The news: The FDA plans to use AI for real-time clinical trial tracking to speed review times for new drugs, starting with two proof-of-concept trials with Amgen and AstraZeneca.

• Amgen is running a phase 1 trial for a lung cancer treatment, while AstraZeneca is conducting a phase 2 trial for a lymphoma treatment.
• The FDA is also seeking public comment as it weighs a broader pilot program that could start as early as August.

Why it matters: The FDA last year outlined broad plans to expand its use of AI across the drug and medical device review process and already uses both generative AI (genAI) and agentic AI to assess submissions.

The proposed use of AI for real-time clinical trial oversight could further shorten drug development timelines.The new process will use AI to pull study data from electronic health records (EHRs) for real-time submissions, replacing the current time-intensive, multistep workflow of data collection, analysis, formal submission, and FDA review. 45% of the time from early stage trials through final submission is spent on paperwork and administrative tasks, FDA chief Marty Makary said. FDA Chief AI Officer Jeremy Walsh said the new AI approach could cut trial timelines by “months, if not years,” per Bloomberg.

Implications for pharma companies: As the FDA expands its AI use across the drug lifecycle—including clinical trials, submissions, reviews, manufacturing inspections, and direct-to-consumer ad monitoring—pharma companies will need to adapt to more automated, data-driven regulatory processes.

The proposed use of AI for clinical trial oversight could mark one of the biggest shifts. If it becomes standard, study design will need to be more digital, AI-compatible, and ready for earlier regulator assessment. While the proposal could speed approvals, it would also change how drug development and review work. Companies used to periodic data collection, analysis, and submission will need to shift to a continuous, always-on data flow, limiting their ability to reconcile inconsistencies or shape a narrative before regulators review the data.

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