Recommendations for decentralised clinical trial approaches

Recommendations for

decentralised clinical

trial approaches

Six years of multistakeholder

scientific research on

opportunities and challenges...

Development of a set of

recommendations for

implementation of DCT

approaches in clinical trials...

Covering methodological,

regulatory, ethical, operational

and social aspects.

Based on six years of multistakeholder scientific research on opportunities and challenges of decentralised clinical trials (DCTs), the Trials@Home consortium has developed a set of main recommendations covering the methodological, regulatory, ethical, operational and social aspects of DCTs. By nature, these main recommendations are high level, and we encourage users to go to the different content pages for more practical, detailed recommendations.

Main recommendations

Involve patient representatives from the intended study population, as well as research staff and other stakeholders early in the design phase of a trial to determine which trial activities could benefit from a decentralised approach. Keep in mind the research question that the trial aims to answer, and the burden of activities for participants and research staff. Consider that these may change if an activity is decentralised. For example, taking a finger prick blood sample at home is a different burden than going to a lab for a blood draw.

Make a thorough and clear assessment of what is expected from participants in a trial with decentralised elements. These expectations should cover activities to perform, data to collect, digital literacy skills and time spent. Translate this to ensure clear communication with future participants so that they understand what is being asked of them and to ensure fair reimbursement beyond visits and travel reimbursement, especially when they do not need to travel to a site (as often). Our research found that patients prefer DCTs, but at the same time, any added burden or challenges with implementation can negatively impact their experience.

Evaluate a site’s previous DCT experience and capacity to identify any training needs, support or gaps to be addressed prior to implementation, as well as tailored, just-in-time training particularly for novel digital tools and centralised support infrastructures (e.g., help desks and oversight teams during trial conduct). Customisation of regional or national clinical trial agreement templates to accommodate decentralised activities could benefit contracting timelines. Fair site compensation for decentralised efforts should be implemented during contracting.

Designing and executing DCTs which include technologies requires a strategic, system-level approach that prioritises early technology selection, modular integration, and rigorous end-to-end testing. Incorporate practical measures such as structured bring your own device (BYOD) validation, real-world pilot phases, fallback workflows, and dedicated cross-vendor support systems (e.g., help desk). Clear governance processes, including scalable change management and continuous user feedback loops, are essential to maintain study compliance and ensure a resilient DCT setup. Future trials should embed these principles from the outset to reduce disruption and improve scalability.

Enable participant-centred communication ecosystems; because participants are expected to perform more tasks independently at home in DCTs, it is essential to provide additional support. In addition to providing clear and accessible information for participants, researchers should implement participant-friendly communication platforms that support real-time dialogue, asynchronous messaging, and tailored guidance. By offering centralised support to participants, some of the burden on site staff can be reduced, allowing them to focus on their core responsibilities. Prioritising responsive, empathetic, and technology-enabled support can empower participants to carry out trial activities confidently and effectively, enhancing engagement, trust and data quality in DCTs.

Assess any new operational and logistical processes that are needed prior to implementation so that the proper risk-mitigation strategies can be planned, which will enable all parties to quickly deal with hurdles in these processes. These include selecting multiple decentralised sites in one country to mitigate risks of under-recruitment and under-performance and providing multiple reliable options for biological sample collection to improve data completeness. Optimisation of material management and logistics is recommended by implementing just-in-time deliveries to participants’ homes to minimise storage requirements, clearly define importation/exportation responsibilities, and conduct comprehensive end-to-end dry runs to identify logistical vulnerabilities before trial initiation.

Ensure additional specificity around roles and responsibilities because data collection, biological sample collection, and other procedures may be performed through non-traditional routes and involve participants and third-party vendors as the actors more often. Sites need to have access to all data required to maintain oversight and roles and responsibilities. Communication channels also need to be clearly defined before start of the trial.

Implement comprehensive data protection strategies that include early risk assessments, clear vendor responsibilities, secure data flows, and adherence to relevant regulations (e.g., GDPR). DCTs in general include an increased use of digital tools, remote data collection, and third-party technologies compared to site-based trials. This requires enhanced attention to data privacy and security. Special care must be taken when using participant-owned devices and cloud-based systems to ensure confidentiality, integrity, and auditability across the trial lifecycle.

In-depth recommendations per theme

Explore our in-depth recommendations for decentralising specific trial activities, divided into themes.

Activities & Operations

Impact & KPIs

Patient Considerations & Involvement

Assessment & Approval

Oversight & Clinical Management

Technology & Support

About Trials@Home

The Trials@Home consortium explores the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These so-called Decentralised Clinical Trials (DCTs) make use of new, digital innovations and enable participants to visit a clinical trial centre less frequently, if at all.

What is Trials@Home?

What is Trials@Home?

The Trials@Home consortium explored the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These Decentralised Clinical Trials (DCTs) make use of digital and operational innovations, enabling participants to…

What are clinical trials?

What are clinical trials?

Clinical research is the ‘backbone’ of progress in healthcare. Behind every modern medical treatment are people who took part in clinical trials to find out if the medicine was safe and if it worked.

What are DCTs?

What are DCTs?

Clinical trials are essential to prove the safety and efficacy of new medicines. They remain challenging to deliver due to low participation rates. Decentralised Clinical Trial approaches (DCTs) hold the potential to address some of these challenges.

What is RADIAL?

What is RADIAL?

The RADIAL (Remote And Decentralized Innovative Approach to cLinical trials) trial is a pan-European phase IV proof-of-concept trial designed to evaluate the feasibility, acceptability, and quality of decentralised clinical trial (DCT) approaches compared to conventional site-based models.