NEW YORK – Over half of new cancer drug approvals granted by European authorities between 2014-2016 may have been made based on evidence from biased clinical trials, according to a new study published in The BMJ. The study, led by Dr. Christopher Booth, professor of oncology from Queens University Cancer Research Institute, raises serious questions about the quality and strength of evidence used by the European Medicines Agency (EMA) to approve new cancer drugs.

Half of the 32 new drug approvals relied on evidence from trials that were “at high risk of bias,” according to the study. And an additional 7 of those used results from at least one randomised-control trial (RCT) that was at “low risk” of bias, researchers found in the study, which was partially funded by a civil society group that has protested cancer drug prices and championed access to medicines issues.

Only 7 of the new drugs were approved based on trials that actually measured improvements in survival or quality of life outcomes.

Noting that some bias in trials is unavoidable due to the complexity of cancer, the authors were concerned that a number of studies did not give clear reasons for why they may have excluded data from their analyses.

While the authors note that the results may not be generalizable to all new drug approvals, civil society groups were quick to say that the

paper strengthens the case for revamping  the drug approval regulatory process to ensure that new medicines brought to market are indeed effective.

“…Many newly marketed medicines bring negligible or non-existent improvements to survival rates and quality of life for patients, while becoming ever-more unaffordable to already stretched health systems,” Jaume Vidal, senior policy advisor at Health Action International, the group that partially funded the study in a press release.

“Regulators must take on the findings to help ensure new medicines on the market are there for the benefit of the patient and society and not pharmaceutical companies and shareholders.”

 The World Health Organization tends to follow the lead of regulatory agencies such as the EMA or the US Drug and Food Administration in the consideration of new medicines for “pre-qualification” as drugs that developing countries could obtain at negotiated prices. WHO approval, in turn, may be interpreted as a green light to developing countries to begin reviewing and registering new therapies nationally.

Image Credits: WHO/ G. Reboux.