The Coordination Centre for Clinical Trials (KKS) is a central element of the Faculty of Medicine at Düsseldorf’s Heinrich Heine University. The KKS supports clinical, primarily multi-centre trials taking into consideration Good Clinical Practice (GCP) and academic criteria, relating to both admission-relevant trials and exclusively academically focused trials.
Furthermore, the KKS’ staff train tutors and offer further training courses (for example for academic assistants, monitors or clinical researchers in rotation). They organise and hold further training events on the subject of clinical trials, In addition, the KKS provides methodological know-how on request. Within the context of its activities, the KKS also processes genuinely academic issues.
High-quality clinical trials in medicine involve a necessary, established basis for practice and are imperative for the purpose of evidencing the therapeutic benefit and absolute safety of forms of therapy. Only when the transfer of know-how functions from basics research and patient-oriented research through to routine application and vice versa can it be ensured that medical progress is actually implemented to the benefit of the patient.
By setting up coordination centres for clinical trials, the Federal German Ministry of Education and Research has established structures which are intended to improve the quality of clinical trials and further develop competence in this sector. The KKS in Düsseldorf has evolved from the theoretical surgery sector and was founded in 1999.
Patient Care
Within the context of clinical trials which extend beyond the borders of the immedi-ate region, the KKS’ staff at Düsseldorf University Hospital regularly check new diagnostic methods and innovative therapeutic approaches in line with strict criteria with regard to ethics and data protection. As a rule, participation in clinical trials entails a better level of care for the patient.
The KKS supports all aspects of clinical trials and assists the clinics in implement-ing these trials at a high level of quality and in line with all the standards involved. The KKS provides support in planning, implementing and evaluating clinical trials. The specific work processes at the KKS are very varied. For example, its staff are responsible for arranging contacts to study sites, industrial partners and experts, providing support in preparing and financing trials, or producing trial protocols and CRF.
Biometric consulting is also one of the fields of the KKS’ activities, as is the production of SOP for the implementation of trials and support for trial management as relief for trainee doctors. In connection with clinical trials, the KKS’ medical specialists assume responsibility for monitoring in line with GCP directives and SOP, report and process secondary effects and administer central test samples. Archiving is followed by statistical evalua-tion and reporting. The KKS’ staff prepare contracts and publications and are involved in analysing literature on a supportive basis and in meta-analyses.
Other work relates to further training for examining doctors, academic assistants, monitors and rotation doctors, lectures, seminars and workshops on the subject of “Clinical Trials”, the provision of methodological know-how from different disciplines and the organisation and production of expertises.
The KKS features six working groups and has a staff of about 20 who have gained particularly extensive experience in biometry and computer-based support for clinical trials.
The KKS has a modern computer network and professional software which can be used to support all aspects of trials. The KKS has gained specific experience in connection with oncological and surgical trials and trials on care research.
Within the context of an external audit commissioned by the Federal Ministry of Edu-cation and Research, the KKS has been certified as being capable of performing clinical trials in line with GCP. The KKS cooperates with the Working Group of Co-ordination Centres for Clinical Trials in Germany and is involved in numerous regional, national and international clinical trials and research projects.
Research and Teaching
The KKS’ research focuses on the provision of computer-based support for clinical trials, meta-analyses and innovative concepts for monitoring and audits. Assuming lead management on behalf of the Federal Republic of Germany, the KKS’ staff evaluate software solutions for clinical trials and support their implementation.
In this sector, the KKS provides consulting for the telematics platform of medical research networks in Germany.
In cooperation with foreign working groups, the KKS performs systematic reviews and meta-analyses on different topics. The Düsseldorf KKS regularly offers further training for qualification as academic assistant and examining doctor. The KKS also organises workshops on specific issues (for example in-surances in clinical trials and women in clinical trials) and regularly holds a “Clinical Trials” colloquium.