The purpose of patient-oriented clinical research is to integrate up-to-date research findings into clinical practice. Clinical trials are research studies involving human participants, which are conducted in order to test new medicines or to evaluate innovative treatments or diagnostic tests. Clinical trials are subject to strict legal requirements, and are conducted in accordance with internationally-accepted ethical and scientific standards. At all times, the rights, safety and wellbeing of trial participants are of paramount importance.
Every year, Charité hosts more than 800 clinical trials, covering a wide range of specialties and conditions. The large majority of these studies are initiated by Charité researchers (known as IIT or investigator-initiated trials), with funding provided by public funding bodies (BMBF, DFG, EU), foundations and partners from industry.
Its outstanding research environment also makes Charité an attractive partner for pharmaceutical and biotechnology companies (contract research).
Coordinating Center for Clinical Studies (KKS)
KKS is one of the faculty's centralized service facilities. Its primary aim is to support Charité research staff (IITs) during the planning, set-up and conduct of clinical trials. These trials include those that fall under the scope of the AMG (Medicinal Products Law), the MPG (Act on Medical Devices, and other trials. The organizational and administrative support provided means that researchers are freed up to focus on their clinical and research work.
The center aims to facilitate the conduct of high-quality studies that comply with both international standards and German legal requirements, are conducted in accordance with the relevant Good Clinical Practice guidelines, and meet all relevant patient safety and data protection requirements.
In order to provide comprehensive support services, the KKS focuses on its proven core competencies in the areas of budget planning, regulatory affairs, biostatistics, monitoring, IT and data management, and pharmacovigilance. In addition to this, the KKS Academy offers training courses for staff involved in clinical research and the opportunity to gain additional qualifications.
Clinical Trial Management Unit (CTMU)
The founding of the Clinical Trial Management Unit (CTMU) in 2013 saw our support service offerings expanded to industry-sponsored clinical trials, with support made available to both private companies and Charité research staff.The CTMU is the main point of contact and source of advice on all issues pertaining to the initiation of clinical trials. The CTMU is responsible for attracting new trial partners, as well as providing trial coordination services and expertise. It is also involved in developing strategic partnerships, optimizing internal processes, and promoting the communication and dissemination of relevant clinical trial-related information.As an integral part of the research environment at Charité, the CTMU is responsible for the main testing phases of pre- and post-licensing studies (phases II-IV). By cooperating with private partners, we are hoping to be able to offer our help to any departments looking for additional support.
We have so far forged strategic partnerships with three large clinical research organizations (CROs) conducting research work on behalf of private sponsors (pharmaceutical companies). The CTMU's remit is purely administrative in nature and does not include the conduct of clinical trials. This ensures that its business interests do not clash or compete with those of Charité's clinical departments.