Post-marketing studies safety evaluation

There has never been any incentive for the pharmaceutical industry to pursue research along these lines even though, as in the case of Vioxx, the end results of neglecting adverse effects may be very costly. The aim of the industry has usually been to extend the market size irrespective of potential risk and attempts to implement effective post-marketing surveillance has received little enthusiasm. It is to be hoped that company medical departments and pharmaceutical physicians will continue to support the need for a broad range of safety evaluation studies to be conducted on new medicinal products. 

These guidelines apply to the conduct of all company-sponsored studies which evaluate the safety of marketed products. They take the place of previous guidelines on post-marketing surveillance which were published in 1988 (BMJ, 296 399-400). Studies performed under those guidelines were found to have some notable limitations (BMJ, 1992, 304 1470-1472) and these new guidelines have been prepared in response to the problems identified. The major changes maybe summarised as follows ... 

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