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Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency.

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第一作者： Olivier,Collignon

第一单位： European Medicines Agency, 30 Churchill Place, London, E14 5EU, UK. olivier.collignon@ema.europa.eu.;Competence Center for Methodology and Statistics, Luxembourg Institute of Health, 1A-B, rue Thomas Edison, L-1445, Strassen, Luxembourg. olivier.collignon@ema.europa.eu.

作者： Olivier,Collignon ^[1] ; Franz,Koenig ^[2] ; Armin,Koch ^[3] ; Robert James,Hemmings ^[4] ; Frank,Pétavy ^[5] ; Agnès,Saint-Raymond ^[5] ; Marisa,Papaluca-Amati ^[5] ; Martin,Posch ^[2]

作者单位： European Medicines Agency, 30 Churchill Place, London, E14 5EU, UK. olivier.collignon@ema.europa.eu.;Competence Center for Methodology and Statistics, Luxembourg Institute of Health, 1A-B, rue Thomas Edison, L-1445, Strassen, Luxembourg. olivier.collignon@ema.europa.eu. ^[1] Section for Medical Statistics, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. ^[2] Institut für Biometrie, Medizinische Hochschule Hannover, OE 8410, 30625, Hanover, Germany. ^[3] Medicines and Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, London, SW1W 9SZ, UK. ^[4] European Medicines Agency, 30 Churchill Place, London, E14 5EU, UK. ^[5]

关键词 Clinical trials regulation Interim analysis Sample size re-assessment Seamless phase II/III Stopping for futility