Coordination Center for Clinical Studies
A Coordination Center for Clinical Studies (KKS) supports doctors and scientists in clinics and practices with scientific study support in the implementation of clinical research projects. For this purpose, a KKS provides human, spatial and logistical resources at the location of patient care, research and teaching. Anchored at a university clinic, a coordination center or center for clinical studies (ZKS) also has the task of training and further educating staff for the special requirements of clinical studies. The KKS / ZKS are united throughout Germany in a network, the KKS-Netzwerk e. V. (Network of Coordination Centers for Clinical Studies), which supports the policy to improve research conditions.
Tasks of a coordination center
A coordination center for clinical studies (KKS) or center for clinical studies (ZKS) has the task of supporting the planning and implementation of medical research projects on humans. It offers specific study support in the context of the development of new drugs, medical devices and therapy principles for national and international study projects. As a scientific service provider, a KKS / ZKS contributes to the implementation of clinical studies at medical faculties / university clinics and affiliated hospitals, in particular scientifically initiated research projects (Investigator Initiated Trials, IIT for short). The basic goal is to successfully coordinate all processes of clinical studies with the necessary support and to realize high-quality studies according to international standards.
KKS / ZKS mainly offer services for the following types of studies:
- Clinical trials in accordance with Phases I-IV of the Drugs Act
- Clinical tests in accordance with the Medical Devices Act
- Studies in accordance with the professional regulations for doctors such as therapy studies on non-drug therapy forms, for example in surgery or psychotherapy; Studies to evaluate diagnostic procedures; Studies on the prognosis of diseases; Methodological issues in clinical research.
Study support is aimed primarily at doctors and scientists in clinics and practices as well as at public facilities and institutions. The KKS / ZKS also cooperate with national and international study groups and specialist societies as well as with companies in the pharmaceutical and medical technology industries.
The training, advanced and advanced training of study staff in classroom courses, workshops and part-time master’s courses are also part of the tasks of a coordination center.
Range of services
The scientific services of the KKS / ZKS in the context of clinical research into the effectiveness and / or safety of drugs, medical products or innovative therapeutic principles are diverse. The following list gives an overview of the general range of services:
- Advice, study planning and coordination
- Assessment of feasibility / feasibility of studies in clinics / practices (feasibility)
- Budget planning, financing and funding advice
- Government and ethics filings
- Project management
- Quality management including monitoring and support in preparation for audits and inspections
- Biometrics and data management
- Provision of validated IT systems
- SAE management / pharmacovigilance
- Site management / support of study implementation
- Documentation, publication and archiving.
All services of the KKS / ZKS for planning, implementation, evaluation and reporting are considered individually depending on the project, depending on what support a scientist actually needs.
Development history
The planning, implementation and evaluation of clinical studies require a high level of clinical and methodological competence. Until the mid-1990s, there was generally no professional infrastructure and logistics for clinical research at German university locations. Germany threatened to lose touch with international clinical research. From 1999 to 2009, the Federal Ministry of Education and Research (BMBF) funded the establishment of a total of 13 “Coordination Centers for Clinical Studies” (KKS) with a total of around € 29 million, in order to provide qualified study support and methodology for clinical research projects in the German university system to anchor. From the very beginning, the KKS were committed to the goal of sustainably improving science-driven clinical research in Germany and ensuring that clinical studies were carried out in accordance with international GCP (Good Clinical Practice) standards. They continue to strategically pursue this mandate even after the funding has expired.
From 2007 to 2015, the BMBF is funding individual clinical study centers with a further € 45 million with the aim of establishing sustainable structures for the coordination and implementation of patient-related clinical research at the trial center. In addition to equipping the clinics involved with the necessary resources, the expansion of study competence through decentralized study units and the training of study staff were promoted. The development of the clinical study centers usually takes place under the direction of the existing local KKS.
In the meantime, coordination centers or comparable facilities based on the model of the KKS / ZKS have been established at many initially unsupported locations of the 37 medical faculties in Germany, some of which have joined the network of coordination centers for clinical studies (KKS network).
Creation of the KKS network and its objectives
The networking of the initially funded KKS was set down from the start and consistently pursued with the aim of expanding the nationwide quality offensive at academic locations and establishing standards across the board.
In 2004 a working group of the coordination centers (KKS-AG) was founded as a cross-university institution. In 2005 the KKS-AG had a more official character: the working group was transformed into the network of the coordination centers for clinical studies (KKS network). The KKS network has been a registered association since 2017. Knowledge and information are exchanged in the KKS network and methods and standards are defined. The KKS network is organized through an office in Berlin as a service, communication and information platform.