Clinical Trials Office Denmark

Lene HartmannClinical Coordinator, Region Zealand

October 27th 2014 Danish Regions

ClinicalTrials Office

Denmark

Why choose Denmark as test country for clinical trials?

Danish Regions

ClinicalTrials Office

Denmark

• Strong institutions

• Efficient authorities

• Health care registries

• Educated patient population

Clinical trials per capita (1,2,3,4)

Danish Regions

ClinicalTrials 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)

Political ambitions are high!

More research and innovation that creates VALUEthrough implementation and commercialization:

-> Develop health care for the future

-> Stimulate growth and development

Danish Regions

ClinicalTrials Office

Denmark

Industry

Hospitals

Universities,

Municipalities etc.

Clinical Research in Denmark

Danish Regions

ClinicalTrials 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

Clinical trials in Denmark

Danish Regions

ClinicalTrials Office

Denmark

Industry-initiated trials (2005-2010)

Goal to enhance collaboration with the industry – The One Stop Shop Idea

Danish Regions

ClinicalTrials 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

Danish Regions

ClinicalTrials 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

Forming The Clinical Trials Office Denmark – Clinical Network

Key characteristics for succesfulperformance in clinical trials

Danish Regions

ClinicalTrials 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

Clinical Trials Office Denmark – Site Identification Service

Danish Regions

ClinicalTrials 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

Forming The Clinical Trials Office Denmark – Legal Network

Danish Regions

ClinicalTrials 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

New National Initiatives

Danish Regions

ClinicalTrials 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+

Clinical trials in Denmark

Danish Regions

ClinicalTrials Office

Denmark

Industry-initiated trials (2005-2013)

New website

Danish Regions

ClinicalTrials Office

Denmark

www.clinicaltrialsdenmark.com

Contact information

Site identification requests

Contracts/templates

Disease-specific networks

7 February 2014 Danish Regions

Clinical Trials Office Denmark

Thank you!

Back Ups

7 February 2014 Danish Regions

Regional Denmark

Danish Regions

ClinicalTrials 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

Clinical trials in Denmark

Danish Regions

ClinicalTrials Office

Denmark

Total initiated trials (2005-2010)

Clinical trials in Denmark

Danish Regions

ClinicalTrials Office

Denmark

Total initiated trials (2005-2013)