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09-01-2021
The growing availability of advanced artificial intelligence (AI) tools has the potential to reshape how clinical trials are delivered and managed, offering significant potential benefits while also raising complex ethical and governance considerations.
In response, the UK Registered Clinical Trials Units (CTU) Network has established a dedicated group focused on developing and sharing best practice on the use of AI in trial conduct and management. The group draws on individuals with a range of backgrounds from across the Network, bringing a variety of perspectives to this work.
The aim is to ensure that innovation supports high-quality research, enhances impact, and reduces unnecessary waste, whilst ensuring trial integrity
As part of this effort, the Network has issued an interim position statement outlining key principles for the responsible use of AI. This includes a strong emphasis on maintaining ethical standards and regulatory compliance while the field continues to evolve.
“Pending the development of a formal UKCRC CTU Network AI framework and guidance, CTUs using AI technologies should ensure that any use of AI is proportionate, transparent, appropriately governed, and aligned with existing institutional policies, regulatory requirements, and professional standards.
The use of AI must protect the rights, safety, dignity, and confidentiality of research participants and individuals, including compliance with applicable data protection legislation (including UK GDPR), information governance requirements, and ethical obligations.
CTUs should ensure that the use of AI does not compromise scientific integrity, data quality, accountability, or oversight responsibilities. Appropriate consideration should also be given to intellectual property, copyright, confidentiality, contractual obligations, and the ownership and use of data and outputs generated through AI systems.
Any use of AI within trial conduct or CTU operations should be subject to appropriate human oversight, risk assessment, validation, and documentation processes, and should follow local institutional guidance and governance arrangements.
This statement is intended as an interim position while the UKCRC CTU AI Thematic Group develops guidance on the safe and responsible use of AI in clinical trial settings.”
The Network’s work reflects a broader recognition across the research community that while AI offers incredible opportunities, its integration must be carefully managed. Balancing innovation with robust governance will be critical to ensuring that AI strengthens, rather than undermines, the integrity and trustworthiness of clinical research.
Find out more about the Network’s Thematic Groups here.
To keep up to date with the work of the Network follow us on LinkedIn or Bluesky.
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