"FDA Commissioner Marty Makary announced 'the first ever real-time clinical trial' at a press conference, stating, 'Today is a milestone day for us to challenge the assumption that it takes 10 to 12 years for a new drug to come to market.'"
"'The goal here is to sort of get to a regulatory decision in a faster timeline, without compromising any safety,' said FDA Chief Artificial Intelligence Officer Jeremy Walsh, emphasizing the importance of maintaining safety standards."
"'When a patient develops a fever, or a tumor shrinks, FDA regulators can see in the cloud, in real-time, exactly what is happening,' Makary explained about the pilot's capabilities."
The FDA has launched a pilot program utilizing artificial intelligence and cloud computing to monitor clinical trial data in real time. This initiative aims to reduce the lengthy approval process for new drugs, which traditionally takes 10 to 12 years. FDA Commissioner Marty Makary highlighted that nearly 45% of the time during clinical trials is spent on paperwork. The program allows for direct data feeds from trials, enabling real-time monitoring of clinical endpoints. The FDA emphasizes that safety will not be compromised despite the potential to shorten trial durations by up to 40%.
Read at Nextgov.com
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