Patient reported endpoints underrepresented in product information on new drugs

15 December 2021 - An IQWiG team analysed the extent to which patient reported outcomes, which were recorded as endpoints ...

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New drugs: where did we go wrong and what can we do better?

10 July 2019 - More than half of new drugs entering the German health care system have not been shown to ...

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Finding RCTs of new drugs: searches in trial registries require specific adaptations

5 January 2018 - In their article in the Journal of Clinical Epidemiology, Marco Knelangen, Elke Hausner, Sibylle Sturtz, and ...

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German body calls for pause in European plan for fast track drug approval

16 August 2016 - Plans by the European Medicines Agency to expand its fast track approach to approving new drugs have ...

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German agency criticizes European program for speeding some drug approvals

15 August 2016 - in pointed remarks, Germany’s cost-effectiveness watchdog has criticized an effort by European regulators to accelerate approval ...

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Adaptive pathways: EMA still leaves open questions unanswered

9 August 2016 - Current EMA report on the pilot project again documents perplexity regarding the use of “real world data”. ...

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