Today, many seriously ill cancer patients do not have satisfactory standard treatment options. A great part of these patients wish to be enrolled in clinical phase I and early phase II trials to gain access to new investigational therapies. In the Nordic countries, however, the number of these trials are limited. It is important to ensure the access to new investigational therapies. Patient recruitment is critical to the drug development program and pharmaceutical companies often choose tertiary oncologic centres with larger patient populations for initiating such trials.
The network is designed to ensure patient access to new investigational drugs and to allow customer information and easy access to phase I and early phase II programs in the Nordic countries.
The network was founded in March 2011 and is based on a collaboration between Clinical Cancer Research Unit, Department of Oncology, Oslo University Hospital, Norway; The Phase I Unit, Department of Oncology, Rigshospitalet, Copenhagen, Denmark; Center for Cancer Research, Department of Oncology, Herlev Hospital, Copenhagen, Denmark; Clinical Trial Unit, Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland; Early Clinical Trial Unit, Department of Oncology, Karolinska University Hospital, Stockholm, Sweden. Clinical Trial Unit, Haukeland University Hospital, Bergen, Norway and Clinical Trial Unit, Aarhus University Hospital, Denmark attended the collaboration in 2013 and 2014.
The departments included have all been involved in drug development for many years. Thus, all departments have considerable experience and reputation for scientific and medical expertise.
Denmark aims to be a world-class preferred country for early clinical testing of new drugs in patients. It is therefore essential for early clinical trials to be conducted with a high degree of quality, predictability and competiveness. This requires (1) that the early clinical testing is conducted in clinical settings specialised in early phase trials which can also offer world-class medical expertise within the diseases in question; (2) that a national recruitment strategy se-cures the desired number of relevant patients within a short timeframe; and (3) that all ad-ministrative and regulatory processes facilitate fast and simple initiation of new trials.
NEXT has the potential to offer an easy one-stop-shop opportunity for the industry as well as for hospital researchers and to provide smooth and easy access to the country’s strongest ear-ly phase-experienced clinical research environments and to key opinion leaders as well as op-timised administrative and regulatory processes.
NEXT also has the potential to develop a national patient recruitment strategy as it is a priority of clinical NEXT partners jointly to provide national database platforms to support such re-cruitment. Furthermore, it is the intention to add patient-specific data to the recruitment pro-cess to support a precision medicine-approach, i.e. selection of subgroups of patients for specific trials.
BRIC is a centre of excellence for biomedical research. The scientists in the centre focus on understanding the molecular mechanisms leading to various diseases, including cancer, CNS-related diseases and metabolic diseases
The research at the Finsen Laboratory is focused on proteolytic mechanisms in cancer invasion and metastasis. Several of the molecules involved in matrix degradation are revealed to be strong prognostic markers in various types of cancer and the Department of Oncology is involved in these studies. The Finsen Laboratory is situated in the Biotech Research and Innovation Centre, close to the hospital.
The Department of Radiation Biology is a cancer research laboratory within the Oncology Clinic at the Finsen Centre, and part of The Copenhagen Cell Biology and Cancer Research network (The CCC Network Project) within the Faculty of Medicine, University of Copenhagen, (www.ku.dk). The general intend of the laboratory is to study molecular and phenotypic features of Lung Cancer and Brain Tumors.
Above all, growth factor receptor studies are of interest. The primary aim is to generate more insight into the influence of these growth factors on the malignant phenotype of cancer cells, and the secondary aim is to extend that knowledge to patient material in terms of testing possible new diagnostic and prognostic tools, as well as suggesting new translational treatment modalities viz. targeting therapy and inhibition of signal transduction.
All patients referred to the Phase 1 Unit at Rigshospitalet are offered biopsies for DNA deep exome-sequencing and RNA sequencing for expression profiling for allocation to appropriate trials. This is performed in collaboration with molecular biologist at Center for Genomic Medicine, as well as specialists in bioinformatics, clinical genetics, and pathologists.