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LMI Kliniske studier og veien videre ǀ Oslo ǀ March 30th 2017
Kristian Teglkamp, MD, MSci Pharm Med ǀ Clinical Trials Office Denmark
What we do and what we offer
Clinical trials in Denmark
Industry-initiated trials (2005-2010)
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120
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160
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240
2005 2006 2007 2008 2009 2010
Source: Danish Health and Medicines Authority. Annual report 2014 - Clinical trials of medicines
Political ambitions are high!
More research and innovation that creates VALUEthrough implementation and commercialization
MorePublic & Private
Partnerships
We dare compare – Denmark versus rest of Europe
Our Goal is to enhance collaboration with the industry
• 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
• A national standard Clinical Trial Agreement has been made
• Company specific National Standard Clinical Trial Agreements are developed
Why choose Denmark as test country for clinical trials?
Strong Institutions
Efficient Authorities
Health Care Registries
Educated Patient Population
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Clinical trials in Denmark
Industry-initiated trials (2005-2015)
Source: Danish Health and Medicines Authority. Annual report 2016 - Clinical trials of medicines
100
120
140
160
180
200
220
240
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
KØSKOMMUNALØKONOMISKSUNDHEDSINFORMATIONSGRUNDLAG
We have access to
Finding the right sites
Finding the right patients
What type of information do we need to support you the best way?
Is a feasibility at all needed?
Provide the relevant ICD10 diagnosis code
Are you interested in a specific age group?
Not able to do specific in- and exclusion criteria…..yet
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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&
DepartmentsIn Denmark
Total numberof patients
RESEARCH NETWORKAccess to
We know it worksCase: 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
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 Medicines1. 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
DanPedMedParticipating Pediatric Units
The Capital Region of DenmarkRigshospitalet
HerlevHillerødHvidovre
Region ZealandNykøbing FNæstvedRoskildeHolbæk
The Region of Southern Denmark
OdenseKoldingEsbjerg
Aabenra
Central Denmark RegionRandersHerningSkejbyViborg
The North Denmark Region
HjørringAalborg
DanPedMed – Contact Person(Danish Investigators Network for Paediatric Medicines)
Marie Louise S. Nilsson
Coordinator for DanPedMed
Dept. of Paediatrics & Adolescent Medicine Section 5054Rigshospitalet, Blegdamsvej 9DK-2100 Copenhagen, Denmark
Phone +45 3545 9667Fax +45 3545 3935E mail: [email protected]
Phase IV-Unit– an access to the primary care sector
They Offer• Access to 280 research interested GP’s nationwide
• Finding eligible research participants via registries
• Staff fully trained in GCP standards
• Quality assurance of the science behind the industry study
• Capabilities of running other types of studies than Phase IV
ContactPhase IV-Unit
J.B. Winsløws Vej 25, 1.5000 Odense C
Professor Jesper [email protected]
COMPANY VISITSA direct way of communicating
We would like to do more visits
Regards from the Clinical and Legal coordinators at
Clinical Trial Office Denmark
PIPELINEIdeas and projects in the
MORE COMPANY VISITS PRICING PATIENT RECRUITMENT
PRICINGOverview
Pricing ambition
• We would like to prepare a framework for a national price list with a few key examples of tariffs including a price range for a defined service
• We will refer to the individual regional websites for detailed price lists
• The model must be sufficiently flexible so that tasks organized and priced differently in each regions will still be accessible
• The information on prices for each project service should meet the requirements of the Danish Competition and Consumer Authority and fit into the decree of July 2014 from the Ministry of Health and their guidance document from October 2016
• The price ranges should be approved by the five regional research directors
PATIENT RECRUITMENTA focus area
Inquiries 2016
90% of all inquiries arehandled within
4 days
01020304050607080
Number of inquiries and rate of response 2016
15 %
10 %
13 %
18 %
34%
10%
Rate of response in percentage, 20160 days 1 day 2 days
3 days 4 days 5 days +>
www.clinicaltrialsdenmark.com
be fast and know our own backyard
create more clinical networks for fast and accurate feasibility responses
collaborate with the Ministry of Foreign Affairs and embassies in order to support clinical trials
be an asset for the patients, the researchers and the companies
We would recommend to…..
Kristian Teglkamp, MD, MSci. Pharm.MedSenior Executive Advisor, Clinical Trial Office Denmark, Capital Region
Direct: +45 20 59 93 72E-mail: [email protected]
Center of Regional DevelopmentResearch & InnovationThe Capital Region of DenmarkKongens Vaenge 2DK-3400 HilleroedDenmark
