Europe’s Two-headed Monster: Divergent Demands For Comparators Squeeze Rx Trials
This article was originally published in The Pink Sheet Daily
Medicines agencies and HTA bodies often ask for different clinical trials, and industry has become concerned that additional studies will cost too much and delay market access.
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The Executive Director of the European Medicines Agency Guido Rasi’s dual goals of increasing safety and overall accountability undoubtedly will benefit patients and industry alike, but a grueling task lies ahead.
Germany’s health technology evaluator’s rejection of GSK’s Benlysta and Biogen Idec’s Fampyra could force companies to design separate trials for authorization and HTA assessment.
IQWiG turned down both GSK/Valeant’s Trobalt and Novartis’ Rasilamlo for lack of evidence of added benefit, after manufacturers’ choice of comparator deviated from those selected by the G-BA.