A TIME newsletter highlights how artificial intelligence is reshaping the most expensive and time-consuming part of drug development — clinical trials, rather than just speeding up drug discovery. Although AI has accelerated early stages of research, the number of new drugs approved each year hasn’t changed much, largely because clinical trials remain a bottleneck that often takes years and hundreds of millions of dollars to complete. AI firms, like Formation Bio, are now using generative AI to streamline administrative tasks — such as patient recruitment, regulatory filings, and data analysis — claiming they can cut trial timelines in half and drastically reduce operational costs.
Formation Bio’s approach focuses on optimizing what happens around the treatment period rather than the biological testing itself. By automating repetitive knowledge work, the company argues fewer human staff can handle more trial workflows — potentially broadening access to therapies and enabling smaller, more efficient biotech firms to thrive. Their business model involves acquiring promising drug candidates, running AI-assisted trials, and selling successful programs to big pharmaceutical companies, with lucrative deals already completed with firms like Sanofi and Eli Lilly.
Beyond administrative efficiencies, broader industry data underscores how AI can improve patient recruitment, protocol design, and safety monitoring — traditional pain points that often delay or derail clinical trials. AI tools can analyze vast medical records and health data to match suitable candidates faster or continuously monitor participant responses, which may lead to better trial outcomes, fewer costly delays, and a more patient-centric research experience. Global market reports also project rapid growth in AI-enabled clinical trial technologies, reflecting expanding adoption across biotech and pharma sectors.
Despite these advantages, challenges remain — including regulatory acceptance, data quality concerns, and ensuring AI tools act reliably and ethically in a field where patient safety is paramount. Nevertheless, TIME suggests that as AI transitions from niche research tools to core components of the clinical trial pipeline, it could reshape how medicines are tested, approved, and brought to patients, marking a significant shift in the economics and speed of drug development.
