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Senior Advisor, PhD Maj-Britt Juhl Poulsen Danish Regions Denmark

Senior Advisor, PhD Maj-Britt Juhl Poulsen Danish Regions Denmark. One Stop Shop for Industry to perform Clinical Trials in Denmark. Regional Denmark. Total 5.5 million inhabitants. Three political levels Government Five regions: Capital Region of Denmark Region Zealand

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Senior Advisor, PhD Maj-Britt Juhl Poulsen Danish Regions Denmark

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  1. Senior Advisor, PhD Maj-Britt Juhl Poulsen Danish Regions Denmark One Stop Shop for Industry to perform Clinical Trials in Denmark Danish Regions

  2. Regional Denmark Total 5.5 million inhabitants • Three politicallevels • Government • Five regions: • Capital Region of Denmark • Region Zealand • Region Southern Denmark • Central Denmark Region • North Denmark Region • 98 municipalities Danish Regions

  3. The regions owns the hospitals. • The governing bodies of the regions are the regional councils. The regional councils are each composed of 41 members directly elected for four-year periods. • The regions' main responsibility is health care, i.e. hospital service, including psychiatry as well as health insurance, general practitioners and specialists Danish Regions

  4. The Danes and the Health Care Sector • 9 out of 10 Danes are in contact with the health care sector every year • Every year, 2,5 million Danes are treated at a hospital • There are 53 public hospitals in Denmark with 18.303 beds Danish Regions

  5. My workplace • Danish Regions is the interest organisation for the five regions in Denmark • Danish Regions' overall mission is to safeguard the interests of the regions nationally as well as internationally.The most importanttasks of the organisation are: • to safeguard regional governmentinterests • to act as spokesman on behalf of the regions  • to negotiate the annualfinancial frames of the regions • to negotiatepay and workingconditions for regional employees Danish Regions

  6. The BurningIssue Number of apply’s for clinicaltrials – DK. Industry initiatedtrials Danish Regions

  7. It is possible to do something – the example of Japan The number of startedclinicaltrials in selectedcontries (www.clinicaltrials.gov). Én indgang for industrien til kliniske forsøg i Danmark, Report, Danish Regions, April 2012, www.regioner.dk Danish Regions

  8. The Arguments • Denmark is doing very well – but like in many other Western countries the number of clinical trials have decreased for years • The Government and Danish Regions agree in 2011 that initiatives must be taken to secure growth • Clinical trials in cooperation with industry are important – both for economic growth and for treatment of patience • Industry have argued the need for more standardised and efficient collaboration with the researchers in the public health service Danish Regions

  9. The Report Danish Regions

  10. The Group • The regions: Hans Okkels Birk, Bo B. Mikkelsen, Susanne Faarup Kudsk, Kristian Johnsen, Britta Smedegaard Andersen, Eva Maria O. Christiansen, Torben Bjerregaard Larsen • Interest organisations of industry: Pernille Nonboe, Rikke Arendt Christiansen, Jakob Bjerg Larsen, Anne-Marie Levy Rasmussen, Mille Keller Holst, Ghita Astrup, Bent Winding • Danish Regions: Maj-Britt Juhl Poulsen, Dennis Pihl Thomsen • TTO A/S: Peter Nissen Jørgensen Danish Regions

  11. Key characteristics for successful performance in clinical trials The industry would like: • easy access to investigators • committed investigators & nurses • focus on performance in clinical trials • flexibility in the hospital system Danish Regions

  12. The vision We will stop the decrease of number of clinical trials started by industry in Denmark. • We will measure on • New clinical trials started • Patient recruitment • Time to complete a clinical trial Danish Regions

  13. The One Stop Shop Idea • Can be carried out in many different ways • The most important is to make it easier to match the right collaborators • Time • Reliability • Predictability Danish Regions

  14. The Model – One point of Entry to Local Knowledge • Each region has appointed a One Stop Shop Coordinator and the coordinators work together as a formal network • The coordinators implement initiatives and act as link between researchers, industry, research infrastructure & administration • Danish Regions is leading the project and acts as secretariat and political co-ordinator Danish Regions

  15. The Model - Feasibility The national network offers to assist the feasibility process by suggesting names and contact details of potential investigators in specific clinical trials within four working days. The process is coordinated and industry gets one national, compiled feedback after contacting just one of the five regional One Stop Shop Coordinators Danish Regions

  16. The Model - The National Legal Network • Standard Clinical Trial Agreements have been made in collaboration between the regions and came into force May 2012 • A formal network of the regional lawyers is formed • Company specific National Standard Clinical Trial Agreements are developed Danish Regions

  17. Continued dialog betweenindustry and regions Regulary meetings are held betweenstakeholderslike regions, industri organizations, contract research organizations, the state, clinicians and so on Danish Regions

  18. New National Initiatives – for example • To add information from patient registries to better predict feasibility in clinical trials is a future possibility • Support establishment of research networks; in December 2013 a Network of Lung Medicine was formed which acts as One Stop Shop regarding industry feasibility in lung diseases. • Sundhed.dk - patientrecruitment Danish Regions

  19. ”Én Indgang” canbefoundherehttp://www.regioner.dk/sundhed/kvalitet+og+forskning/forskning/en+indgang Contact: Kenneth Hirsch Sørensen khs@regioner.dk Danish Regions

  20. Thankyou! Senior Advisor, PhD Maj-Britt Juhl Poulsen Danish Regions Denmark mjp@regioner.dk Danish Regions

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