Biased by design? Clinical trials and patient benefit in oncology
A recent study examined the risk of bias and standard of reporting of clinical trials which resulted in the approval of new drugs for cancer treatment, in Europe, during the period 2014-2016 *.
Almost half of these trials were assessed as biased. Only about a quarter measured overall survival as an end point. There was often disparity between the results reported when compared to the stated purpose of the trials.
For many new cancer drug approvals a single pivotal drug trial was deemed sufficient, whereas for other medical conditions multiple supporting trials are required before approval is granted. Pivotal trials tend to be non-randomised, not double blind and usually incomplete.
In many cases, subsequent confirmatory trials, after approval, have shown no improvement in overall survival and frequently the initial findings are not replicated. This study suggests there is a major weakness in the approval process with often little patient benefit.
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