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The choice of clinical trial model influences study feasibility, participant experience, and the quality of the data collected.
Multicenter trial, decentralized trial, or hybrid trial: each format addresses different constraints. The right choice depends on the protocol, the planned procedures, and the level of supervision required.
Understanding the differences between these models helps build a study that is better suited to participants, investigator sites, and scientific objectives.
The Multicenter Trial: One Common Protocol Across Multiple Sites
A multicenter trial relies on several investigator sites applying a common protocol. These may include hospitals, clinics, research centers, or networks of specialized practices.
This model is particularly suited to studies requiring:
- a large number of participants
- geographic or demographic diversity
- strong clinical supervision
- technical or hospital-based examinations
- standardized procedures across centers
- recruitment capacity distributed across several sites
Multicenter trials are often used for large-scale studies, rare diseases, pivotal trials, or protocols requiring specific medical expertise.
The main challenge remains coordination: harmonizing practices, training teams, managing access rights, tracking missing data, and maintaining a consistent level of quality across sites.
A multicenter trial does not guarantee perfect standardization by itself. This standardization depends on the quality of the protocol, site training, monitoring procedures, consistency checks, and the data collection tools used.
The Decentralized Trial: Integrating Remote Elements into the Protocol
A decentralized trial, or DCT for Decentralized Clinical Trial, integrates elements performed outside the investigator site. These may include home visits, telemedicine, ePRO questionnaires, eConsent, connected devices, local sampling, or remote data collection.
In most protocols, decentralization applies to certain visits, certain assessments, or certain data flows, not the entire study.
These practices are now better regulated. In September 2024, the FDA finalized its guidance on clinical trials with decentralized elements, covering drugs, biological products, and medical devices. In Europe, a recommendation paper on decentralized elements in clinical trials was published in December 2022. ICH E6(R3), adopted in January 2025, reinforces the risk-based approach, quality by design, stakeholder responsibilities, and the appropriate use of technology in clinical trials.
This model can facilitate access to the study for participants, especially when:
- patients live far from investigator sites
- visits are frequent
- follow-up lasts several months
- expected data relate to symptoms, quality of life, or treatment follow-up
- the study population has mobility constraints
- the protocol can be executed without systematic on-site presence
Decentralized trials can also facilitate data collection in the participant’s daily environment. This is useful to better understand symptom evolution, patient experience, or certain behaviors between two visits.
In PMCF studies for medical devices, certain elements can be performed remotely, including questionnaire collection, device use follow-up, or real-world data collection.
Remote data collection must remain controlled. Data collected off-site are not inherently more reliable. They can introduce new risks: variability in measurement conditions, difficulties using digital tools, connectivity issues, selection bias, or insufficient participant support.
The more remote elements a protocol includes, the more it must specify:
- who performs each activity
- who supervises the collected data
- how participants are trained
- how incidents are reported
- how data are timestamped
- how the investigator maintains oversight
- how deviations are documented
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A protocol that integrates decentralized elements must therefore address methodology, organization, supervision, and compliance from the design stage.
The Hybrid Trial: Combining On-Site Visits and Remote Data Collection
A hybrid trial combines on-site visits and decentralized elements. It allows the level of decentralization to be adjusted according to procedures, risks, and expected data.
Some visits must remain on-site, for example:
- imaging
- biopsies
- specialized examinations
- administration of treatment at the center
- complex medical evaluation
- procedures requiring specific equipment
Other elements can be performed remotely, such as:
- ePRO questionnaires
- symptom follow-up
- electronic consent according to the applicable framework
- visit reminders
- teleconsultations
- simple data collection
- follow-up between visits
The hybrid model makes it possible to design a more flexible participant journey without removing the investigator site’s central role. It can improve the participant experience while keeping critical procedures within a controlled clinical environment.
The critical point remains orchestration: responsibilities, visit schedule, data flows, integration into the EDC, and investigator supervision.
BYOD or Provisioned Devices: A Key Choice for Remote Trials
Decentralized and hybrid trials often rely on digital tools used by participants. The choice between BYOD and provisioned devices influences logistics, standardization, and participant experience.
BYOD, or Bring Your Own Device, allows participants to use their own smartphone, computer, or tablet. This approach reduces logistics, simplifies deployment, and avoids providing equipment to each participant.
Provisioned devices consist of giving the participant a dedicated device for the study. This approach can be useful when the protocol requires a standardized technical environment, when measurements must be strictly controlled, or when the target population does not always have access to compatible equipment.
The choice depends on several criteria:
- type of data collected
- level of standardization required
- participant profile
- follow-up duration
- countries involved
- regulatory constraints
- logistics budget
- need for technical support
BYOD is well suited to ePRO questionnaires and simple follow-up. Provisioned devices remain better suited to complex measurements, specific connected devices, or protocols requiring strong technical standardization.
How to Choose the Right Model for Your Protocol?
The choice of model must start from the protocol, not from the technology. The key challenge is to align the study design with scientific objectives, operational constraints, and risk level.
Several criteria should guide the decision.
Nature of the Data Collected
Technical examinations, complex medical procedures, or measurements requiring a controlled environment tend to point toward a site-based or multicenter model. Symptoms, quality of life data, or patient-reported outcomes are more suitable for remote collection via ePRO.
Risk Level for the Participant
The higher the risk, the more structured clinical supervision must be. Treatment administration, invasive procedures, or close monitoring often require a stronger on-site presence.
Visit Frequency
When visits are frequent, the hybrid model can reduce some travel while maintaining critical visits on-site.
Target Population
A fragile population, participants living far from centers, or patients with a chronic disease may benefit from remote follow-up, provided that the tools remain simple and support is adapted.
Geographic Dispersion
For geographically dispersed participants or rare diseases, a multicenter or hybrid model can expand recruitment without multiplying travel constraints.
Local Regulatory Requirements
Telemedicine, eConsent, home delivery, or remote data collection practices are not accepted in the same way everywhere. The model must be validated according to the countries involved.
Data Quality and Traceability
The chosen model must ensure complete, timestamped, auditable, and consistent data across sites. It must also make it possible to track missing data, corrections, queries, and user access.
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