Recommendations for robust and reproducible preclinical research in personalised medicine.

Personalised medicine (PM) is a medical model that aims to provide tailor-made prevention and treatment strategies for defined groups of individuals. The concept brings new challenges to the translational step, both in clinical relevance and validity of models. We have developed a set of recommendations aimed at improving the robustness of preclinical methods in translational research for PM. These recommendations have been developed following 4 main steps: 1) a scoping review of the literature with a gap analysis, 2) working sessions with a wide range of experts, 3) a consensus workshop and 4) preparation of the final set of recommendations. Despite the progress in developing innovative and complex preclinical model systems, there are fundamental deficits in translational methods that prevent further development of PM. We identified five points of focus for the recommendations, based on the consensus reached during the consultation meetings: 1) clinically relevant translational research; 2) robust model development; 3) transparency and education; 4) revised regulation; and 5) interaction with clinical research and patient engagement. Appropriate preclinical models should be an integral contributor to interventional clinical trial success rates and predictive translational models are a fundamental requirement to realise the dream of PM. Here, we present a set of 15 recommendations aimed at improving the robustness of preclinical methods in translational research for PM.

FOSSE Vibeke;  OLDONI Emanuela;  BIETRIX Florence;  BUDILLON Alfredo;  DASKALOPOULOS Evangelos;  FRATELLI Maddalena;  GERALCH Bjorn;  GROENEN Peter;  HOLTER Sabine M;  MENON Julia M.L.;  MOBASHERI Ali;  OSBORNE Nikki;  RITSKES-HOITINGA Merel;  RYLL Bettina;  SCHMITT Elmar;  USSI Anton;  ANDREU Antonio;  MCCORMACK Emmet; 

2023-01-11

BMC

JRC129834

1741-7015 (online),   

https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-022-02719-0,    https://publications.jrc.ec.europa.eu/repository/handle/JRC129834,   

10.1186/s12916-022-02719-0 (online),