Strategic implementation projects 2016

In 2016 the following additional projects received funding up to 500 000 NOK.

Workshop on cross-border participation in clinical trials

Oslo University Hospital – Radiumhospitalet

Project leader: Steinar Aamdal

Clinical trials in cancer are typically performed in small patient populations with specific, often rare, mutations. Recruiting sufficient number of patients for such trials in each Nordic country is challenging and sometimes almost impossible. Recruiting patients from the whole Nordic population however carry great potentials and makes the region attractive for clinical trials and drug development. Recruiting patients to trials in another country, cross border, has however proven to be difficult.

The aim of this workshop is to bring the different stakeholders to the same table to identify and address the obstacles preventing cross border participation in clinical trials in the Nordic region. Working groups will be established which in greater detail will address the different problems.

 

Harmonised Nordic Ethical Evaluation of Clinical Trials

Hospital District of Southwest Finland

Project Leader Mika Scheinin

The project aims to foster Nordic collaboration and competitiveness in clinical trials by developing harmonised Nordic procedures for the ethical assessment of clinical trials. The deliverables expected from the project include

•        mapping of current national best ethics committee practices and available document templates in the Nordic countries;

•        a Nordic seminar aiming at establishing recommendations for common operating procedures and guidance documents for Nordic ethics committees;

•        recommendations for common templates to be published by the ethics committees for the purpose of guiding investigators and sponsors in the application process (including an analysis of possibilities to use identical/similar electronic handling tools in the Nordic countries, in addition to the common framework provided by the electronic portal of the European Medicines Agency);

•        recommendations for the establishment of a joint Nordic body to coordinate and harmonise the ethical review of clinical trials in the Nordic countries; and

•        a project report that will serve all involved parties as a source of information on the ethical review process of clinical trials in the Nordic countries.

 

Nordic Conference on Real-World Data

Pharma Industry Finland

Project Leader Mia Bengtström

The aim of the conference is to show the possibilities existing, remarkable examples of research and initiatives in the Nordic countries for the pharmaceutical companies and inspire the countries in the Nordic region to find common best practices. Focus is put to explore the Nordic goldmine of clinical, register and biobank data that can be utilized in research. The aim is also to boost collaboration between pharma and academia and between the Nordic countries. A conference is an excellent opportunity to attract high level speakers, and getting the attention of Pharma decision makers in order to attract investment to the region.

The conference will be arranged 29-30 November 2016 as a one and a half day conference starting with lunch on 29.11, followed by key note speakers from academia and industry. Day 2 will be a full day conference with a lot of interesting examples from all Nordic countries. The conference dates are chosen so that participants will have to opportunity to attend Slush http://www.slush.org / Digital Health section on Dec 1, 2016, if they chose to do so.

 

Establishing a Nordic Network for Clinical Trials in Children – stage 2

Clinical Research Institute HUCH

Project Leader Pirkko Lepola

Children need better access to safe and effective medicines addressing their therapeutic needs. Due to this demand, the European Union a special Paediatric Regulation (Regulation (EC) no 1901/2006) came into force in 2007. The effect of the Regulation will be seen in the near future, as the forthcoming trials require urgently new trial sites, investigators and patients. Currently, over 1 000 new Paediatric Investigation Plans (PIP) has been agreed by the European Medicines Agency (EMA), leading to the recruitment need for more than 500 000 children in Europe over the next 5 years.

A Finnish network FINPEDMED (Finnish Investigators Network for Pediatric Medicines) was established in 2007. In Norway, the Medicines for Children Research Network (NorPedMed) was established in 2013. With funding from the Nordforsk Nordic Trial Alliance – NordicPedMed –project (Stage I) in 2014-2015, it was possible to initiate the development of National paediatric clinical networks also in Denmark, Iceland and Sweden. That project concluded that a Nordic network of these National networks is feasible, and developed feasibility plan with Organizational Principles and rationale for NordicPedMed. A Nordic network of national networks, will be more competitive and more attractive than National networks separately, by having a larger population for the recruitment base (5.4 million children), and more comparable to Networks of the large European countries. This gives Nordic countries more leverage both within the Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency) and in discussions with the industry.

In the very near future, there are several new paediatric clinical trial infrastructure initiatives about to start in Europe. All these initiatives aim at building European infrastructure with interoperable processes for paediatric clinical trials. These initiatives create opportunities for significant funding available and under consideration, which alongside provide the funding necessary to develop NordicPedMed clinical trial sites to high professional standards. However, full participation in these project consortiums requires that a network has Enpr-EMA Category I network status or comparable. Currently only FINPEDMED fills this requirement.

