Effect of cross-over in oncology clinical trials on evidence levels in early benefit assessment in Germany

13 June 2018 - In oncology clinical trials, cross-over is used frequently but may lead to uncertainties regarding treatment effects. ...

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Atezolizumab, pembrolizumab, nivolumab in urothelial carcinoma: studies of direct comparison are useful

4 January 2018 - Four dossier assessments involving comparisons between immunotherapies and chemotherapies for the same therapeutic indication in 2017/comparison ...

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German watchdog calls for direct comparison of cancer immunotherapies

16 January 2018 - Germany’s drug assessment body has criticized a lack of data directly comparing drugs in a promising ...

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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 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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