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News Release - Queen's University researcher uncovers issues with non-inferiority trials for cancer drugs

Friday, August 30, 2019

From: Queen’s University

News release

(August 2019) Queen’s University researcher Bishal Gyawali (Oncology, Public Health Sciences) recently completed a study that uncovered a number of problems with non-inferiority trials in regards to cancer drugs.

The research showed that using non-inferiority design was not justified in 40 per cent of the trials and that industry funding of trials was associated with the lack of justification.

Dr. Gyawali explains cancer drugs are prescribed to patients based on the results from trials. Usually these are superiority trials, meaning the cancer drugs prove that they are better than the treatments being used. Recently, more and more cancer drugs are approved based on non-inferiority trials where it’s proven that the new drugs are not worse than the treatments already being used, instead of proving they are better.

Such an approach is considered justified if the new drugs provide any other benefit such as a lower cost, the drug is easier to administer, or shows an improved quality of life.

The research was published in JAMA Network Open.


“The general public should care about this research because if they have cancer and are receiving drugs, they should know if the drugs they are taking have been proven superior or only non-inferior. In case the drug was proven non-inferior, they should be aware of what the margin of non-inferiority was.”

“Authorities should take steps to make sure the non-inferiority trials are justified in their design and ask for patient input to define the criteria for non-inferiority.”

- Bishal Gyawali, Department of Oncology, Department of Public Health Sciences, Queen’s University


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Anne Craig

Media Relations Officer

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