Planning preclinical confirmatory multicenter trials to strengthen translation from basic to clinical research – a multi-stakeholder workshop report

Natascha Ingrid Drude, Lorena Martinez-Gamboa, Meggie Danziger, Anja Collazo, Silke Kniffert, Janine Wiebach, Gustav Nilsonne, Frank Konietschke, Sophie K. Piper, Samuel Pawel, Charlotte Micheloud, Leonhard Held, Florian Frommlet, Daniel Segelcke, Esther M. Pogatzki-Zahn, Bernhard Voelkl, Tim Friede, Edgar Brunner, Astrid Dempfle, Bernhard Haller, Marie Juliane Jung, Lars Björn Riecken, Hans-Georg Kuhn, Matthias Tenbusch, Lina Maria Serna Higuita … & Ulf Toelch
Abstract Clinical translation from bench to bedside often remains challenging even despite promising preclinical evidence. Among many drivers like biological complexity or poorly understood disease pathology, preclinical evidence often lacks desired robustness. Reasons include low sample sizes, selective reporting, publication bias, and consequently inflated effect sizes. In this context, there is growing consensus that confirmatory multicenter studies -by weeding out false positives- represent an important step in strengthening and generating preclinical evidence before moving on...
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