Decentralized clinical trials (DCTs) have reshaped how clinical research is designed and delivered. By using digital tools such as eConsent, ePROs, telehealth visits, and remote monitoring devices, DCTs have allowed studies to be conducted partly – or even fully – outside traditional site settings. This has made research more accessible and far more patient-centric, reducing the burden of travel while enabling trials to reach more diverse populations.
As trials expand across different nations and languages, the success of digital and decentralized models also depends on culturally-accurate patient communication. This includes translated eConsent materials and ePRO questionnaires – both examples of areas where Conversis supports sponsors to ensure global participants can confidently engage with every stage of a virtual study.
This article will bring all of the above together, helping you to understand what exactly DCTs are, their benefits, common challenges, and the technology that has made them possible.
What Exactly Are Decentralized Clinical Trials?
Decentralized clinical trials use digital technologies to conduct participant activities outside a physical site. Instead of requiring all visits to occur in person, DCTs use remote tools, connected devices, and digital communication platforms to improve data collection and patient interaction.
Core Components of DCTs
- eConsent: Digital informed consent forms that allow patients to review, understand, and sign documents remotely.
- ePROs / eCOA: Electronic patient-reported outcomes and clinical outcome assessments completed on smartphones or tablets for real-time symptom and adherence tracking.
- Telehealth Visits: Virtual appointments enabling clinicians to conduct assessments, answer questions, and maintain contact without requiring travel.
- Wearables and Connected Devices: Sensors and home-use medical devices that collect continuous or episodic health data (e.g., heart rate, glucose levels, mobility).
- Remote Monitoring: Centralized oversight of patient data and safety signals through secure digital platforms.
Fully Remote vs Hybrid Trials
- Fully Remote Trials: All participant activities – screening, consent, assessments, and follow-up – take place outside a clinical site, supported entirely by digital platforms and home-based procedures.
- Hybrid Trials: A blend of on-site and remote activities. Participants attend essential in-person visits (e.g., imaging, sample collection) but complete routine or low-risk assessments digitally from home.
What Are the Benefits of Decentralized Clinical Trials Over Traditional Clinical Trials?
DCTs offer practical and scientific advantages that are reshaping how studies are run. These include:
Wider Recruitment & Improved Diversity
By removing geographic and logistical barriers, DCTs let sponsors enroll participants from rural communities and underrepresented regions. This expands access for patients with rare diseases and increases the representativeness of trial populations, which strengthens generalizability and equity in trial outcomes.
Richer, Real-World Data
Continuous data from wearables and BYOD ePROs capture day-to-day patient experiences in natural settings. This longitudinal, high-frequency data can reduce recall bias, improve endpoint fidelity, and reveal treatment effects or safety signals that occasional clinic visits might miss.
Cost & Time Efficiencies
Reducing the number of on-site visits lowers overhead and speeds study timelines. Faster enrollment and improved retention can reduce per-participant costs across recruitment, monitoring, and site management.
What Technology Is Enabling This Digital Shift?
Naturally, more sophisticated technologies have paved the way for successful decentralized clinical trials. Let’s take a look at what these involve:
Digital Twins & AI for Simulation
Digital twins are computerized models that mirror real patient populations. Digital twins are being increasingly combined with AI to simulate trial scenarios before a study begins. By running computer simultations of experiments, sponsors can:
- Model virtual cohorts to predict patient recruitment rates, dropout, and likely endpoint behavior.
- Test protocol variations (visit schedules, inclusion criteria) to identify designs with higher power or faster timelines.
- Support adaptive designs by forecasting interim outcomes and refining stopping rules or allocation algorithms.
- Reduce operational risk by revealing likely bottlenecks or safety signal patterns before exposing real patients.
Think of this as running many low-cost trial “what-if” studies. The main goal is to create a better study design, ensure fewer surprises, and make more efficient decision-making – not to replace human oversight.
Platforms & Integrations
Modern DCTs rely on integrated technology stacks that bring together multiple data streams and operational functions:
- Orchestration platforms unify eConsent, ePRO/eCOA collection, telehealth visits, device data ingestion, and direct-to-patient (DTP) shipping workflows so activities run smoothly for participants and sites.
- Data capture and management pipelines feed device and patient data into electronic data capture (EDC) and clinical data management systems (CDMS) for cleaning, monitoring, and analysis in near real time.
- Interoperability & standards are practical necessities: using recognized standards (for example, CDISC for clinical data) reduces integration issues, enables smoother regulatory submissions, and helps maintain auditability.
- Security & privacy layers encrypt data in transit and at rest and provide audit trails to meet regulatory and GDPR/HIPAA expectations.
- APIs let sponsors plug in third-party services without rebuilding core systems, enabling modular, scalable implementations.
Common DCT Challenges (& How to Overcome Them)
There are several common challenges when running decentralized clinical trials. Fortunately, for each problem, there’s a practical solution:
Access to the Internet or Devices
Lack of broadband or suitable devices is one of the clearest barriers to DCT participation.
Mitigation strategies include providing study devices or data stipends, supporting BYOD with minimum-spec guidance, designing offline-capable apps that sync when connected, and partnering with community clinics or pharmacies as local access points.
Translation & Localization of Digital Trial Materials
eConsent forms, ePROs, app interfaces, and patient instructions must be accurately translated and culturally adapted to preserve meaning and regulatory validity.
Conversis specializes in clinical trial translations and can localize eConsent, ePRO items, patient-facing app text, and instructional materials to support global enrollment while protecting data integrity.
Regulatory & Data-Privacy Concerns
Remote data flows and cross-border patient recruitment raise questions about consent, data residency, encryption, and auditability.
To overcome this, adopt privacy-by-design (data minimization, strong encryption, role-based access), document data flows for regulators, and engage regulatory authorities early to confirm acceptable approaches.
Suitability Limitations of Fully Remote Designs
Not every intervention or assessment can be done remotely, such as complex imaging or intensive safety monitoring.
Use hybrid designs that keep only essential, high-risk procedures on site; deploy mobile nursing for in-home specimen collection; or set up regional hubs for specialized testing. Early feasibility work – including plain-language, localized participant materials – helps determine which sites and participants are a good fit.
Conversis’ localization services can support clearer participant guidance and site materials during feasibility planning.
Participant Engagement, Training, & Support
Remote participants need excellent onboarding, clear instructions, and responsive technology support to stay engaged.
Use short multimedia onboarding, multilingual helpdesk support, automated reminders, and regular digital touchpoints. Monitor patient engagement metrics and intervene early for low adherers with targeted support or simplified workflows.
Scale Your Decentralized Study With Confidence
At Conversis, we specialize in clinical trial translations, localization, and patient-facing communications – from eConsent and ePROs to regulatory documents – ensuring materials are both accurate and culturally adapted.
Contact our linguistic specialists today to discuss how we can support your decentralized trial design and improve participant comprehension.
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