DECIDE Interview Study Protocol - Knowledge Claim Update

Preclinical research explores potential novel therapies with the ultimate goal of bringing these therapies to patients. This is known as translation of scientific knowledge from basic to applied clinical research. However, before entering the clinical trial phase, where the treatment is tested in patients, efficacy of potential treatments needs to be confirmed through careful hypothesis testing and experimentation in preclinical model systems. Unfortunately, translational failures are frequent. Here, clinical trials cannot hold up to promising preclinical results, creating a translational gap. This has implications not only on a medical, but also on an economic, social, and ethical scale. To address these challenges and to better understand evidence generation in preclinical research, the German Federal Ministry for Research, Technology and Space (BMFTR) funded several preclinical confirmatory studies. These consortia aim to confirm exploratory findings across various biomedical research fields in a rigorously planned and executed multi-laboratory set-up. Alongside these preclinical research projects, the meta-research project DECIDE (Decision-Enabling Confirmation of Innovative Discoveries and exploratory Evidence) was funded to provide methodological support and collectively investigate confirmatory study design and experimental outcomes.