26 DRUG REACTIONS Postmarketing surveillance studies require refinement Results of a retrospective analysis in the UK ' ... suggest tllat company sponsored post-marketing surveillance studies • •• IIave made little contribution to regulatory monitoring of drug safety over tile past four years.' The analysis included 31 observational cohort studies which satisfied the current quadripartite guidelines for conducting postmarketing surveillance studies in the UK; these guidelines were published in 1988. Many of the studies were poorly designed, with less than optimal sample sizes, potential for selection bias and lack of inclusion of comparator groups. Although they emphasise that their conclusions are preliminary, the study's researchers, from the Medicines Control Agency and the CSM, suggest that addressing these issues of study design will help to increase the value of such studies. They also recommend that postmarketing surveillance studies should focus more on specific potential safety issues. Furthermore, logistic problems in patient recruitment and adequate provision of information to regulatory authorities need to be resolved. To achieve these goals, the quadripartite guidelines will need to be revised and discussions are underway. Waller PC. Wood SM. Langman MJS. Breckenridge AM. Rawlins MD. Review of company post marketing surveillance studies. British Medical Journal 304: 1470-1472.6 Jun 1992 1031 13 Jun 1992 ISSN 0156-2703/92/0613-0026/$1.00/0 © Adi. IlIIematianal lid

Postmarketing surveillance studies require refinement

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26 DRUG REACTIONS

Postmarketing surveillance studies require refinement

Results of a retrospective analysis in the UK ' ... suggest tllat company sponsored post-marketing surveillance studies • •• IIave made little contribution to regulatory monitoring of drug safety over tile past four years.' The analysis included 31 observational cohort studies which satisfied the current quadripartite guidelines for conducting postmarketing surveillance studies in the UK; these guidelines were published in 1988.

Many of the studies were poorly designed, with less than optimal sample sizes, potential for selection bias and lack of inclusion of comparator groups. Although they emphasise that their conclusions are preliminary, the study's researchers, from the Medicines Control Agency and the CSM, suggest that addressing these issues of study design will help to increase the value of such studies.

They also recommend that postmarketing surveillance studies should focus more on specific potential safety issues. Furthermore, logistic problems in patient recruitment and adequate provision of information to regulatory authorities need to be resolved.

To achieve these goals, the quadripartite guidelines will need to be revised and discussions are underway. Waller PC. Wood SM. Langman MJS. Breckenridge AM. Rawlins MD. Review of company post marketing surveillance studies. British Medical Journal 304: 1470-1472.6 Jun 1992 1031

13 Jun 1992 INPHARMA~ ISSN 0156-2703/92/0613-0026/$1.00/0 © Adi. IlIIematianal lid