Recent advances in biomedical research provide innumerable opportunities to develop novel preventive and therapeutic strategies. However, only a small fraction of biomedical discoveries are successfully translated into clinical applications. Potential 'breakthrough' therapies, which are spectacularly successful in animal models of disease, often fail in clinical trials. This translational bottleneck imposes burdens on research and healthcare systems, as well as patients who participate in trials of novel strategies.
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The Department of Experimental Neurology acknowledges and honors the trust and expectations which society, funders, scientists and above all patients put into the quality and value of our research. Currently, there is wide consensus that the biomedical sciences, especially its preclinical domain, are afflicted by a systemic quality problem. Reference is often made to the dearth of structured measures for quality control, as practiced for example in research in the pharmaceutical industry or as is standard in clinical practice and trials. Therefore, the Department of Experimental Neurology has taken up the challenge to overcome this problem by systematically developing and implementing into its own work quality assuring measures while safeguarding that this does not impact on the creativity and originality of our research.
From 2014 -2017 we have obtained certification for conformity with a DIN EN ISO 9001:2008 quality management system. Few, if any, academic preclinical research labs worldwide comply with this norm. However, working with ISO and its certification exercises we were doubtful whether they had major positive impact on our research. On the other hand, working under ISO 9001 clearly drained resources. Consequently we have decided against recertification and embarked on a process in which we are developing and implementing a bespoke QM system which is tailored to academic biomedicine, consisting of "building blocks" of quality-ensuring measures that are modular, scalable, practicable, financeable and acceptable to our researchers and their personel.
In this quest we are supported by the Volkswagenstiftung, who generously provides funding for our project PREMIER: Productiveness and Robustness through Modular Improvement of Experimental Research, which started in October 2017. PREMIER strives to develop a quality assurance system for academic preclinical research that can be deployed to and implemented in other workgroups, departments, or institutions.
In addition, we are an enthusiastic partner of EQIPD, a joint European academic-industry consortium funded by the Innovative Medicines Initiative of the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA). EQIPD (European Quality In Preclinical Data) also aims to develop a simple, flexible, efficient quality assurance system, based on empirical evidence, to improve the rigor and robustness of preclinical neuroscience and safety research in academia as well as in pharmaceutical industry.
The PREMIER project has been registered at the Open Science Framework.
In our efforts to improve the quality of biomedical research the Department of Experimental Neurology tightly collaborates with the QUEST Center for Transforming Biomedical Research of the Berlin Insitute of Health. International collaborations include leading scientists in meta-analysis and quality improvement in preclinical research (e.g. M. Macleod, UK; J. Ioannidis, US; D. Howells, AUS); organizations (e.g. CAMARADES, EQUATOR, METRICS, NC3R), as well as pharmaceutical companies active in this field (e.g. Novartis, SANOFI, Pfizer).
A first review of PREMIER is published in the EMBO Journal.