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SCOPE: FDA facilitates AI and ML use for clinical trials and drug development

The US Food and Drug Administration (FDA) is focusing on how artificial intelligence (AI) can be used to support clinical trials but says it will take time to get there, as per a regulatory official speaking at the SCOPE Summit.

The role of AI and ML was at the centre of a fireside chat taking place on the third day of the Summit in Orlando, which has been a gathering point for those in the clinical trial strategy and operations field.

Marsha Samson, who works in the CDER office focusing on AI and machine learning (ML) said trial sponsors have told her the main reason they have not been using AI as much as they could is that they were concerned about how the FDA would receive it. She went on to highlight that the FDA has contact lines for those involved in trials to get in touch so they can run their practices by the agency to ensure compliance.

In May 2023, the FDA released its guidance for AI and ML for drug development and has since published a discussion paper on the topic.

The paper has received more than 600 comments about AI is being used, said Samson, adding that more submissions to the FDA are being made using AI.

Due to accelerated drug development over the past years, which is partially a result of the most recent technologies, drugs are no longer [just] treating symptoms but diseases, said Kevin Bugin, deputy director of operations for the Center for Drug Evaluation and Research (CDER).

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By GlobalData

Samson concluded that all the FDA wants to do is bring drugs to patients safely and quickly.

According to GlobalData analysis, the market for AI in pharma is projected to nearly triple in value from $1.5bn in 2019 to $4.3bn in 2024.

Additionally, it is forecasted that there will be $3.3bn worth of spending on AI in drug discovery by 2025, more than triple the $1bn spent in 2019, with a year-on-year growth rate of 24.4%.

GlobalData is the parent company of the Clinical Trials Arena.

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