New guidelines have been published this week in the Nature Medicine, The BMJ and The Lancet Digital Health which will improve the quality of clinical trial studies using AI systems.

These new reporting guidelines (SPIRIT-AI and CONSORT-AI) are a result of research undertaken by a partnership including the University of Birmingham, University Hospitals Birmingham NHS Foundation Trust, Wellcome Trust Institutional Strategic Support Fund: Digital Health Pilot Grant, Research England, Health Data Research UK and The Alan Turing Institute.

The guidelines will ensure that clinical trials are reported transparently and in turn, will enable medical professionals, funders and regulators to assess the quality and potential risks of the algorithm and ensure that patient benefit is paramount.

Professor Alastair Denniston, Director of the INSIGHT Health Data Research Hub and Consultant Ophthalmologist, commented: “Patients could benefit hugely from the use of AI in medical settings, but before we introduce these technologies into everyday practice we need to know that they have been robustly evaluated and proven to be effective and safe. Our previous work showed just how big a problem this can be and that we needed a way to cut through the hype surrounding AI in healthcare.

These new reporting guidelines – SPIRIT-AI and CONSORT-AI – provide a solution to the ‘hype’ problem. They provide a clear, transparent framework to support the design and reporting of AI trials that will help to improve quality and transparency. These extended guidelines will help to reduce wasted effort and deliver effective AI-led medical interventions to patients quicker.”

You can find out more about our work on better, faster and more efficient clinical trials here.

Read the publications