The benefits of new cancer drugs continue to be exaggerated in reporting of key trials, it was alleged today.
Writing in The BMJ, experts claim that patients are at risk of harm if drugs are approved on the basis of exaggerated evidence.
This may include the "intangible" harm of false hope and failure to organise palliative care.
In the journal an international team of experts, led by Professor Huseyin Naci, of the London School of Economics, UK, report on an analysis of trials used to support approval by the European Medicines Agency.
Over a three-year period, the agency approved 32 new cancer drugs backed by 54 pieces of research, of which 41 were randomised control trials.
The researchers studied the 39 published trials and found that just ten had overall survival as a primary endpoint. Others used surrogate measures.
They say that 19 trials were flawed and were at "high risk of bias."
There were further concerns about ten of the drugs and these "rarely" surfaced in the scientific literature, the researchers say.
This should lead doctors and decision-makers "to carefully consider risk of bias in pivotal trials that support regulatory decisions, and the extent to which new cancer therapies offer meaningful benefit to patients," they say.
Design characteristics, risk of bias, and reporting of randomised controlled trials supporting European Medicines Agency approvals of cancer drugs, 2014-2016: Cross-sectional analysis. BMJ 19 September 2019
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