Decentralised clinical trials could make research more accessible, inclusive and take into consideration the participants’ needs. However, successful decentralisation requires more than introducing digital technologies or replacing site visits with remote appointments.

A recent report from the Academy of Medical Sciences, the Association of the British Pharmaceutical Industry and the NIHR Research Delivery Network examines how decentralised trial activities could be adopted more effectively across the UK.

Based on a multidisciplinary workshop which involved approximately 60 representatives from healthcare, industry, academia, government, regulatory bodies and patient communities, the report identifies the opportunities, challenges and actions required to deliver more clinical trials closer to participants.

What Is a Decentralised Clinical Trial and Its Benefits

In a decentralised clinical trial, some or all study activities occur away from the main investigator site. These activities may be delivered in participants’ homes or through primary-care practices, pharmacies and other community facilities.

Decentralised approaches can reduce the time, cost and travel associated with trial participation. They may improve access for people living far from research centres, individuals with limited mobility and those managing work, childcare or caring responsibilities. By reducing geographical and practical barriers, they may also support recruitment, retention and participation among underserved populations.

However, decentralisation is not appropriate for every activity or participant. Fully decentralised medicinal-product trials remain uncommon, particularly where specialist procedures, close safety monitoring or controlled product storage are required. For most studies, a flexible hybrid model combining remote, community-based and conventional site activities is likely to be more appropriate. Participants should be offered meaningful choices wherever clinically and operationally feasible.

Monitoring Decentralised Trial Activities and Challenges

The report presents findings from a 2026 NIHR RDN survey involving 293 respondents. Adoption varied considerably across different trial activities.

Remote communication, pre-screening and quality-assurance activities were relatively common. Respondents also favoured established methods, such as remotely collected patient-reported outcomes and the use of existing healthcare data.

More complex activities were less widely adopted. Remote delivery of investigational products or interventions remained rare, while newer technologies such as home-based sensors and dedicated applications were used less frequently.

The survey identified several barriers to wider implementation:

1. Limited digital infrastructure and system interoperability

2. Uncertainty regarding regulatory expectations

3. Complex contracting, costing and logistical arrangements

4. Insufficient workforce capacity and training

5. Concerns about participants’ ability to use remote technologies

6. Limited awareness of available decentralised methods

The potential benefits of decentralisation also require stronger evidence. Sponsors and research teams need reliable data showing whether specific approaches improve recruitment, retention, participant diversity, data quality, operational efficiency and cost-effectiveness.

Remote delivery may also create new participation barriers. Digital platforms can disadvantage people with limited internet access, unsuitable devices or low digital confidence. Moving activities away from research sites may inadvertently increase participant responsibilities or reduce valuable contact with clinical teams.

Suggestions and Actions Recommended

The workshop produced a structured set of recommendations across three areas:

1. Early Engagement in Trial Design

a)Engage participants and healthcare staff early to identify suitable decentralised activities and reflect participant needs in trial design.

b)Develop clearer, internationally coordinated regulatory guidance to reduce uncertainty and support sponsor confidence.

c)Embed evaluation frameworks and pilot studies within trials to strengthen the evidence base for different decentralised models.

2. Awareness and Knowledge-Sharing

a)Raise awareness among the public and research community, particularly underserved groups, through patient networks, community organisations and research forums.

b)Create shared resources containing evidence, case studies, example protocols, templates and risk assessments.

c)Convene multinational stakeholders to identify implementation challenges early and avoid duplicating the development of remote technologies.

3. Systems and Delivery

a)Define the workforce skills, training, responsibilities and accountability required for decentralised delivery.

b)Update contracting and costing models for hybrid trials and provide sponsors with a clear route for assessing feasibility before protocols are finalised.

c)Improve software interoperability, streamline platform access and reduce the burden created by multiple sponsor-specific systems.

d)Integrate primary, secondary, community and neighbourhood health services, including commercial research delivery centres, into decentralised research pathways.

What This Means in Practice

The UK has the infrastructure, health data assets and supportive policy environment needed to become a global leader in decentralised clinical trial delivery. Realising this potential, however, will require clearer regulatory guidance, a suitably trained workforce, shared implementation resources and commercial models that enable sponsors and research sites to adopt decentralised approaches with confidence.

The report does not propose replacing conventional clinical research with fully decentralised trials. Instead, it advocates a flexible, participant-centred model in which individual trial activities are assessed according to clinical risk, operational feasibility and participant needs.

For sponsors, the immediate priority is to engage research delivery networks early in protocol development, while decentralised elements can still be incorporated effectively. Research sites should strengthen their digital capabilities and capacity to deliver activities within community settings. Regulators and industry bodies should also provide practical, UK-specific guidance covering the full trial-delivery pathway.

Decentralised approaches will not be appropriate for every study or participant. Nevertheless, routinely assessing whether selected activities could be delivered remotely or within the community would help make clinical research more accessible, inclusive and responsive to the populations it aims to serve.

Source: Innovative Clinical Research: Delivering Trials In The Community

Author: Wai Theng Lee, Clinical Research Partnerships Manager