Open-label extension studies: do they provide meaningful information on the safety of new drugs?

@article{Day2007OpenlabelES,
  title={Open-label extension studies: do they provide meaningful information on the safety of new drugs?},
  author={Richard O. Day and Kenneth Mapson Williams},
  journal={Drug safety},
  year={2007},
  volume={30 2},
  pages={93-105}
}
The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. If undertaken primarily to gather more patient-years of exposure to the new drug in order to understand and gain confidence in its safety profile, open-label extension studies can play a useful and legitimate role in drug development and therapeutics. However, this… CONTINUE READING

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