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BMJ 2004;329:457 (21 August), doi:10.1136/bmj.329.7463.457
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EDITORThe theme issue on balancing benefits and harms in health care highlighted the need to create better systems to detect and share information about adverse events associated with newly licensed drugs or drugs used off licence or for indications not supported by evidence from clinical trials.1 2 3
A new project, CICERO (www.pacehealthsystems.com/cicero.html), proposes to create a global online database to record the outcomes and adverse events related to the use of investigational and newly licensed treatments. The internet offers distinct advantages to paper journals and is not geographically restricted. This is essential because we need to identify potential adverse events early after the global release of new treatments. Unlike clinical trials, internet reporting will be less selective and has the potential to detect events in untested subpopulations. It may therefore generate truer estimates of efficacy and adverse events in the general population.
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Voluntary reporting systems such as
Paul L Cervi, consultant haematologist
Basildon Hospital, Essex SS16 5NL paul.cervi@btuh.nhs.uk
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