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The clinical research landscape is undergoing a profound transformation. Traditional site-centric trials, long considered the gold standard, are increasingly complemented—or replaced—by decentralized clinical trials (DCTs) and hybrid monitoring models. These approaches leverage digital technologies, telemedicine, and risk-based oversight to improve patient access, enhance data quality, and optimize operational efficiency.
A decentralized clinical trial is a study where some or all trial-related activities occur away from traditional research sites, often in participants’ homes or local healthcare facilities. Enabled by telemedicine, eConsent, wearable devices, and remote data capture, DCTs aim to “bring the trial to the patient” rather than requiring patients to travel to hospitals and clinics.
The key features of these DCTs include:
- Remote recruitment and consent via secure digital platforms.
- Direct-to-patient drug delivery and home health visits.
- Continuous data collection through wearables and mobile apps.
- Electronic Patient-Reported Outcomes (ePRO) and virtual visits.
DCTs have many benefits such as improving accessibility and diversity, allowing the inclusion of rural and underserved populations, and reducing patient burden as there would be fewer site visits, and lower travel costs. In addition, they will provide real-time monitoring through connected devices, and faster recruitment and retention as patient-centric design increases engagement.
But there are also some challenges:
- Technology barriers: Limited digital literacy or internet access.
- Regulatory complexity: Variability across regions (FDA vs. EMA guidelines). Different states have varying laws and rules for shipping investigational drugs.
- Data integrity and security: Ensuring compliance with HIPAA/GDPR, as well as ensuring reliable, secure data when multiple systems and vendors are involved.
- Safety concerns: How do you monitor adverse events remotely?
- Patient engagement: Maintaining adherence in remote settings.
Hybrid Clinical Trials: The Best of Both Worlds
While fully virtual trials offer flexibility, they may not suit all therapeutic areas or procedures. Hybrid trials combine remote elements (telehealth, ePRO, wearables) with in-person visits for complex assessments or interventions. This model has become the preferred approach, balancing innovation with regulatory compliance.
Hybrid models are gaining traction due to operational practicality (maintains site oversight for high-risk procedures), regulatory clarity (EMA, FDA, and ICH E6(R3) now recognize hybrid strategies), patient-centricity, and technology integration (unified platforms for EDC, eSource, and remote monitoring).
Monitoring has evolved from 100% on-site Source Data Verification (SDV) to risk-based hybrid oversight, blending remote and targeted site visits. This new strategy combines the following core components:
- Remote Source Data Review (SDR) via secure portals.
- Centralized monitoring for anomaly detection.
- On-site visits focused on critical data and investigational product accountability.
A hybrid monitoring strategy will provide several benefits, such as cost efficiency (reduced travel and resource burden), improved data quality (continuous, real-time dashboards detect risks early), broader patient inclusion (supports global, multi-site trials) and regulatory alignment ICH E6 (R3) emphasizes proportionate, risk-based monitoring.
Regulatory Considerations of Hybrid Monitoring:
Recent FDA guidance (2024) and EMA frameworks stress:
- Participant safety and data integrity as core principles: Develop clear remote monitoring protocols and train staff.
- Validation of digital systems and audit trails for remote data.
- Risk-based monitoring plans to mitigate variability in decentralized settings.
- Data privacy compliance (HIPAA, GDPR) and secure remote access protocols.
- Engage early: Involve regulators, patients, and vendors from the planning stage.
- Clarify roles: Define responsibilities for investigators and mobile healthcare providers.
- Protect privacy: Implement strong data security measures.
As a conclusion, we can confirm that decentralized and hybrid clinical trial models are shaping the future of clinical research. By leveraging digital health technologies, risk-based monitoring, and patient-centric design, sponsors can achieve greater efficiency, inclusivity, and compliance. However, success depends on robust technological infrastructure, clear regulatory strategies, and proactive patient engagement and buy in from Investigators and research sites.
Authors:
Suzanne Mathias, Senior Director Clinical Monitoring
Angel Perez, Director Clinical Operations