ArticleJournal of pharmaceutical health services research : an official journal of the Royal Pharmaceutical Society of Great Britain2016
Accuracy of pharmaceutical company licensing predictions: projected versus actual licensing dates.
Article in Journal of pharmaceutical health services research : an official journal of the Royal Pharmaceutical Society of Great Britain, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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4 authors at 2 institutions in 1 country.
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Abstract
objectivesTo determine the accuracy of pharmaceutical companies' predictions of drug licensing timeframes for their products in late stage clinical development.
methodsWe compared predicted licensing dates provided to the National Institute for Health Research Horizon Scanning Research and Intelligence Centre by pharmaceutical companies against actual marketing authorisation application (MAA) and marketing authorisation (MA) dates published by the European Medicines Agency for drugs granted authorisation between 2009 and 2013. KEY
findingsOne hundred and twenty-three drugs met our inclusion criteria. About 78% were new drugs and 16% had orphan designation. Less than half (44%) and less than a quarter (24%) of MAA and MA predictions respectively were considered accurate (same month or 1 month either side of the actual date). Pharmaceutical companies were significantly more accurate in predicting MAA dates than MA dates (
conclusionsEven in predicting near events from well-informed sources, accuracy is imperfect. There appears to be an optimum time for the provision of accurate information on predicted MAA and MA dates for drugs. This information is crucial for effective early awareness and alert activities.
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