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Evaluation of new drugs:
no to "non-inferiority" trials

Drugs offering no proven therapeutic benefits are being approved thanks to so-called "non-inferiority" clinical trials.

It is disgraceful that pharmaceutical firms can obtain marketing approval for drugs on the basis of so-called "non-inferiority" clinical trials.

"Non-inferiority trials" allow drugs to obtain approval on the grounds that they generally appear no worse than the treatments to which they have been compared. And that is sufficient for the health authorities not to withhold marketing approval. In other words, it is just one step from "non-inferiority" to "non-refusal"; the authorities grant the marketing approvals and the firms concerned are happy.

But no therapeutic benefits have been demonstrated. The efforts of the thousands of patients who took part in the trials have not helped improve treatment one iota. This was set down in the trial protocol, but were the patients clearly informed?

And yet patients and health professionals urgently need decisive improvements leading to reduced mortality, improved quality of life and fewer adverse effects.

Participating actively in well-designed trials that aim to demonstrate tangible advances is in the interests both of patients and of health professionals. Without wasting a single second either on "non-inferiority" trials, nor on the ensuing non-improvements.

©Prescrire October 2008

Source: "Non-infériorité = non-progrès". Rev Prescrire 2008; 28 (299): 645.

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