Clinical studies: How Oldenburg's KKS paves the way to healing!

Clinical studies: How Oldenburg's KKS paves the way to healing!

The safety of patients in medical research is the focus of current discussions. In Germany, drug and medical device research is bound to strict legal requirements. These regulations ensure that innovative therapeutic approaches can be examined with the utmost care. UOL.de reports that the Coordination Center for Clinical Studies (KKS) plays a crucial role in the approval process by supporting researchers in planning and conducting these studies.

In Germany, scientists have to go through complex approval procedures in order to be able to test new drugs and medical devices. This is done taking into account the lessons learned from the Contergan scandal of the 1960s, which led to significant tightening of approval guidelines. Dr. Heike Hennig, head of the KKS Oldenburg, and her five-person team accompany the entire process from formulating the research question to implementing the study.

The meaning of the KKS

The KKS aims to promote science-initiated, non-profit clinical studies. This is happening in an environment where health innovations are often not viewed by the pharmaceutical industry as economically viable, even though they can be crucial for affected patients. Studies such as “CHOCOMO,” which examines the effects of the Alzheimer’s drug donepezil on the brain, are examples of such research projects. This study required comprehensive approvals in accordance with European regulations and the German Medicines Act.

The KKS team closely monitored the approval process and submitted the application to the European Medicines Agency via the Clinical Trials Information System. After a year of preparation, approval was granted. During the active study phase, the KKS supports researchers in areas such as study design, data management and quality assurance to ensure a high level of patient safety and data quality.

Ethical guidelines in research

The basics of medical research on humans were developed in the Declaration of Helsinki of the World Medical Association. These guidelines, which were adopted in 1964 and revised several times, most recently in 2013, have the well-being and protection of patients as their top priority. In addition, clinical trials must be approved by independent ethics committees and responsible authorities before they begin.

In addition to checking the ethical acceptability, these commissions also assess the scientific quality of the study projects. Close cooperation between the sponsors of the studies, mostly pharmaceutical companies, and the research institutions is essential. Each study must submit a detailed study protocol that clearly describes the aim and methodology.

Adhering to strict guidelines makes it possible to develop new treatment methods and prevent dangerous errors. The probability that applications for approval will be approved in a modified manner by the Federal Institute for Drugs and Medical Devices is 95 percent. However, it is important to note that this regulation also applies to the project's experience with a variety of disease types, including cancers and neurodegenerative diseases.

Overall, the work of the KKS Oldenburg shows how important it is to maintain the balance between innovative research and patient safety. Ongoing monitoring and support of studies ensures that essential data is collected that promotes both progress and patient well-being.