AI tool aims to accelerate clinical trial patient recruitment
Phase 3 MS trials to be first to use tool from collaborative venture
An artificial intelligence (AI)-based tool called Muse aims to accelerate drug development by optimizing clinical trial patient recruitment.
The tool, designed as part of a collaboration among Formation Bio, OpenAI, and Sanofi, is designed to be implemented across a range of areas. Sanofi will first put it to the test in upcoming Phase 3 trials involving people with multiple sclerosis (MS).
The company is currently developing two therapies for MS, frexalimab and tolebrutinib. A Formation Bio press release announcing the Muse launch didn’t say which, if either, of them would be tested in the clinical trials. Formation Bio also plans to put Muse to use in a trial setting, the companies said.
“By leveraging advanced AI capabilities, we can not only enhance recruitment efficiency but also potentially bring new treatments to patients faster,” Emmanuel Frenehard, Sanofi’s chief digital officer, said in the press release. Muse “represents another proof point in Sanofi’s journey to becoming the first pharma company powered by AI at scale,” he said.
Patient recruitment for clinical trials is commonly a slow and expensive part of drug development, and often less than 10% of patients participate in clinical trials. These challenges significantly delay trial completion, directly impacting how quickly new treatment become available to patients.
AI develops patient profiles, targets recruitment
Muse aims to accelerate patient enrollment by developing recruitment strategies and producing high-quality recruitment materials that target diverse populations.
First, the AI tool does an extensive analysis on existing scientific literature and insights regarding each disease, its patient population, and existing therapies. Based on the data, it then defines the optimal patient profile for a given study and delivers recruitment strategies to include those patients.
Muse also can auto-generate recruitment materials and pre-screening questionnaires to reach specific patient subgroups. This may help researchers more easily reach historically under-represented groups, which could diversify patient representation in clinical trials.
The tool speeds tasks that typically require large teams and extensive reviews, the companies said. They said it may also contribute to obtain more reliable data that more accurately represents the real-world patient population for a given disease, leading to more equitable treatments.
“AI presents a tremendous opportunity to transform drug development, ultimately enhancing both efficiency and outcomes,” said Ben Liu, PhD, Formation Bio’s co-founder and CEO. “At scale, this AI-driven development approach can accelerate the delivery of new medicines and reshape healthcare worldwide.”
Muse is equipped with a large language model (LLM) agent, a tool used to create complex tasks and adapt them as needed. The agent used in Muse was developed to incorporate institutional review board and regulatory guidelines, allowing it to generate materials that comply with best practices.
The LLM feature, “when combined with human experts in the loop, reduces the risk of regulatory setbacks, promoting smoother, more efficient trial progression,” the press release said.
“We believe AI can accelerate drug development, bringing new treatments to patients more quickly,” said Brad Lightcap, OpenAI’s chief operating officer. “This first product from our collaboration with Sanofi and Formation Bio is just the beginning, and we can’t wait to see the impact it will have.”
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