Scientific Expertise – an important Foundation of Clinical Research
EU projects and their importance for contract research
The European Food Safety Authority (EFSA) only allows health-related claims in advertisements or on the packaging of food products, if these are convincingly evidenced by scientific studies. The EFSA’s quality requirements for such studies are therefore very high. Alongside excellent regulatory knowledge, scientific expertise is thus of central importance in clinical studies.
The scientific aspects of study planning thereby include:
• A thorough review of the scientific literature to establish the current state of knowledge on the active ingredient and presumed effect mechanism
• Knowledge of and experience with tried and tested as well as new and innovative methods suitable to demonstrate effectiveness
• Profound statistical understanding to interpret publications and plan clinical studies
Errors in these areas can have a serious impact on study results, completely distorting results in the worst case.
A research institute cannot employ experts from all clinical fields itself. Therefore it is of elementary importance to cooperate intensively with a network of internationally recognized experts. At daacro, this is made possible by our scientific advisory board on the one hand and our participation in scientific projects funded by the European Union on the other hand.
Daacro has been a partner in the FP7-funded research project “Neurobiology and Treatment of Adolescent Female Conduct Disorder: The Central Role of Emotion Processing” since 2013. This international research project is investigating conduct disorders (CD) in children and youth (direction: Prof. Christine M. Freitag, University Hospital Frankfurt am Main) from diverse perspectives. The project’s aim is to expand knowledge on CD, especially in girls, and enable improved therapy. The consortium is comprised of 17 European partners (including 13 universities) from 8 countries. Daacro’s saliva lab is participating in this research project, providing consultation, the organization of sampling materials, sample analysis, data transfer and biostatistical support.
In 2016, daacro received a further research grant: Alongside two French firms Bionov (Robertet Group) and V@si, daacro is part of the Eurostars project ActiveNutraLife*, which is developing a product that aims at accelerating the healing process of leukemia patients after chemotherapy. This new approach combines nutritional supplements, an online activity programme and novel stress diagnostics to measure individual exhaustion (cancer fatigue). Such ActiveNutraLife* kits are later to be distributed by health insurance providers. Within this project, daacro will develop a new variation of the stress diagnostics system neuropatternTM. neuropatternTM is a procedure, which enables an individualized diagnosis of stress-related disorders based on psychological, biological and symptomatic information. Results can be differentiated into 13 stress-related endophenotypes, the so-called “neuropatterns”. The version adapted for leukemia patients, called HEMO-neuropattern, concentrates on endophenotypes of exhaustion.
These two highly diverse research projects well document the daacro team’s scientific recognition and reintroduce expert panels’ current state of knowledge into our work.
*ActiveNutraLife – A new complementary medicine approach for the management of chemotherapy side effects