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Post-market follow-up studies:
lack of transparency

It is essential to follow up on drugs after their release onto the market. However, very few results are ever published.

As new drugs gain approval with increasing ease and speed, pharmaceutical companies and drug regulatory bodies are postponing certain trials until the post-market follow-up period. Such follow-up studies, conducted under different conditions from the clinical trials, are vital for establishing the benefit-harm balance for widely used drugs. But pre-approval evaluation should not be any less stringent, and the post-market follow-up results should be made public.

The current lack of transparency around post-market follow-up studies is unacceptable. The French and European drug regulatory bodies have still not set up a register such as the one in the USA, keeping track of companies' pledges to carry out follow-up trials and studies. It is difficult to find out exactly what studies and trials have been requested, since the protocols, the monitoring of progress, and the results are almost never made public. The few studies and trials that do get published appear only after a long delay, and are often lacking in detail.

Post-market trials and studies should be carried out to address pertinent questions. Pharmaceutical companies must be sanctioned if they fail to fulfil their commitments. Regulatory bodies ought to publish the results, in order to improve the use of the drugs concerned.

©Prescrire December 2007

Source: "Suivi post-AMM : où sont les résultats ?" Rev Prescrire 2007 ; 27 (290) : 897-898.

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