Medical Xpress February 25, 2025
A paper in the Journal of the National Cancer Institute finds that almost 20% of patients in middle-stage cancer drug trials receive treatment that eventually proves effective enough to get FDA approval. This may have important implications for drug development and clinical trial recruitment.
The development of new medications typically has three stages. In Phase I trials, researchers assess drugs for safety and dosing (“What is the best tolerated dose for the patient?”). Phase II clinical trials determine whether a new drug shows signs of efficacy (“How much does the drug reduce disease?”).
Drugs showing promise in Phase II are then evaluated in Phase III trials, which are conducted at multiple centers with at least several hundred patients and often...