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A Single Point of Entry Easy access to conduct clinical
studies in Denmark
Approach of by public Sector supporting medical industries ǀ JPMA, Tokyo ǀ November 10th 2015
Kristian Teglkamp, MD, MSci Pharm Med ǀ The Capital Region of Denmark
Why choose Denmark as test country for clinical trials?
Strong Institutions
Efficient Authorities
Health Care Registries
Educated Patient Population
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We dare compare – Denmark versus rest of Europe
Number of studies per country Phase I-IV
0
200
400
600
800
1000
1200
Ranking of countries - absolute numbers
Source: http://www.efpia.eu/uploads/Modules/Documents/2014_08_05_efpia---publicis-clinical-trials-survey-part-1.pdf
…….However, we are less than 6 million Danes
Number of studies per capita changes everything
40.4 39.6
30 25.9 24.8 24.6 24.3 24.2 23.4 22.6
0
5
10
15
20
25
30
35
40
45
Denmark Belgium Estonia Switzerland Austria Hungary Sweden CzechRepublic
Norway Netherlands
Source: Danish Association of the Pharmaceutical Industry (Lif), November 2014, measured by www.clinicaltrials.gov.
Clinical trials per million capita
…….Denmark is the country in the world that conducts the most clinical trials
Similar picture if we look at number of patients recruited
Source: http://www.efpia.eu/uploads/Modules/Documents/2014_08_05_efpia---publicis-clinical-trials-survey-part-1.pdf
0
500
1000
1500
2000
2500
3000
3500
Ranking of countries which recruited more than 200 patients per million inhabitants
05000
1000015000200002500030000350004000045000
Ranking of countries which recruited more than 5000 patients
Example of high expertise and interventions in cardiovascular interventions
Source: European Collaboration for Healthcare Optimization http://echo-health.eu/wp-content/uploads/2014/12/report_CV_DNK.pdf
Our Goal is to enhance collaboration with the industry
“Clinical Trials Office Denmark”
• Is a single point of entry service for the industry to all the hospitals in Denmark
• All coordinators implement initiatives and act as link between: • Researchers
• Industry
• Research infrastructure & administration
• We can facilitate the perfect match for any clinical industry sponsored study
Finding the right sites
Finding the right patients
Rare diseases – finding the right patients
Case: Alagille syndrome • A genetic disorder that can affect the liver, heart, and other parts of the body • The estimated prevalence of Alagille syndrome is 1 in 70,000 newborns
Disease code
Hospitals &
Departments In Denmark
Total number of patients
Inquiries January – October 2015
92% of all inquiries are
handled within
4 days
THE DANISH PAEDIATRIC RESEARCH NETWORK
Access to
• In 2014 we had 17 industry initiated paediatric clinical studies in Denmark
• Besides doing investigator initiated clinical studies the capacity for conducting more clinical studies are available in Denmark
• A formal paediatric research network are under development to handle an increase in studies
Paediatric studies - today and tomorrow
DanPedMed (Danish Investigators Network for Paediatric Medicines)
• 40-70% of medicines given are not registered for children
• Evidence-based knowledge of new drugs and already
approved drugs are needed
The Danish Investigators Network for Paediatric Medicines
1. Delivers an easy access to pediatricians for new knowledge about
existing drugs on the market where there are no controlled, dose-
effect drug studies in children
2. Can influence the development of new drugs
3. Provides input for new research on medicines for children in
Denmark - and the Nordic countries - to create an optimal
environment for clinical research in Denmark
We know it works Case: Danish Respiratory Research Network
• Easy access to all respiratory departments in Denmark
• Industry have noticed that the feasibilities provided by the research network are highly reliable and achievable – an outstanding competitive factor
• Faster start up of clinical trials
• Forum for dialogue of • Clinical issues related to respiratory diseases
• Clinical trial design
• Challenges related to the conduct of ongoing clinical trials in the network
http://www.regioner.dk/clinicaltrialsdk/clinical+trials+office+denmark/disease+specific+networks/danish+respiratory+research+network
CRO/Pharma
Contacts the national
coordinator:
• Information
regarding the
clinical study
• Any questionnaire
• Confidentiality
Agreement
All inquiries will be
distributed to the
entire network
All members of the
network evaluates
and makes a decision
whether they can
participate in the
study
the national
coordinator collects
input from the entire
network and returns
following to the
CRO/Pharma: • A list with interested
sites
• All questionnaires
CRO/Pharma are
now able to contact
relevant sites
CRO/pharma The National Coordinator
(Respiratory medicine)
Respiratory Research Network
The National Coordinator
(Respiratory medicine)
CRO/pharma
Site feasibility process for the Danish Respiratory Research Network
Successful collaboration agreements between The Capital Region, Academia and Industry
More Public & Private
Partnerships
Examples of projects
The establishment of the Danish Respiratory Research Network
Conference on the use of health outcome studies as a steering instrument in the Danish healthcare sector
Develop joint training courses with easier knowledge sharing for health professionals in the public and private sectors
Outcome steering model based on psoriasis treatment
Support early intervention and diagnosis of type 2 diabetes
Focus on documenting efficacy and safety of medicines for children
Be fast and know your own backyard
We create clinical networks for fast and accurate feasibility responses
We collaborate with our local Ministry of Foreign Affairs and embassies in order to support clinical trials in our country
We mention the obvious – size matter when you are a small country
Join your allies and be better at thinking as one cluster
Be Inspired
www.clinicaltrialsdenmark.com
• Contact information
• Clinical Site identification
• Contracts/templates
• Disease-specific networks