The FDA released draft guidance on the use of AI and ML in drug development in May 2023. Image credit: Shutterstock / grandbrothers

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

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).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.