BMJ--Lessons from the withdrawal of rofecoxib
Posted by Clark Venable on 10/14/2004
British Medical Journal: Lessons from the withdrawal of rofecoxib:
""Suggested measures to ensure drug safety before definite licensing of a drug:
- Legal requirement for drug companies to register all randomised controlled trials prospectively
- Legal requirement for drug companies to make all data on serious adverse events from clinical studies publicly available immediately after study completion
- Continuously updated systematic reviews of adverse events based on published and unpublished data from randomised controlled trials and observational studies
- Phased introduction of new interventions in independent, large scale, randomised trials before definite drug licensing
- Clear cut financial firewalls between pharmaceutical companies and researchers performing systematic reviews and clinical studies
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