Staburo at the 9th Pharm-Tox Summit in Munich 

Imagine you are tasked with designing a phase II dose finding study to come up with a suitable dose for phase III. To accomplish this, the invited talk by Gabriele Bleckert from Staburo GmbH at the 9th German Pharm-Tox Summit in Munich on 14 March 2024 within the AGAH session gave good directions.

Ten years ago, the Multiple Comparison Procedure and Modelling (MCP-Mod) Methodology was qualified by regulators as an efficient statistical methodology for model-based design and analysis of phase II dose finding studies under model uncertainty.

The talk showcased two clinical trials in the indication Schizophrenia and Diabetes where MCP-Mod has been implemented successfully. MCP-Mod was motivated and key features of the methodology were explained with focus on MCP-Mod at analysis stage. Planning of MCP-Mod trials was elaborated in the subsequent talk by Sebastian Bossert from Boehringer Ingelheim.

Many thanks to Ruwen Böhm and Barbara Schug from SocraTec who chaired the AGAH (Arbeitsgemeinschaft für Angewandte Humanpharmakologie e. V.) session for inviting us to share our insights on MCP-Mod. Special thanks to Sebastian Bossert for the illuminating exchange on MCP-Mod.

Data analysis, clinical biostatistics and more.