Easy access to conduct clinical studies in Denmark/media/japan/Documents... · A Single Point of Entry Easy access to conduct clinical studies in Denmark Approach of by public Sector

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

1

2

3

4

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