Centres for Clinical Studies

Call for proposals:	2006
Funding period:	2007 - 2015
Funding volume:	45 mio EUR
Number of projects:	6

 

Centre for Clinical Studies Leipzig

The aim of this application is to enhance clinical trial activities already present in Leipzig and to extend these activities by adding new competences. Other than the existing KKSL (Coordination Centre for Clinical Trials Leipzig) there will be founded a Site Management Organisation (SMO) and together with a number of other trial focussed institutions in Leipzig these two facilities will be integrated to form the Clinical Trial Centre Leipzig (KSL Leipzig).

The centre will consist of four modules:
- patient recruitment, establishment of an additional central KSL-site management organisation (KSL-SMO);
- methods, genetics and statistics as well as integrated IT-solutions for optimisation of patient recruitment and/or clinical trial implementation;
- initiation of a new master study path (“Clinical Research and Translational Medicine”);
- incorporation of associated organisations with clinical trial related activities.

Offered will be comprehensive solutions for the implementation of complex clinical trials including concomitant molecular and /or genetic side projects in scientific networks. These complex trial designs require a professional organisation as well as a well-established quality control to comply with legal and regulatory requirements. In addition to this the SMO will be concentrated on patient recruitment and offers on-site support in performing clinical trials with well trained study nurses and study coordinators. With several local trial units in the University Hospital Leipzig and its university teaching hospitals the SMO will be able to recruit a lot of patients in a short time. With the strategy the management and monitoring of clinical trials becomes easier for contractual and cooperation partners.

Centre for Clinical Studies Mainz

A professional infrastructure bringing together clinical medicine, science, methodology, operational management and providing all operational, methodological and regulatory tasks as well as professional study sites with informed patients and well trained personnel are necessary to successfully conduct clinical trials with high data quality in an exceedingly competitive environment.

Therefore, the University of Mainz, Medical Centre will establish an Interdisciplinary Centre for Clinical Trials (IZKS), in which clinical scientists and study personnel can closely work together under one roof. The IZKS will be funded by the German Ministry of Education and Research (BMBF). Existing study structures including the BMBF funded pediatric and surgical study centers as ell as the Coordination Centre for Clinical Trials (KKS) will be integrated. Regional and disease-specific networking is a further step in improvement conduct of clinical trials.

Subsequently, the main objectives of IZKS are
- building up new clinical study centres in three departments of the University Hospital Mainz (neurology, psychiatrics, anesthesiology/radio-diagnostics)
- conduct of scientific non-commercial and commercial clinical trials according to GCP in diseases represented in the above mentioned clinical disciplines as well as in conservative and surgical oncology, psychosomatic diseases, infectious diseases, preventive and internal medicine
- evaluation of basic research findings concerning their clinical effects and benefit for patients
- optimization of trial methods (biostatistics, data management, IT-procedures), pharmacovigilance, trial medication, operational and logistical processes including administrative processes (contracts, budgets, staff management) as well as business development
- transfer of results in clinical care by rapid publications

IZKS will support initiation and optimization of clinical trials in Germany, innovation in research and clinical medicine and will establish long-term private public-partnerships with models for knowledge transfer. It is the purpose of this initiative to improve clinical research in Germany.

Centre for Clinical Studies München

The Munich Study Center (MSZ) has been the central coordinating unit for clinical studies conducted in the Medical Faculty of Technical University Munich for several years. Its primary objective has been to promote and to efficiently support the design, conduction, and analysis of investigator-initiated trials and also of trials for industrial sponsors (phases II-IV, mono- and multicentric). A high degree of quality and accordance with international guidelines has been ensured by the center, and support has been provided to all medical departments of MRI that have been involved in clinical trials. The center’s extension is focussing on a significant improvement and strengthening of clinical (patient-oriented) research in the Munich region. To achieve this, the following activities are planned.

- Central management of clinical trials (Central trial management and scientific support): Essential aspects are further improvement of quality management and quality control including monitoring of scientific clinical trials. To achieve this, Standard Operating Procedures (SOPs) and quality management have to be extended in order to guarantee compliance with international standards. Moreover, the AMG amendment of 2004 requested arrangements for sponsorship of investigator initiated studies which have been worked out together with the faculty and the legal department. For methodical and scientific support in biometry and informatics, a cooperation unit between MSZ and IMSE will be established. In addition a collaboration with the Ludwig Maximilian University of Munich (LMU) is planned in this field.

- Education and advanced training for clinical studies: Central aspects are an intensive educational program for study nurses and a new educational concept for study investigators based on the introduction of several rotating positions in combination with advanced training. Moreover, education in the region of Munich will be extended in cooperation with the IMSE and the LMU. The aim is to implement a concept for continuing professional education in this field.

- Clinical study units / study staff: To directly support clinical trials on the level of clinical departments, several rotating positions for investigators are planned within the faculty. Another pooled structure will allow for the provision of study nurses for all clinical departments. By this, a high standard of quality can be ensured uniformly.

- Study Networks and intensified cooperation with industry: In the past, local patient recruitment has been successfully improved in some medical areas by building regional study networks together with other hospitals and doctors’ practices. Based on these grounds, further study networks are planned to be founded and supported by a flexible study nurse pool. The MSZ will continue to act as the contact not only for sponsors, but also for pharmaceutical and medical technology industry. The relationship between the MSZ and the Munich biotechnology region will be strengthened to translate clinical innovations into new patient-oriented concepts more efficiently.

Centre for Clinical Studies Münster

The clinical trial centre optimizes the infrastructure as well as methodology of clinical trials at the interface of basic research and clinical practice. Also the clinical trial centre offers study-related staff capacities for clinical institutions, which assure qualified planning and conduction of all kind of clinical trials.

The units of the clinical trial centre - quality management, data management, SAE management and training - are centralized within the clinical trial center; activities within these areas will be assumed for all participating institutions of the medical faculty. For investigator-initiated trial (IIT) it will be obligatory to cooperate with the clinical trial centre, especially in the functional areas quality management and training.
To offer study-related staff capacities locally, 5 decentralized clinical trial subunits will be established. The staff of the decentralized subunits will support the scientific team concerning all aspects of on-site study management.

The clinical trial center will improve clinical studies regarding quantity as well as quality. Depending on additional staff capacities, these measures will increase the number of patients per study. Centralized quality management and accelerated recruitment of patients will also increase the number of studies and shorten the duration of clinical trials. Investigator initiated trials will profit extraordinary since the new infrastructure offers support during planning and conduction of clinical trials. All these measures advance translation of new concepts from bench to bedside.

Centre for Clinical Studies Köln

The Clinical Trials Centre (CTC) Cologne coordinates the clinical research of the Faculty. It consists of a central body, the KKSK, the clinical study offices including study coordinators and rotating physicians as well as a training academy for study personnel. Tutoring, a study register and a quality management coach guarantee consistent quality standards in the execution of the studies.

At start of the BMBF grant the KKSK merges with the new CTC, the study register is activated, and competitive posting for the seven new study office teams is initiated. A central pharmacovigilance ensures accurate assessment of adverse events and timely reaction. A close-knit controlling of the study administrative team ensures goal-oriented use of funds. The successful initiation of clinical studies assures ongoing effectiveness.

The study office teams will be able to continually refinance themselves through successful applications for future studies. The study register with give structure to the more than 200 expected parallel studies. The training and continuing education academy and quality managers guarantee the maintenance of high standards, even after the end of sponsorship. Cologne as an international study centre will be further strengthened.