The U.S. Food and Drug Administration (FDA) is looking to deploy artificial intelligence to achieve real-time evaluation of clinical trial results to accelerate the time frame it takes to develop and bring new drugs to the market. To that end, the watchdog has tapped drugmakers AstraZeneca (AZN) and Amgen (AMGN) to conduct two proof-of-concept trials.
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The FDA is also launching a broader pilot program to achieve this goal and has begun taking inputs from industry stakeholders — a process it said will last until May 29.
FDA Takes a ‘Modern Approach’
Typically, drugmakers conduct clinical trials in partnership with medical centers, with results compiled manually from electronic health records for submission to the FDA. This process can last for several years, leading to an elongated drug development process.
However, the FDA wants to change this and is counting on AI to help significantly boost the process of collecting and submitting study data. The agency’s commissioner, Marty Makary, said the “modern approach” means the agency will be able to view safety profiles and trial target data in real time as the studies progress.
“With improvements in AI and data science, sponsors and trial sites have the opportunity to conduct real-time trials in a way that enhances safety monitoring and radically increases efficiency,” the health agency noted in a statement.
How AstraZeneca and Amgen Come In
As part of the FDA’s efforts, AstraZeneca is conducting a Phase 2 multi-site study called TRAVERSE to develop treatment for patients suffering from mantle cell lymphoma, a type of blood cancer. Eligibility is limited to patients who have not received any treatment.
Amgen, on the other hand, is planning an early-stage, or Phase 1b STREAM-SCLC trial for patients with small cell lung carcinoma, an aggressive type of lung cancer. The trial focuses only on patients whose cancer is confined to one side of the chest, that is, those with limited-stage small cell lung carcinoma.
Which Healthcare Stock Is the Better Buy?
Of the two drugmakers highlighted in the article, TipRanks’ Stock Comparison tool shows that AstraZeneca offers the significantly larger upside of about 19%. This is based on an average price target of $222.41 that comes with a Moderate Buy rating.
