Updated: Oct 9
“Phase 1 cancer studies, which guide dose selection for subsequent studies, are almost 3 times more prevalent than phase 3 studies and have a median study duration considerably longer than 2 years, which constitutes a major component of drug development time.”
It takes a long, long time for new cancer treatments to get through the necessary clinical trials and reach FDA approval. The median duration for phase 1 oncology trials is around 32 months, and late-stage trials (phases 2 and 3) have seen their times steadily rise in recent years. It stands to reason that if you can safely reduce trial duration, then these life-saving therapies can become available sooner.
But is there a safe and effective way to reduce phase 1 oncology trial duration?