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Post-marketing studies: broken promises

Pharmaceutical companies rarely fulfil their promises to conduct trials after a marketing authorisation has been granted. All the more reason to demand full evaluation data before granting approval.

In recent years, clinical trials conducted after the granting of a marketing authorisation for a drug have become frequent, in particular because health authorities sometimes want further information on a drug’s risk-benefit balance in real-life situations.

An official report from the USA reveals that pharmaceutical companies there have a poor track record in fulfilling their obligations to carry out clinical trials after being granted a marketing authorisation: lack of information on the progress of the trials, uncompleted trials, and even promised trials that had still not begun several years after the drug received a marketing authorisation.

A report from the French Senate identifies a comparable situation, with a large proportion of trials not yet started, even after several years.

These findings show that clinical trials carried out after a marketing authorisation has been granted in no way represent a reliable alternative to thorough evaluation ahead of time. Examination of the marketing authorisation application is a key opportunity for the authorities to obtain data from pharmaceutical companies. After the marketing authorisation has been granted, the balance of power is such that companies can get away with not fulfilling their obligations, or with deferring them for a long time while they push sales.

©Prescrire February 2007

Source: "Essais cliniques après commercialisation : des promesses non tenues" Rev Prescrire 2007 ; 27 (280) : 137-138. - More articles in Prescrire's "Spotlight"...