Danish Respiratory Research Network

Lene Hartmann, Cand. pharm

Clinical Trial Office Denmark – Region Zealand

National Coordinator DRRN

Årsmøde DanPedMed 2017

Clinical Trials Office Denmark

• Single point of entry service for the industry to all the hospitals in Denmark

• Site identification

• Link between researchers and industry

• Legal advice

• Handling of national issues and implementation of initiatives

• Standard templates

• Infrastructures – disease specific networks

•

Key Characteristics for Succesful Performance in Clinical Trials

Easy access to investigators

Committed investigators & nurses

Focus on performance in clinical trials

Fast start up of clinical trials

Flexibility in the hospital system

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•

•

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The industry needs

Attraction of global studies

BUILDING SPECIALIST RESEARCH NETWORKS

Gentofte

Hillerød

Hvidovre

Bispebjerg

Hjørring

Aalborg

Roskilde

Holbæk

Næstved

Aarhus

Randers

Viborg

Holstebro

Silkeborg

Horsens

Odense

Danish Respiratory Research Network

Kolding

Sønderborg

National Coordinator

VIP Silkeborg

VIP Odense

VIP Hvidovre

TAP Odense

Værløse

Helsingør

Holte

DRRN – Focus Areas

2014-2015

• Feasibility process

• CDA standards with several companies

• English web

• Site profile

• NEXT application

2016

• Feasibility TCs

• Collaboration of ongoing trials

• Budgets

• NEXT integration

2017

• Keeping momentum for phase III studies

• Database

CRO/Pharma company 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. TC.

The national coordinator collects input from the entire network CRO/Pharma are now able to contact relevant sites

CRO/Pharma company

The National Coordinator

(Respiratory medicine)

Respiratory Research Network

The National Coordinator

(Respiratory medicine)

CRO/Pharma company

DRRN - Site feasibility process

What’s in it for DRRN

• One source for feasibilities

• All departments are given opportunity to participate

• Possibility for discussion of clinical trials and minimising barriers for succesful conduct of these

• Focus the efforts to fewer studies with more patients, i.e. better ressource utilisation

• One negotiation

What’s in it for the Industry

• Easy access to all respiratory departments in Denmark

• 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

• One negotiation

PDF site profiles

On the web www.drrn.dk

2016 Total 22

No info yet/on hold

NO Study in DK

Study in DK

Feasibility Overview

2014 Total 21 2015 Total 26

Experiences

• Positive attitude from members and industry

• New opportunities

• Formalised ongoing communication enables more robust estimation of feasibility assessments and coordination

• Validation of input

• Discussion of challenges/opportunities

• Coordination between sites

• Succesful NEXT application

LMS årsrapport 2015 - Resp

0

5

10

15

20

25

2013 2014 2015

antal forsøg

antal forsøg

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Continuous focus

Easy access to investigators

Committed investigators & nurses

Focus on performance in clinical trials

Fast start up of clinical trials

Flexibility in the hospital system

•

•

•

•