Decentralised Clinical Trials: A Smarter, More Inclusive Future

Decentralised Clinical Trials (1)

Imagine being asked to join a clinical trial, but the nearest site is two hours away and you care for an elderly parent while working full-time. The burden of travel alone could be enough to say no. That’s the challenge decentralised clinical trials (DCTs) aim to solve.

Traditionally, clinical research has centred around brick-and-mortar sites. Participants travel for every check-up, lab draw and questionnaire. But this system excludes many who cannot accommodate these demands. However, thanks to digital tools and evolving trial models, that’s changing.

DCTs bring the research to the participant. Whether through video calls, wearable devices, or local sample collection, they reduce the need for travel and improve access. The shift accelerated during the pandemic, but its staying power comes from something deeper: a smarter, more inclusive way to run clinical research.

What is a Decentralised Clinical Trial (DCT)?

A DCT reimagines how participants engage with research. Instead of requiring travel to a central site, technology and community-based services support participation wherever people are.

This might include video consultations for consent, delivering medication directly to homes or capturing continuous health data through smartwatches and apps. Some DCTs are fully remote, while others follow a hybrid model that blends on-site oversight with digital convenience. The goal remains the same: preserve scientific integrity while making trials more accessible and adaptable.

Why Shift from Site-Based to Decentralised Clinical Trial Models?

In a traditional trial, everything revolves around the site. Participants commute to appointments, report symptoms in person and rely on printed diaries or manual follow-ups. Access is limited by geography and time.

DCTs flip the model. Participants check in virtually, receive reminders through apps and track their health in real time. If an in-person visit is needed, it happens locally or through home visits. By putting people at the centre, these trials reduce burden, improve engagement, and allow a broader range of individuals to participate.

Patient-Centric Research: Putting People First

At its heart, decentralisation is about respecting how people live. It makes participation possible for more people, especially those historically left out of research. That inclusivity and patient-centric focus leads to more representative data and better insights.

Participants are not just data sources. They are people with lives, routines and obligations. When we design trials to fit into their world rather than the other way around, we create studies that are more human and more effective.

Streamlining DCT Operations Without Sacrificing Scientific Rigour

DCTs offer operational efficiency. Fewer physical sites, faster enrolment and continuous data collection help accelerate timelines and reduce costs. But success still hinges on careful planning, robust training and clear communication.

Engagement tools like app reminders and virtual check-ins help participants stay involved. Real-time data supports faster decision-making and reduces gaps in reporting. Done right, DCTs are faster, cheaper and still meet the highest scientific and regulatory standards.

Benefits of Decentralised Clinical Trials – and Execution Challenges

Decentralisation unlocks a handful of key advantages. These include the following:

Improved Access & Diversity
Research shows that around 70% of participants live more than two hours from a site. Removing travel as a barrier helps include caregivers, full-time workers, and people in rural areas.

Richer Data
Real-time tracking through wearables or mobile apps gives researchers a continuous stream of insight, not just snapshots from visits. This enhances safety monitoring and captures how treatments affect everyday life.

Better Recruitment & Retention
Flexible trial design reduces dropout and accelerates enrolment. When people can participate without disrupting their routines, they are more likely to stay involved.

Yet, beneath these benefits lies a common issue: data fragmentation.

The Hidden Hurdle: Consolidation Decentralised Trial Data

Many DCTs rely on disconnected tools. A wearable device might collect sleep data, a home nurse might submit lab results, and an app might capture self-reported symptoms. But if each system uses different formats, units or coding standards, integrating that data becomes a messy and error-prone process.

Regulatory expectations around traceability and audit readiness only raise the stakes. Without consistent data models and shared dictionaries, it's hard to ensure quality or compliance. Despite global efforts from groups like CDISC and FHIR, full interoperability remains a work in progress.

Key Data Standards Questions for Scaling DCTs

Are we investing enough in shared data standards before scaling DCTs?
Who is responsible for harmonising inconsistent wearable data?
Can sponsors and vendors agree on universal lab and device formats?
How do we ensure data integrity when study activities happen anywhere, anytime?

From Innovation Point Solutions to Unified DCT Infrastructure

Hybrid trial models are becoming mainstream because they balance participant convenience with oversight. While tools such as AI and blockchain show promise for trend detection and traceability, the real need is for tools that consolidate data, not just add more layers.

A key example is Medidata Clinical Data Studio. It offers a unified platform that ingests data from diverse sources (Rave EDC, sensors, labs and wearables) applying AI-powered reconciliation and quality monitoring. This means issue detection can happen a lot faster than before.

Instead of stitching together multiple point solutions, Clinical Data Studio provides a single environment where formats are standardised and anomalies flagged automatically, giving data managers and monitors a clear, holistic view.

This is the type of foundation DCTs need, a unified tool that brings order to complexity. Without it, we risk decentralisation becoming a series of disconnected trials, convenient in theory but chaotic in execution.

