Drug and medical device research involving humans is subject to many legal requirements and complex authorisation procedures. The Coordination Centre for Clinical Trials provides support with planning and implementation.
If researchers in Germany want to test drugs, medical devices or medical treatments on test subjects, they not only have to take scientific considerations into account, but also complex authorisation procedures. For good reason: the thalidomide scandal uncovered in the early 1960s showed the consequences of drugs that had not been carefully tested. Pregnant women who had taken the drug thalidomide for morning sickness were more likely to give birth to children with severe deformities. The tragedy made headlines around the world - and led to stricter rules for drug authorisation.
"Anyone who wants to research a new active ingredient or use it for purposes beyond the current admission must comply with numerous regulations. Researchers at universities are largely subject to the same requirements as large pharmaceutical companies," explains Dr Heike Hennig, Head of the Coordination Centre for Clinical Trials (KKS) Oldenburg. To ensure that doctors and scientists at the university do not have to face the associated jungle of paragraphs alone, the five-member KKS team supports them from the research question to the implementation of studies in the so-called "highly regulatory area" of clinical trials. Regardless of whether medical devices, drugs or medical treatments are to be researched as part of such studies, the KKS employees - most of whom hold doctorates themselves - accompany the process. With their work, they want to promote science-initiated clinical studies at the UMO, which, in contrast to industrial research, can also shed light on issues that are not motivated by profit.
Hennig and the team have three intensive years of development behind them, during which they first had to create the administrative, organisational, personnel and legal conditions for science-initiated clinical trials at University Medicine Oldenburg. Now their work is visible to the outside world for the first time. The "CHOCOMO" study by neuroscientist Prof Dr Christiane Thiel has been launched: The research team is investigating the effects of the approved Alzheimer's drug donepezil on brain performance in healthy volunteers. This research approach is subject to European regulations as well as the German Medicines Act. Appropriate authorisation was required for the study to be carried out - the KKS team provided intensive support during this process.
The team not only advised on the study design, but also subsequently submitted the proposal to the European Medicines Agency via the Clinical Trials Information System. The responsible higher authority, the Federal Institute for Drugs and Medical Devices, reviewed the planned study together with the responsible ethics committee. The KKS team prepared the proposal with great care; it took around a year to compile all the documents. Then came the approval. "This is a milestone for us. Hopefully many more UMO clinical trials will now follow," says Hennig.
However, the work of the KKS team does not end with the successful completion of the approval process, as it also supports the active study phase. The team's data manager supports the researchers in setting up a study-specific database that meets the requirements of good clinical practice (GCP) as well as those of the relevant European regulations and national laws. "The successful submission encourages us to support further clinical research projects at the highest level and thus make Oldenburg even more attractive as a research location," says Hennig.
"We also visit the facilities where the study is being conducted and check whether the researchers are complying with the regulations and recording their results correctly," says Dr Andreas Molitor, Deputy Head and Quality Manager of the KKS. This monitoring is an important duty of the university, which is legally responsible for the study as the so-called "sponsor". Monitoring ensures patient safety and data quality.
The services offered by the KKS are therefore not limited to the mere approval procedure, but also include numerous activities in the areas of study design, biometrics, data and project management, cost calculations and quality assurance, ranging from feasibility testing of a study idea to assistance with manuscripts for scientific publications, depending on requirements.
With this advisory and support programme, the KKS aims to support the work of scientists who want to pursue their own questions in the context of clinical studies. "This research sheds light on aspects that are of no interest to the pharmaceutical industry or medical device manufacturers due to their lack of profit prospects, but are extremely important for those affected by rare diseases or therapy optimisation, for example," emphasises Hennig.
Hennig and Molitor, who both previously worked at the Coordination Centre of the University Medical Centre Göttingen, have experienced the direct positive effects for patients themselves on several occasions. For example, a scientifically initiated study was able to show that children suffering from a certain type of renal insufficiency benefit from a drug that had not previously been admitted for this indication. Used correctly, it can delay the often necessary dialysis. The result of another non-commercial study made it possible to reduce antibiotic prescriptions in the GP sector for uncomplicated urinary tract infections. "Questions and results such as these can often only be achieved through science-initiated studies that are not commercially driven," says Molitor.
