Decentralized clinical trials (DCTs) and hybrid clinical trials are redefining how clinical research is conducted—making studies more accessible, patient-centric, and resilient. These models reduce the dependency on physical sites, use digital tools to manage data and interactions, and expand the reach of research to more diverse populations.
Whether you're a sponsor designing your first hybrid trial or a CRO modernizing study operations, this guide will walk you through the essentials of DCTs: what they are, how they work, and how to implement them successfully.
What Is a Decentralized Clinical Trial (DCT)?
A decentralized clinical trial is a study that uses digital health technologies and remote processes to conduct some or all trial activities outside of traditional investigator sites. Participants can complete assessments, share data, and interact with study staff without traveling to a physical location.
Key characteristics of DCTs include:
- Remote screening and eConsent
- Telehealth visits
- Home health services (e.g., nursing, sample collection)
- Use of wearables and connected devices
- Digital data capture via ePRO, eCOA, and EDC systems
DCTs offer greater geographic diversity, reduced participant burden, and more frequent data collection. However, they also come with challenges around technology access, protocol complexity, and regulatory oversight.
What Is a Hybrid Clinical Trial?
A hybrid clinical trial blends traditional site-based visits with remote and digital elements. For example, a patient may visit a research site for baseline assessments but complete follow-up visits via telehealth or remote monitoring tools.
Hybrid models are ideal for:
- Studies that require some in-person procedures
- Populations that benefit from local support
- Sponsors transitioning from traditional trials to DCTs
They provide flexibility for both study teams and participants while preserving the option of in-person engagement.
Core Technologies Enabling DCTs
Successful decentralized and hybrid trials rely on an integrated digital ecosystem. Core technologies include:
- eConsent and remote enrollment platforms that guide participants through eligibility and consent without requiring site visits
- EDC (Electronic Data Capture) systems for managing structured trial data
- ePRO/eCOA tools for capturing patient-reported and clinician-reported outcomes
- Telehealth platforms to conduct video visits, assessments, and safety monitoring
- Home health and mobile nursing services for at-home sample collection and exams
- Wearables and connected devices that collect real-time health data
- EHR integration to pull in real-world data for screening or outcome tracking
DCT Operational Models
There is no one-size-fits-all approach to DCTs. Operational models can be tailored based on protocol needs, geography, and regulatory constraints.
Fully Remote Model:
- All study interactions (screening, visits, assessments) are conducted digitally
- Ideal for low-risk observational studies or digital therapeutic trials
Hybrid Model:
- Combines remote tools with select in-person visits
- Suitable for interventional studies requiring physical exams or site-based procedures
Site-Led vs. Sponsor-Led DCTs:
- Site-led models empower local investigators with remote tools
- Sponsor-led models centralize digital touchpoints and direct-to-patient logistics
Mapping out the patient journey and identifying remote-eligible activities is key to choosing the right model.
Regulatory and Ethical Considerations
DCTs must still meet the same ethical and regulatory standards as traditional trials. Considerations include:
- FDA guidance on decentralized trials, telehealth, and digital health tools
- IRB review for eConsent workflows and remote procedures
- Data privacy regulations like HIPAA and GDPR
- Informed consent validation (e.g., identity verification, comprehension checks)
Work closely with legal, compliance, and ethics teams when designing and deploying a DCT.
Best Practices for Designing a Decentralized or Hybrid Trial
- Start with a patient-first design: Understand the needs, barriers, and preferences of your target population.
- Map your digital touchpoints: Outline what can and cannot be done remotely.
- Select interoperable technologies: Avoid siloed tools; look for integration-ready platforms.
- Train study staff and participants: Ensure everyone understands how to use remote tools and services.
- Plan for remote monitoring: Equip CRAs with systems to track data quality, queries, and protocol compliance.
Common Pitfalls to Avoid
- Overcomplicating the tech stack with too many disconnected tools
- Neglecting digital literacy by not offering enough participant support
- Skipping pilot phases that validate usability and workflows
- Underestimating site coordination when deploying hybrid protocols
Careful planning, stakeholder involvement, and pilot testing can help mitigate these risks.
Case Examples and Real-World Scenarios
- Phase 2 oncology trial transitioned from traditional to hybrid, reducing dropout rates by offering telehealth for follow-ups.
- Rare disease registry used at-home sample collection and a mobile app to expand enrollment to remote regions.
- Device trial implemented a fully decentralized model using wearables, eConsent, and EDC, cutting data lock time by 40%.
Key Takeaways
- DCTs and hybrid trials are increasing trial access, efficiency, and patient satisfaction
- There is no universal model—flexibility and thoughtful design are essential
- Technology is a tool to enable better research, not a solution by itself
Frequently Asked Questions (FAQs)
1. What’s the difference between decentralized and virtual trials?
"Virtual" often refers to fully digital trials, while "decentralized" includes both digital and in-person components.
2. Can you use sites in a decentralized trial?
Yes—many DCTs use physical sites alongside remote tools.
3. Are DCTs suitable for all trial phases?
They are most common in Phase 2 and 3, but use is expanding into early-phase and post-market studies.
4. How are participants onboarded remotely?
Through eConsent tools, telehealth visits, and digital onboarding workflows that guide them step-by-step.
