Can decentralised clinical trials improve the experience for patients undergoing complex oncology treatments?
In short: Decentralised clinical trials are gaining traction in the UK, promising to reduce participant burden and increase flexibility. However, oncology presents unique hurdles, including intensive safety monitoring and complex interventions. While policy supports this shift, the evidence base remains limited, leaving researchers to navigate regulatory ambiguity and significant operational challenges.
The shift toward decentralised clinical trials (DCTs) represents a strategic priority in UK research policy, aiming to move trial activities away from traditional hospital settings. By integrating remote elements, these trials seek to enhance participant convenience and data collection. Despite this momentum, a recent review of UK academic Clinical Trials Units (CTUs) reveals that adoption in oncology lags behind other medical fields. While 27 CTUs reported high awareness of these methods, their practical application is largely restricted to routine patient follow-up rather than the core trial interventions.
Oncology trials are inherently more demanding than other research areas. The necessity for complex interventions, rigorous safety monitoring, and specific protocol assessments creates distinct barriers to decentralisation. A comprehensive review of 68 studies found that only eight formally evaluated decentralised elements within oncology, and only one of those was UK-based. This single study focused on remote electronic consent during the COVID-19 pandemic, illustrating a significant gap in robust, oncology-specific evidence. Without permanent regulatory guidance, many of the temporary flexibilities introduced during the pandemic remain underutilised.
Beyond the clinical complexities, CTUs face substantial operational hurdles when implementing decentralised models. Governance, infrastructure, and staffing requirements are frequently cited as major challenges. Furthermore, there is a lack of data regarding the acceptability of these approaches among people living with cancer. As researchers push for wider implementation, the consensus is that clearer regulatory frameworks and more thorough evaluations—incorporating direct patient perspectives—are essential to ensure that decentralised oncology trials are both safe and effective.
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Sources
- Summary by Intellect · source: Decentralised Oncology Trials in the UK: Evidence, Regulation and Academic Clinical Trials Units' Perspectives.
- Also: Harriet Walter
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