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Lene Hartmann's presentation from the Healthcare DENMARK Ambassador Summit
Denmark is positioned as an attractive country for clinical trials due to its strong institutions, efficient authorities, and educated patient population. Initiatives have been established to enhance collaboration with the industry, featuring a one-stop-shop service for trial coordination and national standard agreements. The Danish government aims to support clinical research growth, improve trial feasibility, and promote innovative trial units over the next five years.
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- 1. Clinical Trials OfficeDenmark Lene Hartmann Clinical Coordinator, Region Zealand October 27th 2014 Danish Regions Clinical Trials Office Denmark
- 2. WhychooseDenmark as testcountry for clinicaltrials? Danish Regions Clinical Trials Office Denmark •Stronginstitutions •Efficientauthorities •Health careregistries •Educatedpatient population
- 3. Clinicaltrialsper capita(1,2,3,4) DanishRegions Clinical Trials Office Denmark 0,0 5,0 10,0 15,0 20,0 25,0 30,0 35,0 40,0 45,0 50,0 www.clinicaltrials.gov (2012)
- 4. Politicalambitions arehigh! Moreresearch and innovation that creates VALUEthrough implementation and commercialization: ->Develop health care for the future ->Stimulate growth and development Danish Regions Clinical Trials Office Denmark Industry Hospitals Universities, Municipalitiesetc.
- 5. ClinicalResearch in Denmark Danish Regions Clinical Trials Office Denmark •The Government and Danish Regions agree that initiatives must be taken to secure growth •Clinical trials in cooperation with the industry are important –for economic growth and for treatment of patients •Denmark is doing very well –but like in many other western countries, the number of clinical trials have decreased for years
- 6. Clinicaltrialsin Denmark DanishRegions Clinical Trials Office Denmark Industry-initiated trials(2005-2010)
- 7. Goalto enhancecollaborationwith theindustry–The One Stop Shop Idea Danish Regions Clinical Trials Office Denmark •In 2010 The Capital Region of Denmark established an initiative to have a one point of entry service for the industry to the hospitals •In 2012 the one stop shop idea was extended to all 5 regions in Denmark through a political agreement with all regions
- 8. Danish Regions Clinical Trials Office Denmark •Each region has appointed a Clinical Coordinator and the coordinators work together as a 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 FormingThe ClinicalTrials Office Denmark –ClinicalNetwork
- 9. Keycharacteristicsfor succesfulperformance inclinicaltrials Danish Regions Clinical Trials Office Denmark •The industry would like: •easy access to investigators •committed investigators & nurses •focus on performance in clinical trials •fast start up of clinical trials •flexibility in the hospital system
- 10. ClinicalTrials Office Denmark–Site IdentificationService Danish Regions Clinical Trials Office Denmark •The national clinical network offers to assist the clinical site identification 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 Clinical Coordinators
- 11. FormingThe ClinicalTrials OfficeDenmark –Legal Network Danish Regions Clinical Trials Office Denmark •A national standard Clinical Trial Agreement has been made in collaboration between the regions and came into force May 2012 •Company specific National Standard Clinical Trial Agreements are developed
- 12. New National Initiatives Danish Regions Clinical Trials Office Denmark •To add information from patient registries to screen and better predict feasibility in clinical trials is a future possibility •Establishment of innovative Proof-of-concepttrial units; The Danish Government economically supports this over the next five years to attract early phase industry driven clinical research –INNO+
- 13. Clinicaltrialsin Denmark DanishRegions Clinical Trials Office Denmark Industry-initiated trials(2005-2013)
- 14. New website DanishRegions Clinical Trials Office Denmark www.clinicaltrialsdenmark.com Contact information Site identification requests Contracts/templates Disease-specific networks
- 15. 7 February 2014Danish Regions Clinical Trials Office Denmark Thankyou!
- 16. Back Ups 7February 2014 Danish Regions
- 17. Regional Denmark DanishRegions Clinical Trials Office Denmark Three political levels Government Five regions: Capital Region of Denmark Region Zealand Region Southern Denmark Central Denmark Region North Denmark Region 98 municipalities
- 18. Clinicaltrialsin Denmark DanishRegions Clinical Trials Office Denmark Total initiated trials(2005-2010)
- 19. Clinicaltrialsin Denmark DanishRegions Clinical Trials Office Denmark Total initiated trials(2005-2013)