Competence for
Clinical Research

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IZKS Mainz

IZKS (Interdisciplinary Centre for Clinical Trials, German abb.: IZKS) is a professional academic clinical trial organisation at the University Medical Centre (UMC) Mainz. IZKS connects clinical trial activities in clinical trial units with non-clinical and methodological study activities. Success and achievements have been judged as very good in several evaluations reflecting high level of quality and efficiency of tasks taken over in clinical trials by IZKS.

Interdisciplinary Centre for Clinical Trials Mainz (IZKS)

1999 the University of Mainz started to develop a central clinical trial organisation by establishing the Coordinating Centre for Clinical Trials. Growing expertise and supply of services as well as increasing recognition led to the implementation and development of IZKS in 2007.

IZKS is funded by German Federal Ministry of Education and Research (BMBF) for continuous optimisation of multicentre clinical trials, for building regional trial networks and for improving qualification of study personnel. IZKS has established cooperations with academic and non-academic hospitals, private physicians, study groups, paediatric network (PAED-Net), surgical network (CHIR-Net), competence networks in medicine and with pharmaceutical and medical device industry. Success and achievements have been assessed repeatedly resulting in excellent appraisals and subsequently in funding extension and many new grants for research projects. In addition, quality and efficiency have been audited several times and GCP adherence has been confirmed by an inspection of the local authority. 70 trained and experienced medical, scientific and technical employees contribute to planning, conduct, evaluation and publication of clinical trials.

Extensive training programmes have been established for internal and external study staff.

Core Competences

Haupteingang der Universitätsmedizin Mainz

IZKS is successfully coordinating clinical and methodological study activities for more than four years now.
Full scope of clinical research according to ICH-GCP has been implemented with focus on conception, planning, conduct and analysis of innovative clinical trials investigating drugs, medical devices and other interventions, e.g. psychotherapeutic and surgical procedures.
IZKS offers efficient and quality-oriented conduct of clinical trials in 17 professional clinical trial units: Anaesthesia, Cardiology, Dermatology, Gynaecology, Gastroenterology, Hepatology/ Infectiology, Immunology/Haematology, Mental Disorders, Neurology, Oncology, Ophthalmology, Paediatrics, Pulmonology, Radiology and Rheumatology which provide a broad spectrum of methods and patients in 26 disease areas. IZKS is covering full service according to the requirements concerning sponsor responsibility in clinical trials, i.e.


  • Project management/trial co-ordination
  • Writing of essential trial documents, e.g. study protocol and study report
  • Quality management
  • Regulatory Affairs including Trial Master File maintenance and compilation
  • Monitoring
  • Biostatistics, statistical programming and Data Management
  • Information technology including Electronic Data Capture System (EDC), web-based randomisation, registries for health care research and homepages for research projects
  • Safety management for drug and medical device trials including SUSAR reporting and regular Safety Reports (DSURs)

Study Cooperations Increase Efficiency and Competence

IZKS is a partner of several German and European cooperations: IZKS is not only the regional trial centre of CHIR-Net but also a member of the competence network ‘Diabetes’ funded by German Federal Ministry of Education and Research (BMBF) and the Research Association ‘Musculoskeletal Diseases’ (Forschungsgemeinschaft Mukoviszidose e.V.). Additionally, IZKS is a partner of the Central European Society for Anticancer Drug Research (CESAR), the German Research Community for Cystic Fibrosis (German abb.: FGM) and the German Foundation for Organ Transplantation (German abb.: DSO).

Nationally and internationally, IZKS cooperates with trial centres of eighteen universities in Germany and five in other European countries as well as with universities and enterprises in the US.

Qualification of Clinical Research Personnel

IZKS offers certified courses and seminars for the qualification of scientific and non-scientific clinical research personnel. Furthermore inhouse-trainings and specific courses for various societies are performed as well as expert panels for clinical trials with medical devices.

The director of IZKS is authorized to train, educate and examine MDs who are aiming to acquire a board certification in clinical pharmacology.

Publications in 2011

  • Tadic A, Wagner S, Gorbulev S , Dahmen N, Hiemke Ch, Braus DF, Lieb K. Peripheral blood and neuropsychological markers for the onset of action of antidepressant drugs in patients with Major Depressive Disorder. BMC Psychiatry 2011, 11:16
  • Paschold M, Schröder M, Kauff DW, Gorbauch T , Herzer M, Lang H, Kneist W. Virtual reality laparoscopy: which potential trainee starts with a higher proficiency level? Int J CARS 2011; 6 (5): 653-662
  • Möhler M, Mueller A, Hartmann JT, Ebert MP, Al-Batran SE, Reimer P, Weihrauch M, Lordick F, Trarbach T, Biesterfeld S, Kabisch M , Wachtlin D , Galle PR, the German Arbeitsgemeinschaft Internistische Onkologie (AIO). An open-label, multicentre biomarker-oriented AIO phase II trial of sunitinib for patients with chemo-refractory advanced gastric cancer. Eur J Cancer 2011; 47: 1511-1520 [Published Online: 9 May 2011]
  • Roeder F, Wachtlin D , Schulze R. Necessity of 3D visualization for the removal of lower wisdom teeth: required sample size to prove non-inferiority of panoramic radiography compared to CBCT. Clin Oral Invest 2011; Published online: 26 April 2011; DOI 10.1007/s00784-011-0553-8
  • Wiltink J, Ruckes C , Haselbacher A, Canterino M, Leichsenring F, Joraschky P, Leweke F, Pohlmann K, Beutel ME. Transfer of manualized Short Term Psychodynamic Psychotherapy (STPP) for social phobia nto clinical practice: study protocol for a cluster-randomised controlled trial. Trials 2011; 12:142
  • Kabisch M, Ruckes C, Seibert-Grafe M , Blettner M: Randomisierte kontrollierte Studien: Teil 17 der Serie zur Bewertung wissenschaftlicher Publikationen. Dtsch Arztebl Int 2011; 108(39): 663–8. DOI: 10.3238/arztebl.2011.0663 (Impact-Faktor: 2,108 [Journal Citation Report 2010])

Contact

Interdisziplinäres Zentrum Klinische Studien (IZKS) Universitätsmedizin Mainz

Gebäude 508
Langenbeckstr. 1
55131 Mainz

Phone: 06131 17 99 13
Fax: 06131 17 99 14
office@izks-unimedizin-mainz.de

http://www.izks-mainz.de


Facts

about the IZKS Mainz

  • Director
    Christian Ruckes, Dipl.-Math.
  • Foundation
    1999 by the Medical Faculty
  • Funding
    of the Coordinating Centre for Clinical Trials
    German Federal Ministry of Education and Research from 1999 to 2005
    Funding of the IZKS
    German Federal Ministry of Education and Research from 2007 to 2015
  • Member of the KKS-Network
    Since 1999, founding member
  • Staff development
    3 members of staff in 1999
    68 members of staff in 2011
  • Main focus
    Paediatrics, surgery, psychiatry and und psychotherapy, oncology, neurology, cardiology, clinical pharmacology, clinical trials with medicinal products
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