“The use of an artificial intelligence-based platform to analyze forms is expected to save Food and Drug Administration reviewers of adverse drug report about 7,500 hours per year.”
“ABBYY’s Digital Intelligence platform transforms as many as 120 fields in safety reports on potential adverse interactions during clinical drug trials into structured content that reviewers can check at a glance. Previously, reviewers had to manually study each of the 40,000 safety reports FDA receives each year before a drug goes on the market and review 2 million reports a year after it’s released, said Justin Scott, senior business informatics officer at FDA’s Office of Business Informatics.”
“To review the reports, analysts would open each file and spend about 10 minutes reading it. For about 10% of the forms, they would spend another 15 to 20 minutes writing a review about a likely relationship between the reaction and the drug, he said. That alone added up to about 1,000 hours, he added.”
“Now, the analysts get extracted and structured information so ‘they can basically go to a series of reports, take a glance at it and understand, ‘All right, this is how many people took this product and were hospitalized, this is how many of them were hospitalized and subsequently died,’’ Scott said. Analysts can now quickly gather high-level information ‘instead of having to open dozens and dozens of documents and take notes,’ he said. ‘Before, where they might get fatigued from reading all these PDFs and notes, now they have the data just presented right in front of them…’”
“The implementation of the platform is part of FDA’s larger Technology Modernization Action Plan, which came out at the end of 2019. The agency aims to address the silos that have grown around its component organizations based on their various responsibilities: oversight of human drug products, food, cosmetics, animal products and medical devices, for example…” Read the full article here.
Source: AI analysis speeds FDA drug reviews — By Stephanie Kanowitz, March 31, 2021. GCN.
