This article was provided by APM Heatlh Europe from their coverage of the recent World Drug Safety Congress Europe 2013.
LONDON, Sept 12 (APM) – Major drug companies make decisions on whether to act on safety signals using human judgement, despite the vast amount of pharmacovigilance data and statistical tools now available, a conference heard.
Unlike clinical trials, where statistical analysis shows whether a drug is meeting pre-defined safety and efficacy endpoints, making decisions on drug safety based on pharmacovigilance data is not such an exact science, delegates heard at the Wednesday event.
Dr Alan Hochberg, process development and drug safety communications office at Roche, told the conference that despite the range of information available, he triggers internal action on safety signals when he has “the urge to write a report” which may be well ahead of when the statistics show there may be a problem.
This approach is necessary because of the nature of data being assessed and potential safety signals can be masked by the presence of other drugs, particularly in the field of oncology where patients are often taking other drugs, Hochberg told the World Drug Safety Congress.
“Just because the signal is confounded by other medications does not mean that the signal is not there. Just because you are paranoid does not mean that they are not after you.”
Raise safety signals early, but not too early
Sometimes it was necessary to leave a suspected signal for several months to see if further cases emerge to give further evidence, although leaving cases for too long can raise the ire of regulators. “It is possible to assess a signal too early,” said Hochberg.
Christina Strom Moller, vice president, patient safety late development and marketed products, at AstraZeneca, added: “When the teams come to me with their signals, the information comes from different sources.
“When you feel you should write a report on this – that is when the signal is valid,” she said.