The Department of Oncology, Herlev Hospital, University of Copenhagen
The Department of Oncology has been involved in clinical trials for more than 25 years. The department has a broad experience with cytostatic drugs, biological and anti-hormonal agents, dendritic cells and intrahepatic chemotherapy.
The Department is focused on research and has approximately 65 actively recruiting studies as well as approximately 65 ongoing trials with patients in follow up. This requires expertise and resources in several areas which are handled by different Units that cooperate seamlessly within the Department of Oncology. These Units are presented below.
Centre of Cancer Research
Centre of Cancer Research consists of two subunits, "The Clinical Research Unit
" (KFE), founded in 1992, and " Cancer Treatment, Clinic 5 (the former Experimental Cancer Therapy Unit
" founded in 2004. The core competence focuses on the planning, preparation and conduct of phase I and early phase II clinical trials in cancer patients as well as phase II and III trials. The centre has a high recruitment rate due to a focused screening procedure and dedicated screening staff.
- has all necessary facilities available for performing quality clinical trials, including first-in-man and GMO studies (inspected by the Authorities 2012)
- offers complete project and clinical trial management systems including statistical
- operates with ICH-GCP to standards of the pharmaceutical industry, including standard operating procedures (SOPs) covering all aspects of clinical trials
- complies with all current legal requirements and the EU Directive on Clinical Trials (EU Directive on Clinical Trials (Directive 2001/20/EC & Directive 2005/28/EF)
- has experience in design and administration of databases and the development of computerised trial management software including eCRFs (OpenClinica) and randomization
- has experience in incorporation of health economics and quality of life measures
- has expertise and computing facilities required to co-ordinate multicentre clinical trials
- organises educational activities, including training courses and workshops
- has a network of leading scientists and oncologists, including collaboration with other phase I units in Denmark and Europe
- is a member of EORTC, NEXT Oncology and Nordic Nect trial cooperation.
Cancer Treatment, Clinic 5 combine an outpatient clinic with a care unit with facilities for close patient surveillance, including equipment for continuous cardiac monitoring. The Unit has 8 beds, 4-6 treatment chairs and three outpatient consulting rooms. In cooperation with our inpatient ward we cover seven days a week.
Professor, DMSc Dorte Nielsen and Senior physician are responsible for most phase I-II early clinical trials.
The dedicated team includes 10 nurses and 2 secretaries.
All staff members are experienced, GCP trained and trained in emergency situations. The Unit has close co-operation with the critical care unit and have 24-hour access to the hospital emergency response team.
Resources - The Clinical Research Unit
PET and NMR functional imaging
There is a close cooperation with the PET and Cyclotrone Unit at the hospital. This unit is equipped with 3 PET-CT scanners (2 Siemens and 1 Philips) and a Cyclotrone. By the end of this year 1-2 more scanners will be available. In addition, we have access to MRI (1.5 and 3 tesla), 64 (Philips Brilliance) and 128 (Siemens Somatom Definition Flash) slice CT scans, dynamic CT, ultrasound Doppler with colour contrast enhancement and a variety of other interventional diagnostic radiology and clinical physiological assessments. A group of senior technicians and radiologist are dedicated to the clinical studies, and the quality is ensured by a close cooperation and coordination.
Molecular and biochemical analyses
The following analyses can be performed at Department of Pathology and Department of Clinical Chemistry: