AstraZeneca, Amgen partner with FDA to test real-time AI trial monitoring
Investing.com -- The US Food and Drug Administration announced Tuesday a plan to reduce drug development timelines by monitoring clinical trials in real time, potentially cutting months or years from the approval process.
The agency will track high-level signals about experimental drug safety and efficacy as trials progress, though it will not collect all patient-level data, FDA Chief AI Officer Jeremy Walsh said on a call with reporters.
The initiative aims to make the US more competitive for drug research as companies increasingly choose to launch trials in China and Australia, FDA Commissioner Marty Makary said. The White House budget has indicated the FDA plans to offer new options to expedite early-stage trials, which would benefit small biotech companies.
The FDA published a notice Tuesday requesting information on using artificial intelligence to accelerate early clinical research, which it described as a critical bottleneck in drug development.
Makary said drug development typically takes 10 to 12 years, with approximately 45% of that time spent on paperwork and data entry.
Under the current system, drug companies receive results from study sites, analyze the data, and then submit it to the FDA. Providing regulators with access to data as it is collected could allow companies to advance drugs to the next phase of clinical trials more quickly, Walsh said.
The approach is being tested in trials of two cancer drugs conducted by AstraZeneca (NASDAQ: AZN) and Amgen (NASDAQ: AMGN). The program was developed in partnership with industry, Walsh said. A broader pilot program will follow.
FDA leadership said the initiative is not meant to replace communication and meetings with drug developers.
