Staburo poster presentation at PSI 2018

Staburo poster presentation at PSI 2018

Staburo Managing Director Dr. Hannes Buchner will present the enhanced rank-preserving structural failure time method (eRPSFT), to adjust for treatment switching in 3-arm superiority trials. Meet Hannes personally at the PSI 2018 conference “Breaking Boundaries in Drug Development” from 3rd to 6th June 2018 in Amsterdam.

Introduction to the topic

Rapid progress in oncology and the according approvals of medications leads to fast and frequent change in the standard of care (SOC). Therefore, in trials with more than 2 arms, the comparison between investigational therapy (A) and former SOC (C), and the comparison between treatment (A) and alternative treatment therapy (B), the new SOC, are of interest. With new effective treatments, some of the patients will switch from treatment B or SOC therapy at some time point during the study period to treatment A. Treatment switching is not just an issue for economic evaluation. It is a problem for clinical and economic assessment.

Conclusions from our work

The enhanced RPSFT performed good with small bias for the calculations. Calculated confidence limits from the RPSFT model containing the true expected HR, for every comparison made. The uncorrected HR overestimates the true effect much more than the corrected HR. Only the confidence limits of the comparison of A vs. B in each scenario for the uncorrected HR contains the true expected HR, all other confidence limit exceed the HR. eRPSFT improves the estimation and should be used to adjust for treatment switching in 3-arm superiority trials.

If you are interested in Crossover Correction methods in Oncology, feel free to approach our colleague Hannes at PSI 2018 in Amsterdam or send us an email to info@staburo.de.