STAT Plus: Flawed trials supported half of recent approvals of cancer drugs in Europe, study says
As drug makers race to bring cancer treatments to market, a new study finds about half of the supporting clinical trials for cancer medicines recently approved in Europe had a high risk of bias, underscoring concerns about approval standards and exaggerated benefits for patients.
Concerned about potential flaws in design, analysis, and reporting of studies, the researchers examined randomized, controlled trials used to win approval in Europe for cancer drugs from 2014 to 2016. During that time, the European Medicines Agency approved 32 new cancer medicines based on 54 studies. Of these, 41, or 76%, were randomized and controlled, but publications were available for only 39.
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