Coordination Center for Clinical Trials

Emphases

  • Key work areas

    • Planning, implementation and evaluation of clinical studies
  • Key research areas

    • Computer-based support for clinical studies
    • Systematic reviews and meta-analyses
    • Monitoring / audit concepts

The Coordination Centre for Clinical Studies (KKS) is a central element of the Faculty of Medicine at Düsseldorf’s Heinrich Heine University. The KKS supports clinical, primarily multi-centre studies taking into consideration Good Clinical Practice (GCP) and academic criteria, relating to both admission-relevant studies and exclusively academically focused studies.

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 studies, 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 studies 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 studies, the Federal German Ministry of Education and Research has established structures which are intended to improve the quality of clinical studies 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 studies 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 studies entails a better level of care for the patient.

The KKS supports all aspects of clinical studies and assists the clinics in implement-ing these studies at a high level of quality and in line with all the standards involved. The KKS provides support in planning, implementing and evaluating clinical studies. The specific work processes at the KKS are very varied. For example, its staff are responsible for arranging contacts to study centres, industrial partners and experts, providing support in preparing and financing studies, or producing study 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 studies and support for study management as relief for trainee doctors. In connection with studies, 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 Studies”, 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 studies.

The KKS has a modern computer network and professional software which can be used to support all aspects of studies. The KKS has gained specific experience in connection with oncological and surgical studies and studies 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 studies in line with GCP. The KKS cooperates with the Working Group of Co-ordination Centres for Clinical Studies in Germany and is involved in numerous regional, national and international clinical studies and research projects.

Research and Teaching

The KKS’ research focuses on the provision of computer-based support for clinical studies, 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 studies 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 studies and women in clinical studies) and regularly holds a “Clinical Studies” colloquium.

Contact


Bild von:   Henrike Kolbe
Henrike Kolbe
Sponsorbeauftragte, Qualitätsmanagementbeauftragte
Berufsbezeichnung
Dipl. - Chemikerin
Straße
Moorenstraße 5
Ort
40225 Düsseldorf
Tel.2: 
+49(0)211/81-19701
Fax: 
+49(0)211/81-19702

Further information

Visit us at www.uniklinik-duesseldorf.de/kks.

 
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  • Zuletzt aktualisiert am 16.01.2017
  • Current URL: http//www.uniklinik-duesseldorf.de/en/unternehmen/institute/coordination-center-for-clinical-trials/