EU-PEARL researchers Marta Bofill Roig and Pavla Krotka talk about statistical issues in platform trials at the Spanish IBS

18th Conference of the Spanish Section of the International Biometric Society, organized by the Carlos III University of Madrid and Rey Juan Carlos University, was held from 25 to 27 May in Madrid, Spain. EU-PEARL researchers Marta Bofill Roig and Pavla Krotka participated with two oral presentations in contributed sessions.

Pavla Krotka presented the extended abstract “Operating characteristics of a model-based approach to incorporate non-concurrent control in platform trials”, which she has co-authored with Martin Posch and Marta Bofill Roig. During her talk in the plenary session for young researchers, she focused on regression models for treatment-control comparisons in trials with non-concurrent controls. She showed the behaviour of the corresponding hypothesis tests in terms of type I error rate and statistical power in the presence of time trends. In particular, she evaluated the proposed model approach through simulations under a wide range of scenarios of platform trials with multiple treatment arms and a shared control, outlining under which conditions the modeling approach leads to valid statistical inference.

In the Biomedical Methods session, Marta Bofill Roig showcased the work “Current statistical issues in platform trials for the evaluation of multiple treatments”. She discussed the major statistical challenges, such as the adaptivity of platform trials (decisions on adding or dropping arms cannot be fully pre-specified but may have an impact on current trial arms), multiplicity issues (due to multiple interventions, subgroups and interim analysis) and the use of shared controls (non-concurrent controls and blinding for interventions that have different routes of administration, change in the standard of care). Especially, she centred the talk on the optimal allocation problem in platform trials.

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