BMJ says more than half of European cancer trials are ‘biased’

The paper published by the BMJ examined 41 cases between 2014-2016 that were used to support the approval of 32 cancer drugs. The researchers found that 19 of them (41%) were at high risk of bias for their primary outcome, with the issue of bias arising because of missing data or by the parameters used to measure efficacy.

Trials that used overall survival as the primary endpoint (26% of the sample) were less likely to be at risk of bias than those that used surrogate endpoints such as progression free survival. With researchers further pointing out a substantial shift towards the use of surrogate studies in cancer trials. However, it is also important to note that in some cases bias risk ‘may be unavoidable’ due to the complexity of cancer trials.

There have been some suggested changes to approaches for the validity of trials, with many physicians facing big obstacles in trying to make treatment decisions but struggling to make supported choices due to methodological details of the trial data being scattered across different documents.

Physicians would like a standardized approach to collating and communicating information about the validity of trials, with suggestions including a risk of bias assessment in European Public Assessment Reports published by the EMA.

Additional suggestions include that the European Clinical Trials Register also demand the submission of a bias assessment alongside their trial results.

There is a concern that the rush to get new cancer drugs to patients as quickly as possible is starting to raise serious concerns about low standards of evidence supporting new cancer drug approvals.

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