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Half of trials supporting new cancer drug approval in Europe had high risk of bias

BMJ 2019; 366 doi: (Published 19 September 2019) Cite this as: BMJ 2019;366:l5619

Linked Research

Design characteristics, risk of bias, and reporting of RCTs supporting approvals of cancer drugs by EMA

  1. Elisabeth Mahase
  1. The BMJ

Researchers have called for tougher regulations on approving cancer drugs in Europe after they found that many drugs were licensed on the basis of poorly designed trials that included no data on whether the drugs helped patients to live longer.

Around half of the trials that supported new cancer drug approvals in Europe from 2014 to 2016 were judged to have a high risk of bias, indicating that the treatment effects might have been exaggerated, the team found in a study published by The BMJ.1

Researchers from the UK, the US, and Canada assessed the randomised controlled trials (RCTs) that were used to support the approval of new cancer drugs by the …

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