Input Stories

The Food and Drug Administration is aiming to use artificial intelligence to speed up clinical trials of new medicines (The Wall Street Journal, subscription).

What’s going on: Through a pilot program the FDA is set to launch this summer, “AI would extract data directly from electronic records so they can be submitted in real-time to both the FDA and the pharmaceutical company.”

• “Typically, medical centers involved in clinical trials pull study data from electronic-health records and enter them manually into a data-capture system. Then, the drug company developing the medicine reviews the data and submits them to the FDA.”
• The pilot—whose AI capabilities will be provided by startup Paradigm Health—will include five to nine drugmakers.

Why it’s important: “If successful and adopted widely, the new approach could speed drug development and help the U.S. compete with other nations making a strong push into biotechnology, officials said.”

• “In addition to enabling data to be reviewed quickly, the real-time reporting could make clinical trials more accessible to people who live far from academic medical centers, where trials have typically occurred, said Dr. Paul Burton, senior vice president and chief medical officer of Amgen.”

Amgen and AstraZeneca: “As a prelude to the pilot, drugmakers AstraZeneca and Amgen agreed to test real-time data reporting in clinical trials of specific cancer medicines.”

• Amgen is doing site selection for its trial, which will focus on patients with limited-stage small cell lung carcinoma.
• “The University of Pennsylvania and the University of Texas MD Anderson Cancer Center are participating in the AstraZeneca study of patients with treatment-naïve mantle cell lymphoma.”