Decentralised Oncology Trials in the UK: Evidence, Regulation and Academic Clinical Trials Units’ Perspectives

Objectives

Decentralised clinical trials (DCTs) are increasingly promoted in UK research policy and practice; however, their benefits and implementation challenges in oncology remain unclear. We examined DCT use in oncology through a review of studies evaluating decentralised oncology trial delivery, UK regulatory and policy frameworks and a survey of UK academic Clinical Trials Units (CTUs).

Design

Multimethod study including a structured literature review, policy review and cross-sectional survey of UK Clinical Research Collaboration (UKCRC)-registered CTUs.

Setting

International literature, UK-based regulatory and policy documents and survey data from UKCRC-registered CTUs.

Interventions

None.

Main outcome measures

Literature review: decentralised components evaluated and reported outcomes.

Policy review: opportunities, barriers and gaps in UK regulatory and policy guidance relevant to DCTs.

Survey: CTU awareness, uptake, perceived benefits and challenges related to decentralised trial delivery, comparing oncology and non-oncology settings.

Results

Of 68 studies meeting broader eligibility criteria, only 8 formally evaluated decentralised elements within oncology trials and were included in the primary synthesis. Conducted across five countries, these studies primarily assessed feasibility, recruitment, usability and data completeness. Only one UK oncology study formally evaluated DCT methods, assessing use of remote electronic consent to support recruitment during the COVID-19 pandemic, highlighting limited published UK evaluation. Non-UK studies showed mixed findings, including improvements in trial processes or participant satisfaction in some contexts alongside operational challenges in others.

The UK-based policy review identified strategic support for decentralisation but fragmented regulatory guidance and ambiguity around key decentralisation concepts. Temporary COVID-19-induced flexibilities demonstrated feasibility but have not been fully incorporated into permanent guidance.

Survey responses were received from 27 CTUs (54% response rate). Awareness of decentralised approaches was high; however, use of these was lower in oncology than in non-oncology trials. Decentralisation was most commonly applied to patient follow-up. CTUs reported reduced participant burden and increased flexibility, but also challenges relating to governance, contracting, infrastructure, staffing and data management.

Conclusions

Decentralised approaches in UK oncology trials are gaining momentum but remain unevenly adopted, alongside a limited oncology-specific evidence base, regulatory ambiguity and operational challenges. Oncology presents distinct challenges that may limit decentralisation of trials compared with other disease areas, including complex interventions, intensive safety monitoring requirements and protocol-specific assessments. Evidence on patient/public involvement and acceptability of decentralised approaches among people with cancer remains limited. Clearer guidance and more robust evaluation, incorporating patient perspectives, are needed to support wider implementation in the UK and may also be relevant internationally.