The Clinical Trial Unit at Haukeland University Hospital consists of a section for adults and a section for children. The unit is organised in the Department of Research & Development, but closely linked to the Department of Paediatrics as well as to several major clinical departments in the university hospital. Haukeland University Hospital has built new infrastructure and made it possible to participate in both national and international clinical trials of children and adults.
Clinical trial unit for adults
The clinical trial unit for adults is located in the hospital’s main building, one floor over the intensive care unit and the hospitals intervention centres, radiology services and operating theatres. The clinical research unit has a formal service agreement with these clinical departments for support when unexpected clinical situations arise.
The trial unit has three intensive care standard beds and five out-patient places, and a high quality laboratory facility for handling of chemical and biological material including living cells. The main hospital building is connected to the Laboratory building and the Preclinical Research Building, providing state-of-the-art instrumentation and technology platform for animal research
, medical visualization
and molecular imaging
. This arises from an extensice collaboration with The University of Bergen. In addition, the trial unit has close close collaboration with our ISO-certified clinical laboratory and a well-equipped radiology department providing technology for functional MRI and CT-PET.
The clinical trial unit for adults was initiated in November 2006 as part of the university hospital’s commitment to facilitate research activities with high demands for safety and quality. The clinical trial unit aims to be a contributor in the transfer of research from basic research in technologies and drugs to trials in adults.
Clinical trial unit for children
The paediatric trial unit is located in the Department of Paediatrics at Haukeland University Hospital, and has premises both in the bed ward and in the out-patient unit. Proximity to the clinical specialist and highly competent co-workers ensures that clinical studies in children can be carried out in safe surroundings with high security for the children recruited to clinical trials.
New drugs have, up to now, mainly been tested in adult subjects and great parts of medical treatment of children have not been based on controlled clinical trials in children. This is most unfortunate, since children should not to be viewed as small adults, but often has different distribution, decomposition and excretion of some important drugs compared to adults. Recently the European Medicines Agency (EMA) demands that all new drugs that also are intended for children must be tested in children. To our best knowledge we believe this unit is the only one of its kind in the Nordic countries. The clinical trial unit for children perform an increasingly number of clinical trials after it was established in March 2007.
The clinical trial unit gives priority to studies of human pharmacotherapy in early phases conducted by researchers with connection to the university hospital or the university. The unit also conducts clinical trials for external clients, and in particular pharmaceutical industry. The research co-ordinators are highly motivated and experienced special nurses with intensive care, oncology and paediatric background. Sample and patient handling and logistics together with CRF support is our main focus together with training of other personnel in Good Clinical Practice and support in study planning and application preparation to local ethical committee and Norwegian Medicines Agency. Our CTU is affiliated to European clinical infrastructure networks (NorCRIN, EATRIS) as well as national networks (Oslo Cancer Cluster).
The clinical trial unit receives inquiries from researchers who need help in all phases of clinical trials and provide consulting on the design of the protocol, applications to the pharmaceutical company, application to the Ethics Committee, Norwegian Medicines Agency and the Civil Ombudsman and a direct contribution to the completion of selected studies.
28.02.2012 13:07 |