Task 5.2: Design a European adaptive RCT to improve survival in patients with SARI

The optimal design of a Bayesian adaptive RCT requires pre-trial simulation to determine the best overall structure, stopping and decision rules, sample size, and resulting power, and to evaluate the effects of potential relationships between treatments and proposed end-points. These simulation studies allow determination of the practical number of study arms and the number of baseline conditions upon which randomisation can be stratified. We plan to design a trial that efficiently estimates the benefit associated with each of multiple interventions for SARI. We will simulate the known and unknown contributors to patient enrolment, allocation, and outcome for proposed interventions identified in Task 1. After initial simulations, we will present simulation output to the PREPARE trial leadership for clinical evaluation. We will then modify the proposed trial design and parameters of the simulation, based upon this feedback, and conduct additional simulations to evaluate our refined our approach.

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Herman Goossens


Deputy Coordinator:

Menno de Jong




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