The mission statement of the Drug Research Unit Ghent (D.R.U.G.) is to contribute to the development of new drugs by conducting clinical trials (Phase 0 – I – II) in compliance with international legislation and quality standards.
The department is headed by prof. dr. Sylvie Rottey. In 2015, D.R.U.G. merged with the Phase I Oncology Unit of the University Hospital Ghent.
Our scope is to conduct clinical trials in healthy volunteers and in (cancer) patients. Different types of clinical trials are performed, for example: first in human (Single dose and Multiple dose), Biomarker trials, Food/drug interaction studies. The majority of our sponsors is the pharmaceutical industry but also academic trials are executed.
We stand for high quality clinical trials. Our quality is garanteed by a quality control system (first party (internal) audits, training in procedures and
a close feedback on the spot). D.R.U.G. applied for NIAZ/Q-Mentum in the University Hospital Ghent and every year a GCP-audit is performed.
Inclusion of oncological patients is done on a multidisciplinary basis, which is reflected by the composition of the Phase I working group of the hospital. Moreover, half of the patients is referred from other hospitals. We are known by our colleagues by sending out a newsletter, by contact on a regular basis (phone & e-mail)
For inclusion of healthy volunteers in clinical trials D.R.U.G. has a healthy volunteer database with approximately 3000 active volunteers. More healthy volunteers are recruited by advertising in different magazines and papers. Material used for recruitement is all approved by the Etical Comité.
Recruitment healthy volunteers
D.R.U.G. searches on a continuous basis healthy volunteers. Every trial has its own in- and exclusion criteria. Volunteers can subscribe themselves via our website. Our website shows also a complete overview of the open trials. Everyone can participate in clinical trials, but not everyone can be considered as OK for a particular trial.
Volunteers who participate in clinical trials receive an attractive compensation. The compensation is based on the load of the clinical trial (for example: number of dose administrations, number of overnight stays in the unit…)
- Principal Investigator: Prof. Dr. S. Rottey
- Investigators (3): Dr. G. Van Lancker, Dr. B. Delafontaine and Dr. G. Schelfaut
- Medical Coordinator: Dr. G. Van Lancker
- Quality Coordinator: A. Coens
- Team leaders (3): E. Colman, C. Vandenabeele and K. Criel
- Clinical Research Coordinator (8)
- Trial Nurse (7)
- Administrative and Logistic Assistants (6)
- IT (1)
- Assistant Trial Nurses (16 bank personnel)