The global scoping review looked at this early phase of testing and revealed huge variations in the way the trials are being conducted and the measures used to assess the effectiveness of the tools.

“This lack of guidance around silent trials is concerning as AI models can be unpredictable and difficult to use in real-world settings if they haven’t been tested thoroughly,” said corresponding author Lana Tikhomirov, a PhD candidate from Adelaide University’s Australian Institute for Machine Learning.

“Some of the trials in our review focused on AI metrics that weren’t clinically useful, while others looked at the bare minimum with no details on how the model performed in a clinical setting.

“If these AI tools are rolled out without comprehensive testing and things go wrong, it could expose both patients and clinicians to harmful advice.”

Silent trials are when AI models are tested in their intended setting for use, but the results don’t influence patient care as they aren’t given to the clinical team at the time of treatment.

Currently there are no formal guidelines on how to conduct these trials, which researchers say are critical to ensure an AI tool will be useful and beneficial in a local setting.

“Silent trials are a low-risk way to test technology without compromising patient outcomes,” said co-author Associate Professor Melissa McCradden, who is the Deputy Director of Adelaide University’s Australian Institute for Machine Learning, AI Director at the Women’s and Children’s Health Network and Hospital Research Foundation Fellow in Paediatric AI Ethics.

“We know that many AI models fail when they’re introduced into real-world settings and an AI tool that works in one hospital may not work in another.

“Conducting comprehensive silent trials that adhere to a clear set of international guidelines is critical if we want to successfully take AI tools from bench to bedside.”

The scoping review has been published in Nature Health and is part of a larger study looking at silent phase evaluations for healthcare AI.

Project CANAIRI – Collaboration for Translational Artificial Intelligence Trials – is focusing on developing guidance for silent trials to ensure health settings in which AI is intended to be used are ready and able to do so in a beneficial way.

“Ultimately, we would like to see silent trials become a mandatory part of the process of adopting AI tools in medicine,” said Associate Professor McCradden, who is the lead of Project CANAIRI.

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This rounded off a busy year for the Amsterdam-based regulator which adapted to its new headquarters after a lengthy relocation from London, while also responding to global pandemic by working closely with companies developing new COVID-19 vaccines and medicines.

The Agency’s human medicines committee (CHMP) gave the green light for the following products in December:

• Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer.
• Heplisav B (hepatitis B surface antigen) for the active immunisation against hepatitis B virus infection.
• Inrebic* (fedratinib) for the treatment of primary myelofibrosis (an uncommon type of bone marrow cancer) and of myelofibrosis secondary to polycythaemia vera (a type of blood cancer) or essential thrombocythaemia (a rare chronic blood cancer).
• Lumoxiti* (moxetumomab pasudotox) for the treatment of relapsed or refractory hairy cell leukaemia, a cancer of a type of white blood cell called B-lymphocytes.
• Retsevmo (selpercatinib) for the treatment of cancers that display a rearranged during transfection (RET) gene fusion: RET-fusion positive non-small cell lung cancer, RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer.
• Rukobia (fostemsavir) for the treatment of multidrug resistant HIV-1 infection.
• Sibnayal* (potassium citrate / potassium hydrogen carbonate) for the treatment of distal renal tubular acidosis, a rare genetic disorder that affects the ability of the kidneys to remove acid from the blood.
• Tukysa (tucatinib) for the treatment of HER2-positive locally advanced or metastatic breast cancer.
• Kixelle (insulin aspart), for the treatment of diabetes mellitus; and Yuflyma (adalimumab), for the treatment of certain inflammatory and autoimmune disorders.
• Lenalidomide Krka (lenalidomide), for the treatment of multiple myeloma and follicular lymphoma; Lenalidomide Krka d.d. (lenalidomide), for the treatment of multiple myeloma, myelodysplastic syndromes, and follicular lymphoma; Lenalidomide Krka d.d. Novo mesto (lenalidomide), for the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma; and Sunitinib Accord (sunitinib), for the treatment of cancer.
• Ogluo (glucagon), a hybrid medicine for the treatment of severe hypoglycaemia in diabetes mellitus.

Nine recommendations on extensions of therapeutic indication were agreed for Bavencio, Doptelet, Iscover, Keytruda, Nplate, Nordimet, Plavix, Rinvoq and Spravato

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