The second development phase (Stage II) of NordicPedMed is «Establishing a Nordic Network for Clinical Trials in Children». This includes a rapid building of governance and management infrastructure for NordicPedMed. The official governance and management will allow NordicPedMed to apply Enpr-EMA membership and participate in the infrastructure consortiums, opening new possibilities for other Nordic national networks to join the European paediatric clinical trials infrastructure in the most flexible way once they reach the organisational maturity needed. For full operations, NordicPedMed will also develop common IT-structure, including a common investigator´s registry, employing existing FinPedMed IT- structure and operational model for Nordic investigators network for paediatric Clinical Trials.

Nordic Hotspot for Life Science

Karolinska Institutet

NTA working group

The previous/present project Nordic Trial Alliance, funded by the Nordic Council of Ministers and Nordforsk, revealed the need for a common Nordic research area. One of the findings reported was the possibility to create a global hotspot for discovery, development and supervision of products from Life Sciences. The Nordic area was considered to have unique qualities that on a Nordic scale could be combined into a “superzone”. This application aims at making a gap analysis and includes a closer look on what supportive collaboration that could be relevant, an inventory of knowledge needed and a report to the NTA Stakeholders in January 2017 on how such an idea could be further contextualised.

Nordic Monitoring Network -Network for Monitoring and Quality Assurance of Academic Studies in the Nordic Countries

Aarhus and Aalborg University Hospitals

Project Leader: Birgitte Vilsbøll Hansen

The aim of the Nordic Monitoring Network is to make the Nordic countries a more attractive place to conduct a clinical trial by branding the Nordic region. The network aims to offer a coordinated GCP-monitoring of academic multinational drug studies, which are being conducted in the Nordic countries and to increase the level of GCP-knowledge amongst academic researchers in the Nordic countries and thereby increase the quality of the drug research.

The network also aims to create a forum that can speak with one voice, when lobbying with regard to new legislation on drug trials etc. Among other things, the network will update an earlier map of all monitoring units that offer monitoring of academic drug trials in the Nordic countries. It will also work to improve and further develop a system of coordinated monitoring of multinational studies in the Nordic countries, adding a communication plan to the guidelines. The network will also share knowledge and experience (e.g. regarding course activities) at regular meetings twice a year.

Nordic network addressing the a antimicrobial resistance (AMR) challenge and mapping AMR-related research in the Nordic countries

Oslo University Hospital

TTA Consortium

The goal of the current application is to broaden and develop the Nordic networks, as a natural basis for further applications to EU/JPI-AMR, the public sector and NGOs. 

WP1: BASIC ASPECTS AND NOVEL DRUG TARGETS

WP1.1. Innovative therapeutics

We will develop and study effects of new drugs and examine the use of old and revived antibiotics. Novel screening methods for chemical libraries in search of new classes of antibiotics will be employed.

WP1.2. Novel barriers to horizontal gene transfer and evolution of resistance

We will focus mainly on transformation as an important mechanism for horizontal gene transfer (HGT) of antibiotic resistance genes between “contemporary” bacteria. Such antibiotic resistance is polygenic in nature and transposon-linked sequencing (Tn-seq) technology provides a unique methodology to identify genes that mediate AMR and can represent novel drug targets.

WP2 CLINICAL RESEARCH APPROACHES TO COMBAT AMR

WP2.1. Surveillance and clinical trials

 We will conduct surveillance projects for better detection and characterization of extended-spectrum beta-lactamases (ESBL) in Gram-negative bacteria. Active surveillance in all patients will contribute to a more efficient detection of ESBL-producing Enterobacteriaceae as well as other relevant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).

WP2.2 Novel infection control interventions

We will do a systematic characterization of the microbiota composition in selected patient groups and healthy controls at the genomic level, and follow development of acquisition or failure of eradication, infection and nosocomial transmission. Defining microbiota characteristics will allow interventions targeted at infection prevention in the individual patient (personalized medicine) and infection control at the hospital level.

THE NORDIC AMR RESEARCH NETWORK

All WPs will profit to include representatives from several Nordic countries when seeking other international collaborators, being a very attractive partner from a Nordic “stronghold niche” towards other "high-prevalent" European and global partners. The network will be established by invitation to 1-2 workshops. A call will be conveyed through relevant Nordic and national bodies including research councils, public health institutes, NGO’s ( REACT), existing informal networks etc. The workshops will be professionally facilitated, addressing networking and mapping of AMR scientists and their activities facilitating coordination. The outcome will be a new Nordic network addressing AMR, publicly available information on an interactive website and joint efforts to generate further funding for continued development of the network will be planned.

The Nordic Trial Alliance (NTA) is a three-year pilot project running from 2013 to 2016, funded by the Nordic Council of Ministers and NordForsk.