Sponsor Checklist: Implementing Decentralised Clinical Trials Successfully

Start with Feasibility
Not all studies are suited to full decentralisation. Consider the target populations's digital readiness and what elements truly need physical oversight.

Choose the Right Partners
Prioritise vendors with a proven track record in DCTs. Seek platforms that integrate well with your systems and offer user-friendly support.

Plan for Change
Transitioning teams and participants to digital models requires hands-on training, pilot runs, and ongoing support. Don't underestimate the human side of implementation.

Scale Smart
Begin with a pilot. Collect feedback, refine workflows, and scale up only once the foundation is solid.

Regulatory Alignment for Decentralised Clinical Trials

As DCTs evolve, sponsors must align with evolving frameworks from the FDA, EMA, IRBS, and data protection laws (GDPR, HIPAA) to ensure participant safety, data integrity, and ethics.

U.S. Food and Drug Administration (FDA)

In the FDA's 2023 draft guidance for DCTs, sponsors should endeavour to match decentralised elements to trial complexity, for example, opting for fully remote models for well-understood products and hybrid designs when specialist assessments are needed. They should also utilise electronic consent with IRB oversight, identity verification, and transparent risk disclosure, ensuring to define clear adverse event reporting channels (whether remote or in-person) all while designating a site for FDA inspections.

European Medicines Agency (EMA)

EMA guidance on DCTs aligns with the FDA's principles but adds European-specific considerations, advising sponsors to evaluate and standardise remote procedures and train staff to reduce errors and protect data integrity. This also includes ensuring remote tasks are feasible for participants and caregiver to partake in without compromising care, and maintaining transparency on risks, rights, and protections throughout the entirety of the trial.

Institutional Review Boards (IRBs)

IRBs play a key role in overseeing the ethical aspects of DCTs. This is achieved by approving eConsent and telehealth processes that uphold ethical standards, continuously monitoring adverse events to enforce corrective actions and ensure ongoing participant protection, as well as confirming that participants receive clear information and are presented with opportunities to ask questions.

Data Protection & Privacy Laws

Compliance with data protection regulations is of utmost importance in DCTs. For example, In the EU, the GDPR mandates guidelines on data collection, processing, and storage. Sponsors must obtain explicit consent from participants for data processing and ensure data is stored securely.

In the US, on the other hand, HIPAA sets standards for the protection of health information. Here, sponsors must implement safeguards to protect participants' health data and ensure it is used solely for the purposes outlined in the informed consent.

By streamlining oversight across these regulatory bodies and laws, DCTs can be integrated responsibly and maintain the scientific and ethical rigour as traditional trials.

The Future of Decentralised Clinical Trials

Decentralised trials are not just a trend, but rather the beginning of a long-term shift in how research is designed and delivered. The acceleration and implementation of hybrid models will continue to redefine the future of drug development, combining digital convenience with human oversight.

Emerging technologies like AI, wearables, and integrated platforms will drive further innovation. But to truly succeed, the focus must be on shared systems, aligned expectations and participant-centric design.

Conclusion

DCTs are not just about moving trials online. They are about moving research closer to real life. When we remove barriers and design for people, not just protocols, we create a smarter, more inclusive future for clinical trials.

Quanticate's clinical data management team combines deep expertise in wearable health data integration, CDISC-aligned data models, and AI-powered issue detection to streamline your DCT workflows. By focusing on standardised metadata, continuous quality monitoring, and seamless aggregation of remote and on-site data, we transform fragmented steams into a unified source. If you're ready to elevate your decentralised trial data integrity, accelerate decision-making, and simplify regulatory submissions, submit an RFI today.

FAQs

Should there be a central location or physical site in a DCT?

Not always. Some DCTs are fully remote, while others follow a hybrid model, combining remote and on-site elements. For complex procedures like imaging or lab tests, a central site may still be needed. The key is flexibility. Design the study around what’s best for both data quality and patient experience.

What are the different types of remote clinical data capture?

Remote clinical data can be captured through several methods, each offering a practical way to gather information outside of a traditional trial site. Wearables track real-time metrics like heart rate, activity, and sleep. Mobile apps support eDiaries, questionnaires, and reminders to keep participants engaged. Telemedicine enables virtual assessments and consultations, while home health visits allow nurses to collect samples and check vitals in person. Electronic Data Capture (EDC) systems securely manage structured trial data. Together, these tools provide a fuller, real-world picture of how treatments work in everyday life.

What's the difference between a decentralised clinical trial and a virtual clinical trial?

The terms decentralised clinical trial (DCT) and virtual clinical trial are closely related, but they are not the same. A virtual clinical trial is usually conducted entirely remotely, with no need for participants to visit a physical site at any point. In contrast, a decentralised clinical trial refers to any study model that moves some trial activities away from a central research site. This could include a mix of digital tools, home health visits, and local clinics, alongside occasional in-person site visits. In short, while all virtual trials are a form of decentralised trial, not all decentralised trials are fully virtual.

References & further reading

Regulatory Guidance

Data Standards & Interoperability