Grace Wangge

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BACKGROUND A non-inferiority (NI) trial is intended to show that the effect of a new treatment is not worse than the comparator. We conducted a review to identify how NI trials were conducted and reported, and whether the standard requirements from the guidelines were followed. METHODOLOGY AND PRINCIPAL FINDINGS From 300 randomly selected articles on NI(More)
BACKGROUND Non-inferiority (NI) trials in drug research are used to demonstrate that a new treatment is not less effective than an active comparator. Since phase IV trials typically aim at informing a clinical decision, the value of a phase IV non-inferiority trial hinges also on its clinical relevance. In such trials, clinical relevance would refer to the(More)
The active-controlled trial with a non-inferiority design has gained popularity in recent years. However, non-inferiority trials present some methodological challenges, especially in determining the non-inferiority margin. Regulatory guidelines provide some general statements on how a non-inferiority trial should be conducted. Moreover, in a scientific(More)
Non-inferiority trials: methodological and regulatory challenges Thesis, Utrecht University, with summary in Bahasa Indonesia and in Dutch This study was performed in the context of the Escher project (T6-202), a project of the Dutch Top Institute Pharma. The Escher project brings together university and pharmaceutical partners with the aim to energize(More)
Challenges of defining a non-inferiority margin: a case study of non-inferiority randomized controlled trials of oral anti-thrombolytic agents for prophylaxis of venous thromboembolic events after orthopedic surgery Objective To identify problems and difficulties in determining a non-inferiority (NI) margin using the case of NI rando-mized controlled trials(More)
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