Norwegians Join Forces to Keep Clinical Trials

When Eastern Europe offers low cost trials and Asia huge populations, the Nordic region needs to push its unique high-quality factors to compete.

(On the picture: Oslo Cancer Cluster’s Foresight group for oncological clinical studies. Photo: Vidar Sandnes)

The Nordic countries have very good healthcare systems on all levels, providing equal service to all patients. They also have cancer registries that include every case dating back 50 years and a positive attitude towards clinical research among the population. The fact that the Nordic countries have similar languages and treatment philosophies is of course a huge advantage for cooperation between the countries.

Clinical studies are of significant importance for securing patients access to new and innovative treatments, as well as providing clinicians first-hand competence on new products and methods. They also ensure that the Nordic countries can offer the industry competitive and attractive clinical trials of new products.

Losing phase I and phase II trials would not only cause delay in the access to new drugs for Scandinavian patients, but also missed opportunities for important translational research in all the Nordic countries. Today’s situation, with small populations spread over five countries that all require separate trial approvals, is just not an option.

Nordic network for early cancer trials
There is a strong commitment among the Nordic countries to build on a common Nordic platform for clinical cancer trials. In 2011, the Nordic Network for Early Cancer Trials (Nordic NECT) was launched by Norway, Sweden, Denmark and Finland. A total of 67 clinical trials have been registered by the countries since its inception and are presented on the joint website:www.nordicnect.org. In November the Norwegian Cancer Society announced they will support Nordic NECT with NOK 150.000 (EUR 20.000) annually for three years.

 “This grant allows us to take the necessary step towards creating a ‘one stop shop’ for clinical trials in the Nordic area and developing a simple system for cross-border referral of patients for experimental treatments” says Professor Steinar Aamdal from Radiumhospitalet, Oslo University Hospital, who heads Nordic NECT. Radiumhospitalet at Oslo University Hospital is Northern Europe’s largest comprehensive cancer centre.

Determined to boost clinical studies in oncology
The Norwegian member organisation Oslo Cancer Cluster has one of the world’s largest pipelines of innovative cancer drugs and is in the process of concluding a foresight process that investigates how oncological clinical studies in Norway can be strengthened. A strategy group, made up of representatives from all Oslo Cancer Cluster member groups, public authorities and key clinical studies, has been asked to make a comprehensive, long-term assessment of what needs to be done. The group has, among other issues, discussed ways to improve cooperation between hospitals and the industry.

“I am relieved and encouraged by the fact that we all seem to see eye to eye on the main challenges facing Norwegian oncological studies, even though we come from different backgrounds,” says Tone Skår, Coordinator of Clinical Research at Innovest in Bergen.”Conducting clinical studies is not a luxury. It should be recognised as an intrinsic and critical part of high-quality cancer treatment.”

Another participant, Thorbjørn Halvorsen, observes: ”We need to find a common voice. I hope the process will help us to persuade politicians and senior management at hospitals that boosting clinical research is an urgent matter!”. Halvorsen is Head of Clinical Research at Roche Norway, as well as Chairman of LMI’s Committee for Clinical Studies (The Association of the Pharmaceutical Industry in Norway – LMI).

A report summarising findings and recommendations will be drawn up following the final workshop in December and followed up by the board of Oslo Cancer Cluster in 2013.

National program for stratified medicine
Norway has a National Cancer Registry dating back to 1952, a single main health service provider, and equal access to health care services. This combination provides Norway with a unique opportunity to realize a nationwide initiative to build an infrastructure for molecular diagnostics representing the whole population. To start on such a database and a pilot for national diagnostic routines, the Norwegian Cancer Genomics Consortium was established in 2011 and the National Program for Stratified Cancer Medicine kicked off at the beginning of 2012. The interdisciplinary consortium consists of Oslo Cancer Cluster and cancer research centres in all the health regions and university hospitals in Norway.

The consortium has so far received a total of NOK 75 million (EUR 10 million) from the Norwegian Research Council, and a first clinical research project has been initiated to identify all gene changes in 800 Norwegians with different types of cancer. Larger and more specific studies are in the planning stages. The long-term goal of this new initiative is to offer Norwegian patients better service when it comes to cancer treatment and diagnostics. The project will also be able to offer genomics support for clinical trials in Norway.

“This project has enormous potential for the research and development of new cancer treatment strategies,” says Professor Ola Myklebost from Oslo University Hospital, who heads the Consortium. “The model has already attracted considerable international attention.”

An article published in Nature on 10 July 2012 stated: “If successful, the consortium could become the world’s first nationwide initiative to sequence tumours and healthy tissue from every cancer patient.”

Oslo Cancer Cluster
Oslo Cancer Cluster is an oncology research cluster and a non-profit member organisation, with members from the whole oncology value chain, also outside of Norway, dedicated to improve the lives of cancer patients by accelerating the development of new cancer treatments. Oslo Cancer Cluster was established in 2006 and is one of Norway’s twelve Norwegian Centres of Expertise.
www.oslocancercluster.no

NORDIC NECT – the Nordic Network for Early Cancer Trials
The network is designed to ensure patient access to new investigational cancer drugs and to allow customer information and easy access to phase I and early phase II programs in the Nordic countries.
www.nordicnect.org

Norwegian Cancer Genomics Consortium: National Program for stratified medicine
A national research collaboration in Norway to determine the utility of next generation sequencing across different tumour types for a high-resolution cancer diagnostic platform within the Norwegian health service, with the objective to obtain population-wide coverage and clinical implementation.
www.cancergenomics.no