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.
Only 10 of those 39 trials, or 26%, measured overall survival as a primary endpoint, while the remaining 29 trials evaluated surrogate measures, which may not predict whether a patient will live longer or have a better quality of life. Quality of life was reported in 17, or 44%, mainly as a secondary outcome. Overall, 19 trials, or 49%, were considered to be at a high risk of bias because of problems in design, conduct, or analysis, according to the study published in The BMJ.