position of clinical intervention research in the ... - knaw

Position of clinical intervention research in the Netherlands and recent trends

Huibert A.P. Pols, MD, PhDRikard Juttmann, MD, PhD

Erasmus University Medical Center Rotterdam

Introduction

Publication output- Quantity

- Quality

- Focus

Comparison with other countries General trends SWOT analysis Challenges

Number of publications on clinical trialsin the Netherlands

NL

0

100

200

300

400

500

600

700

2005 2006 2007 2008 2009

NL

Number of publications on clinical trials per university medical center

0

20

40

60

80

100

120

140

160

180

2005 2006 2007 2008 2009

12345678

Types of clinical research within top 100 best cited articles (2000-2008)

Drug trials (33)

Other clinical trials (17)

Guidelines/ decision making (13)

Explorative /association studies (7)

Others, including biomedical and meta-analyses (30)

100 highest cited publications within Clinical Medicine per research field

0

5

10

15

20

25

30

35

Onc/Hem Cardvasc IntM/End Infect Others

Field citation score Dutch universities per research field

0

0,5

1

1,5

2

2,5

3

3,5

Med Cardio Onco Neuro Hema Endo Surg Rad

Average number of citations per publication specifically on clinical

trials per university (NL)

02468

1012141618

2 1 8 6 4 3 7 5

2005/9

2005/9

Number of publications on clinical trials as percentage of world output

05

101520253035404550

2005 2006 2007 2008 2009

USA

England

Germany

France

Netherlands

Sw itzerland

Sw eden

Belgium

Output of publications on clinical trials per 1 million inhabitants

0

10

20

30

40

50

60

2005 2006 2007 2008 2009

Sw itzerland

Netherlands

Sw eden

Belgium

England

Germany

USA

France

World

Output of publications on clinical trials per 1 trillion (1012) US dollars BNI

0100200300400500600700800900

1000

2005 2006 2007 2008 2009

SwitNlSweBeUSAGerFr

Top European institutions in clinical medicineTimes Higher Education 21 May 2009

Data provided by Thomson Reuters’ Essential Science Indicators database, 1 January 1998-31 December 2008

Rank in Europe

1

2

3

4

5

6

7

8

9

10

University or Institute

Erasmus University Rotterdam

University of Cambridge

University of Oxford

University of Glasgow

University of Helsinki

Imperial College London

University of Amsterdam

Karolinska Institute

Humboldt University of Berlin

Leiden University

Papers

7,108

4,795

6,706

4,908

10,169

7,550

8,123

12,787

6,097

8,150

Citations

166,015

107,088

149,545

104,245

206,196

145,914

150,269

236,174

112,420

149,851

Citations/Paper

23.36

22.33

22.30

21.24

20.28

19.33

18.50

18.47

18.44

18.39

TOP EUROPEAN INSTITUTIONS IN CLINICAL MEDICINE

Times Higher Education

A B C D E F A B C D E F

1 20 Rotterdam 7108 166015 23,36 11 68 London (Univ) 16761 302182 18,03

2 25 Cambridge 4795 107088 22,33 12 77 Uppsala 6327 105962 16,75

3 26 Oxford 6706 149545 22,30 13 79 Milan 8722 145331 16,66

4 31 Glasgow 4908 104245 21,24 14 80 Utrecht 8416 137602 16,35

5 40 Helsinki 10169 206169 20,28 15 81 Aarhus 6340 103629 16,35

6 50 London (Imp) 7550 145914 19,33 16 82 Vienna 8579 140063 16,33

7 59 Amsterdam 8123 150269 18,50 17 84 London (Kings) 8359 136382 16,32

8 60 Karolinska 12787 236174 18,47 18 85 Maastricht 6274 100910 16,15

9 61 Berlin 6097 112420 18,44 19 88 Zurich 8638 137050 15,87

10 62 Leiden 8150 149851 18,39 20 89 Lund 8041 127533 15,86

A = Rank in Europe, B = Rank in the World, C = University, D = n Papers, E = n Citations, F = Citations per Paper

Data provided by Thomson Reuters essential Science Indicators database, 1 January 1998 – 31 December 2008

Number of universities in top 20 European institutions in clinical

medicine per country

UK 6

Netherlands 5

Sweden 3

Finland 1

Germany 1

Italy 1

Denmark 1

Austria 1

Switzerland 1

Average number of citations per publication on clinical trials per

country

0,00

5,00

10,00

15,00

20,00

Be Switz Fr Sw NL Eng USA Ger

2005/9

2005/9

Investigator initiated research compared with industry initiated research

(trends in Erasmus MC)

0

50

100

150

200

250

300

350

2004 2005 2006 2007 2008

Investigator-initiated Industrie geïnitieerd

Consequences of shift from industry to investigator initiated research

In industry initiated (drug) studies, trial vigilance is usually well organized by the industry partner

- Monitoring

- Data Safety Monitoring Board (DSMB)

In investigator initiated research, usually the UMC is responsible for the execution of these tasks

If investigator initiated clinical research increases, UMC’s will become more vulnerable, because of limited possibilities with regard to trial vigilance.

Other developments in Clinical Research

External development Effect on clinical research output

TI Pharma, CTMM Limited increase

Priority medicines for children and the elderly Increase

Industry initiated research Decrease

Personalized medicine (mostly investigator initiated)

Probably increase

Orphan drugs (ZONMW, EU) Increase

“Parelsnoer”- initiative Increase

Comments from the industry: Matches between Academia and Medical Life

Science Industry

Research culture Excellent scientific knowlegde and facilities Many key opinion leaders Clinical data quality Many bottom-up initiaties Logistic infrastructure

Comments from the industry: Mismatches between Academia and Medical Life

Science Industry

Regulatory and legislative measures Ethical approval timelines Local feasibility Small patient populations Clinical trial performance Cost development Attitude towards clinical research Organisational innovations in academic centres Cooperation between reachers

Strength• Strong clinical research tradition• Relatively high and still growing output • Prominent position in Europe

SWOT Clinical Research in The Netherlands(1)

Weakness• Funding research (children/elderly)• Suboptimal impact in relation to comparable countries• Suboptimal match with industry

Threats• Administrative load as result of legislation• Growing clinical work load• Limited clinical research funding

Opportunities• Large, compact, accessible population• Possibilities to improve (ICT) infrastructure• Investment in inter-academic cooperation

SWOT Clinical Research in The Netherlands(2)

What are our Challenges?

Publications: quality before quantity!

Coping with demands resulting from legislation- training young researchers (BROK)- further development of trial monitoring systems - Data Safety Monitoring Boards

Optimize (ICT) infrastructure- trial/data management software- data storage facilities- computer power: grid applications

Closer cooperation between UMC’s

Investment in networks, including government, industry, academia