Fragility Analysis of Phase III Trials Supporting FDA Approval of Anticancer Drugs

July 17, 2019 – In an analysis reported in The Lancet Oncology, Del Paggio and Tannock found that many phase III trials supporting U.S. Food and Drug Administration (FDA) approval of anticancer drugs have a low fragility index—a measure of how many people in a study would have had to have a different outcome in order for the findings to become not statistically significant—indicating a lack of robustness in the demonstration of superiority over control treatments … (leggi tutto)