Almost half of all cancer drug trials show bias and exaggeration

pharmafile | September 19, 2019 | News story | Research and Development BMJ, Cancer, cancer drug trials 

New research on clinical trials between 2014 and 2016 raise “serious concerns about low standards” as over the three year period trials showed high elements and risk of bias as well as exaggeration of treatment effects.

The research was published in the British Medical Journal and claims that there are “serious concerns about low standards of evidence supporting new cancer drugs”. The BMJ research also states there is a definitive need to improve the design, conduct, analysis and reporting of these trials.

In 2017 more than one quarter of the European Medicines Agency (EMA) approvals were for cancer treatments.

In evaluating the flaws of these trials, international researchers examined the bias risk and reporting of randomised trials over the three year period. In that time, the EMA approved 32 new drugs on the basis of 54 studies, of which 41 or 76% were randomised controlled trials.

The research underlined the point that only 10 studies or 26% measured overall survival as a primary or main endpoint. The other 29 trials or 74% looked at the indirect measure of benefit, which does not necessarily predict whether or not a patient will live longer or have an improved quality of life.

Moreover 19 trials or 49% were judged to be at high risk of bias because of problems with their design, conduct or analysis – all in all, trials that properly evaluated overall survival were at low risk of bias.

Cancer specialists have however pointed out that research and treatment is a complex area and overall in the cancer market, survival rates are improving.

Earlier this year Germany’s health Technology Assessment agency (Institute for Quality and Efficiency in Healthcare) assessed 82 new cancer drugs and indications between 2011 and 2017 and found that 39% had no proof of added benefit.

With an increasing reliance on single armed trials to support cancer drug approvals, the research ultimately highlights that trial evidence alone is not sufficient but quality assessment of that evidence is also required to ensure these trials accurately estimate treatment effects.

Nik Kiran

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