessity. Now, sponsors, CROs, regulators, and patients have seen its advantages—and there is no going back.
- Hybrid trials will dominate in the near term, balancing complex procedures with decentralized convenience.
- Virtual-first trials will grow in indications like dermatology, neurology, and pediatrics where endpoints can be digitally captured.
- AI integration will further streamline recruitment, monitoring, and pharmacovigilance.
- Unified platforms will replace fragmented technology ecosystems, reducing cost and complexity.
Ultimately, DCTs are not just a new way to conduct trials—they are the foundation of a patient-first, data-rich, and globally inclusive future of clinical research.
For sponsors and CROs, the mandate is clear: embrace innovation, partner closely with regulators, and put the patient at the center. Those who do will not only accelerate development timelines but also redefine the standard of care in clinical research.
