Main Research Topics
Research is integrated in the current scientific process, i.e. in the exchange of information, in contacts, in co-operation and public relations. The regulatory work of the Federal Institute for Drugs and Medical Devices (BfArM) profits from research activities of the institute. Research brings new knowledge to all regulators enhancing their competence in the decision making process. Being internationally competitive means focussing on few key areas, and therefore the BfArM has defined two main topics in its current research program, both subdivided into three modules:
TOP 1: Effects of medicinal products and medical devices
- Module 1: Impulse conduction
- Module 2: Inflammation
- Module 3: Cellular dysfunction
TOP 2: Methodological research
- Module 1: New test methods
- Module 2: Epidemiology and Biometrics
- Module 3: Clinical research
Effects of medicinal products and medical devices (TOP 1) are directly linked to one of BfArM’s central tasks: the assessment of effects of medicinal products and medical devices. The topic has been defined deliberately as broad as that to include both desired and undesired effects. It becomes more specific by its three modules, which do all contain future-trend topics and, moreover, coincide with core topics of the EMEA .
- The "Impulse conduction“ module includes the effects of medicinal products and medical devices on excitable tissues like the heart, the nervous system or the musculature. In the focus are projects on potassium channels in the heart, cardiac pacemakers and the central nervous system (CNS).
- The "Inflammation" module includes inflammable processes in association with the effects of medicinal products and medical devices. Links are possible to such projects as the function of neutrophilic granulocytes and blood clotting.
- The "Cellular dysfunction" module includes the effects of medicinal products and medical devices on the cell itself, above all damaging effects on the (DNA). Tumour biology projects are in the focus of this module .
Methodological research (TOP 2) ist also linked with BfArM's core capabilities.
- The modules "New test methods" and "Epidemiology and Biometrics" rely on projects in the area of chemicophysical drug analysis and biometrics. Epidemiological research activities are planned to be extended. Especially the pharmacovigilance has the potential for doing this part of research and further scientific activities are intended.
- The “Clinical research“ module will strengthen BfArM’s competence in this field. However, the BfArM does not have the means to conduct clinical studies of its own or finance external clinical studies. So "Clinical research" will exploit BfArM’s core capabilities in the analysis of clinical studies and identification of important topics for clinical studies. The BfArM has developed core capabilities in the generation and assessment of study designs, elaboration of guidelines, evaluation of data sets of individual clinical studies or in the context of meta-analyses. Lack of relevant studies is identified and communicated by the pharmacovigilance unit and the expert group for paediatrics and juvenile medicine (EAKJ). The capabilities shall be concentrated in the "Clinical research" module to systematically identify problems and develop solutions. Communication of results to the scientific community is another focal point and a way of initialising clinical studies.
The two topics and their modules are of equal value and not department specific. They shall be a platform across the existing organisational structures for all collaborators interested in research, thus advancing interdisciplinary communication and scientific exchange at BfArM.
The main research topics and their modules include basic and applied works. Basic and applied works are not mutually exclusive, on the contrary, they are integrated in the departmental research (Ressortforschung) conducted at BfArM. It is our aim to establish high-ranking, nationally and internationally competitive research, and to meet the statutory requirement for departmental research (as laid down in the BGA-Nachfolgegesetz / Federal Health Office Succession Act). To achieve this aim we need to raise third-party funds and apply the right in-house award criteria. By competitiveness, flexibility, and organic growth, BfArM will gain status and position. BfArM’s scientific advisory board accepted the research topics and modules at the meeting of 14 June 2004.
If a research project is allocated to one of the two research topics or one of the modules it has fulfilled a crucial criterion for being supported. Other investigations are possible as well, especially in topical areas or in areas recommended by the scientific council. Investigators should seek to link their work to the adopted research topics. Principally, research support at BfArM is project-related. Yet, support of platforms and service units outside adopted projects shall be possible as well. No formal organisational structures are planned to be installed within the research modules. It is left to the modules themselves to find their form of organisation. In the current phase the topics have been defined relatively vague so as to allow for dynamic development including the possibility of abandoning less successful topics or establishing new modules.