Off with the training wheels: AI-based patient characterization can improve clinical trial performance without large data sets

[Adobe Stock]

Only 12% of new drug candidates that enter phase 1 clinical development ultimately receive FDA approval. This dismal success rate leaves millions of patients with unmet medical needs and drives up the costs for the small number of drugs that make it to market. More frustratingly, it leaves untold numbers of potentially transformative therapies back-burnered or discarded entirely, not because they don’t actually provide benefit, but because they were tested in trials that weren’t effectively designed to demonstrate benefit. The true failure hasn’t been in drug innovation but in identifying the patient traits that govern clinical trial outcomes.

The big challenges of big data methodologies

Artificial intelligence (AI) holds great promise in improving this success rate by providing data-driven approaches to identifying traits and their combinations that enable more effective paradigms to enrich patien…

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