Clinical Trial Unit
At the DZIF, clinical-infectious studies of every phase and indication are conducted according to the highest standards.
New vaccines and medicines also need to be tested on humans on their tolerability and effectiveness before being launched. This is carried out in clinical studies (phases I to III). The DZIF has evolved to Germany´s top address for clinical research into infectious diseases. The DZIF has specialised clinical trial centres which are organised in the infrastructure “Clinical Trial Unit” (CTU). Twelve clinical trial centres currently collaborate under the umbrella of this network whose activities are centrally managed by the “Coordinating Office (CO)” in Cologne.
Developing a clinical trial is a multifaceted and time-consuming challenge—from choosing the appropriate study design and protocol writing to coordinating regulatory submissions and site management. In addition to providing the platform for clinical trial conduct within DZIF, supporting DZIF-scientists during clinical trial preparation is the CTU’s central mission. The CO of the CTU can be consulted any time during clinical trial development, but ideally as early as possible. Project-specific support includes clinical trial planning, site budgeting, approval procedures and site feasibility. In addition, the CO can facilitate opportunities for study personnel training, and supports during FlexFunds proposal development (e.g. feasibility and plausibility of study site budgeting).
The CO offers counseling and support to scientists on an informal ad hoc and as-needed basis. Areas of support include, but are not limited to:
- Clinical trial design, planning, set-up and local implementation
- Central site budget calculation and review
- Regulatory affairs and ethics committee submission
- Site selection management
- Counseling during FlexFunds proposal preparation
The working model of the DZIF-CTU has become a model for national and European networks within the EU-funded Innovative Medicines Initiative.
Since December 2017, the CTU has conducted its own multicentre observational study called DOPPIO (Duration of protection from pneumonia after pneumococcal vaccination in hemodialysis patients): The study investigated how dialysis patients respond to pneumococcal vaccination. The aim of the study is to improve individualised vaccination protection, as pneumococcal infection is one of the most frequent causes of death in this patient group. In 2022, the final report was submitted: 792 patients took part in the study. The final statistical analyses are currently being carried out.
