1. Stab forskning, innovasjon og utdanning 2016: MOVING FURTHER WITH MEDICAL TAILORING MAIN SESSION 2: Patient Involvement in the Nordic Countries Building a research program for patient inclusion Erlend B. Smeland Director research, innovation and education, Oslo University Hospital

2. Health research in Norway Strategic focus Increased resources Results –Increased number of articles –Increase in PhD theses –Increased citations Oslo University Hospital: 1260 man years in research 2015: 1905 articles

3. PhD theses in Norway, 2000-2012

4. Clinical research – relative citation

5. The Health&Care21 (HelseOmsorg21) The National Research and Innovation Strategy on Health and Care for the 21st Century was delivered to the Prime minister and the Minister of Health and Care Services June 2014. The Norwegian Government presented November 2015 the Action plan for implementation of the Health&Care21 strategy.

6. The 10 strategic initiatives of the Health&Care21 process are: Increased user involvement The health care industry as an industrial policy priority Knowledge mobilisation for the municipalities Health data as a national comparative advantage Improved clinical interventions Efficient and effective services Meeting global health challenges Increased, high-quality research and internationalisation Development of human resources Strategic and evidence-informed governance and management Stab forskning, innovasjon og utdanning

7. User involvement and description of research impact in health research User involvement required for health research financed by Ministry of Health and Care Services –Strategic fora –Evaluation committees –Projects –Evaluation Description of impact of research (applications) –Equal to quality (health research financed by Ministry of Health and Care Services)

8. Improve clinical research Politics More and larger clinical studies - across disciplines Increase number of patients participating in clinical studies Ensure equal acess to new efficient methods Clinical research of good quality which is useful for and used by the health services or the patients Actions Establish national program for clinical treatment research (multicenter studies) Restructured health research programs in RCN Strengthen infrastructure for clinical research –Nor-Crin established (national network) Stimulate international networks and funding

9. Industry-sponsored clinical trials are declining in Norway Oslo University Hospital Source: Siri Kolle, Inven2

10. Novel clinical studies OUS 2015 (Inven2) Type of studyClassification

11. Public funding of health research (% of GDP) Total funding of health research (% andel av GDP)

12. Clinical studies - issues Political aim to strengthen the possibilities for patients to participate (overview, information, financing) –Increase in multicenter studies Not a patient right Clinical studies NOT within the priorities of the health system (Lønning 1&2) Not equally distributed (between disciplines and patients) Need for both industry-funded and industry- independent studies Stab forskning, innovasjon og utdanning

13. Clinical research

14. A role for Nordic collaboration? Oppertunities and challenges Population size (rare diseases) Relatively homeogeneous Registries and biobanks Collaboration re. EU/international funding Well established collaboration in several milieus –Nordic clinical studies in cancer Possibly better access to novel treatment Sharing of health data Collaboration primarily with best partners Financing - Clinical studies (patient and study)  Multicenter  Phase 1 and 2 studies  More than cancer –Health research programs  Antimicrobial resistance  Personalised medicine Stab forskning, innovasjon og utdanning

15. Wants more Nordic clinical studies Stab forskning, innovasjon og utdanning

16. NordForsk

17. Nordic Trial Alliance Stab forskning, innovasjon og utdanning The purpose of the Nordic Trial Alliance (NTA) is to make it easier to carry out clinical research in the Nordic countries. Increased Nordic cooperation on clinical research will lead to a rise in the number of joint clinical trials and thus boost the attractiveness of the Nordic countries as partners in research. Such activities will also promote knowledge transfer as well as increased efficiency and research output. The Nordic Trial Alliance is based on established national networks for clinical research, and will lay the foundation for increased collaboration between national and Nordic stakeholders.

18. Nordic Trial Alliance has initiated projects to increase Nordic collaboration on clinical trials. Stab forskning, innovasjon og utdanning 1. Ethics 2. Monitoring of Clinical Research 3. Transparency and Registration 4. Collaboration between Industry and Academia 5. Pediatrics (strategic area) In July 2014 the NordForsk Board awarded funding to five additional research projects promoting joint Nordic clinical studies. Assisted reproductive technology and safety in the Nordic countries, Project leader: Anja Pinborg, Denmark Nordic Arthroplasty Register Association - an international quality register study of total joint arthroplasty of four nations, Project leader: Keijo Mäkälä, Finland NordStar, Project leader: Merete Lund Hetland, Denmark BMT in elderly AML - a prospective, controlled, international study, Project leader: Mats Brune, Sweden Discontinuation of infliximab therapy in patients with Crohns’ disease during sustained complete remission, Project leader: Mark Ainsworth, Denmark

19. Stab forskning, innovasjon og utdanning Nordic NECT The network is designed to promote patient access to new investigational drugs and access to phase I and early phase II programs in the Nordic countries Patient access to investigational drugs Today, many seriously ill cancer 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. 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.

20. Stab forskning, innovasjon og utdanning Objectives To make the Nordic region more attractive for early clinical studies. To perform state-of-art phase I and early phase II trials in oncology and hematology, to ensure the patients access to new investigational therapies. To work for a bilateral agreement between the Nordic countries allowing for inclusion of patients in early clinical trial protocols across the borders. To promote “One point of entry” for early clinical trials and common approval for the Nordic countries.

21. Possible focus for increased Nordic collaboration Clinical studies (more than cancer) –Rare diseases –Early phase studies –Multicentre studies Continue and expand established good collaboration –Nordforsk, incl Nordic Trial Alliance –Nordic NECT –Networks (ie cancer) Novel: –Personalised medicine –Antimicrobial resistance Stab forskning, innovasjon og utdanning

22. Forskningsutvalget, Oslo universitetssykehus og Universitetet i Oslo One of several action points at OUS re AMR, close collaboration with UiO 2 mill NOK pr year for 5 years, 1-3 prosjects Collaborative projects Criteria based on EUs Joint Programme Initiative regarding AMR Antimicrobial resistance - new focused research area at OUS

23. Stab forskning, innovasjon og utdanning The project should be within one or more of the following topics related to antimicrobial resistance: Therapeutics: The improvement of current antibiotics and the development of new antibiotics and alternatives for antibiotics. Diagnostics: New and improved diagnostics to stimulate better use of current antibiotics and support the development and use of new antibiotics and alternatives to antibiotics. Surveillance: A surveillance programme for AMR and antibiotic use in clinical settings. Transmission: A better understanding of the transmission mechanisms. Interventions: Studies of preventative or control interventions.

24. How to release the potential?? Political willingness Structural and legal issues Limited success without money? Stab forskning, innovasjon og utdanning