Position of clinical intervention research in the Netherlands and recent trends

Transcription

1 Position of clinical intervention research in the Netherlands and recent trends Huibert A.P. Pols, MD, PhD Rikard Juttmann, MD, PhD Erasmus University Medical Center Rotterdam

2 Introduction Publication output - Quantity - Quality - Focus Comparison with other countries General trends SWOT analysis Challenges

3 Number of publications on clinical trials in the Netherlands NL NL

4 Number of publications on clinical trials per university medical center

5 Types of clinical research within top 100 best cited articles ( ) Drug trials (33) Other clinical trials (17) Guidelines/ decision making (13) Explorative /association studies (7) Others, including biomedical and meta-analyses (30)

6 100 highest cited publications within Clinical Medicine per research field Onc/Hem Cardvasc IntM/End Infect Others

7 Field citation score Dutch universities per research field 3,5 3 2,5 2 1,5 1 0,5 0 Med Cardio Onco Neuro Hema Endo Surg Rad

8 Average number of citations per publication specifically on clinical trials per university (NL) 2005/ /9

9 Number of publications on clinical trials as percentage of world output USA England Germany France Netherlands Sw itzerland Sw eden Belgium

10 Output of publications on clinical trials per 1 million inhabitants Sw itzerland Netherlands Sw eden Belgium England Germany USA France World

11 Output of publications on clinical trials per 1 trillion (10 12 ) US dollars BNI Swit Nl Swe Be USA Ger Fr

12 Top European institutions in clinical medicine Times Higher Education 21 May 2009 Data provided by Thomson Reuters Essential Science Indicators database, 1 January December 2008 Rank in Europe University or Institute Papers Citations Citations/Paper 1 Erasmus University Rotterdam 7, , University of Cambridge 4, , University of Oxford 6, , University of Glasgow 4, , University of Helsinki 10, , Imperial College London 7, , University of Amsterdam 8, , Karolinska Institute 12, , Humboldt University of Berlin 6, , Leiden University 8, ,

13 TOP EUROPEAN INSTITUTIONS IN CLINICAL MEDICINE Times Higher Education A B C D E F A B C D E F 1 20 Rotterdam , London (Univ) , Cambridge , Uppsala , Oxford , Milan , Glasgow , Utrecht , Helsinki , Aarhus , London (Imp) , Vienna , Amsterdam , London (Kings) , Karolinska , Maastricht , Berlin , Zurich , Leiden , Lund ,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 December 2008

14 Number of universities in top 20 European institutions in clinical medicine per country UK 6 Italy 1 Netherlands 5 Denmark 1 Sweden 3 Austria 1 Finland 1 Switzerland 1 Germany 1

15 Average number of citations per publication on clinical trials per country 2005/9 20,00 15,00 10, /9 5,00 0,00 Be Switz Fr Sw NL Eng USA Ger

16 Investigator initiated research compared with industry initiated research (trends in Erasmus MC) Investigator-initiated Industrie geïnitieerd

17 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.

18 Other developments in Clinical Research External development Effect on clinical research output TI Pharma, CTMM Priority medicines for children and the elderly Industry initiated research Personalized medicine (mostly investigator initiated) Orphan drugs (ZONMW, EU) Parelsnoer - initiative Limited increase Increase Decrease Probably increase Increase Increase

19 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

20 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

21 SWOT Clinical Research in The Netherlands(1) Strength Strong clinical research tradition Relatively high and still growing output Prominent position in Europe Weakness Funding research (children/elderly) Suboptimal impact in relation to comparable countries Suboptimal match with industry

22 SWOT Clinical Research in The Netherlands(2) Opportunities Large, compact, accessible population Possibilities to improve (ICT) infrastructure Investment in inter-academic cooperation Threats Administrative load as result of legislation Growing clinical work load Limited clinical research funding

23 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