DECIDE

DECIDE – Decision-Enabling Confirmation of Innovative Discoveries and exploratory Evidence – is the accompanying project within the BMBF funded consortium Richtlinie zur Förderung von konfirmatorischen präklinischen Studien – Qualität in der Gesundheitsforschung (Guidelines for Promotion of Confirmatory Preclinical Studies – Quality in Health Research (in German)).

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 trials phases, where the treatment is tested in patients under controlled conditions, efficacy of potential treatments needs to be confirmed through careful hypothesis testing and experimentation. 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 economic, social, and ethical levels.

To better understand evidence generation in preclinical studies, the BMBF started funding several preclinical confirmatory studies. As accompanying project within this consortium, the DECIDE project will support and counsel the preclinical study groups throughout the funding period. Further, DECIDE aims to identify success factors, and to develop a best practice guideline for confirmatory studies from a meta-analytic perspective.

As one output of DECIDE, a Guidance for planning and conducting confirmatory preclinical studies and systematic reviews was formulated. This document provides guidance for individual researcher or research groups that want to engage in a (multicenter) confirmatory preclinical study and/or systematic reviews. It is based on a review of current literature and interaction with confirmatory projects currently funded under the above mentioned call “Confirmatory preclinical studies – quality in health research” by the German Federal Ministry of Education and Research (BMBF).”