ADAPTIVE DESIGNS IN CLINICAL TRIALS: FROM SCIENTIFIC ADVICE TO MARKETING AUTHORISATION TO THE EUROPEAN MEDICINE AGENCY

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

Abstract Background In recent years, experience on the application of adaptive designs in confirmatory clinical trials has accumulated.Although planning such trials comes at the cost of additional operational complexity, adaptive designs offer the benefit of flexibility to update trial design and objectives as data accrue.In 2007, the European Medi

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Interlinking financial stability regulation and governance in German professional soccer: contribution and implications

IntroductionThis study explores the integration of financial stability regulation in professional soccer within the framework of sport governance, focusing on the German context.The research examines how financial regulations influence key governance principles such as accountability, transparency, and sustainability, while also addressing the chal

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