Clinical research in Sweden

Transkript

1 Nordic Cooperation for Future Health Challenges Bergen, May 4, 2015 Starka tillsammans A report of inquiry into national coordination of clinical studies in Sweden Prof. Mats Ulfendahl Secretary-General for medicine and health Swedish Research Council mats.ulfendahl@vr.se

2 Clinical research in Sweden

3 Clinical research again and again and... Several very good proposals!

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5 Research and Innovation Bill 2012: A special Committee for clinical therapy research at the Swedish Research Council Jointly funded and governed by the Government and the County Councils (landstingen)

6 Clinical trials in Sweden Commercial CTs All CTs Non-Commercial CTs Källa: LV/EudraCT

7 CTs in the Nordic Countries Källa: Legemiddelverket, Norge

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9 Report by Ingrid Petersson 2013: Starka tillsammans

10 1993 Svenska stormaktstiden USA och Västeuropa hade särställning Företagen integrerade och nationella starka i Sverige Fokus på blockbusters Längre slutenvårdstider Sammanhållet hälso- och sjukvårdssystem Statlig läkemedelsfinansiering utan tak Nära och informellt samarbete industri vård akademi Betydande incitament för kliniker och individer 2013 Dagsläget Kunskapsutvecklingen global Industrin internationell Nya utvecklingsmodeller; externalisering och CRO Skräddarsydda behandlingar kräver specifika patienturval Större delar av vården utanför sjukhusen Offentliga och privata vårdproducenter Läkemedelskostnader integrerade i budgeten Nedgång i många jämförbara länder - många länder satsar Inför 2023 Trender och utmaningar Trender: Mer komplicerade prövningar som kräver specifik utrustning Färre patienter pga mer specifika studier? Nya affärsmodeller och samarbetsformer? Ökad konkurrens från många länder Internationell nedgång? Nödvändiga krav: Lätt hitta rätt patienter Snabba processer Bra incitament för vården att medverka på alla nivåer

11 Clinical studies more than clinical trials Clinical trials Well-defined processes for testing drugs and MedTech products Clinical development of medical technology Continuous and joint development rather than testing finished products Therapy studies (behandlingsstudier) Evaluation of specific treatments or methods Other studies E.g. explorative studies generating hypotheses rather than testing them

12 Ecosystem for clinical studies Research Authorities Health care Clinical studies Patients Industry Drug and MedTech market

13 Proposals within four areas National system for coordination Regional s and a centralized unit governed by a special committee Joint portal/interface for information and patient recruitment Special development projects with high priority More efficient regulatory processes Medical Products Agency (Läkemedelsverket), Ethics approval process, Biobanks etc. Improved national statistics and follow-up A working group to evaluate and propose new processes Steps towards establishing a research infrastructure for clinical studies!

14 Assignment from the government The Swedish Research Council to host a committee for national coordination of clinical studies to implement the proposals in Starka tillsammans Funds allocated for national coordination, e.g.: national development projects support to the healthcare regions for their work with clinical studies A special unit for national coordination located in Gothenburg

15 Committee for national coordination of clinical studies Structures supporting collaboration Portal with information on trial sites, studies etc. Joint development projects Support functions Joint support systems, training, knowledge exchange Conferences, workshops, seminariers Central point of contact for international and national players National pilot studies Interface for inquiries External monitoring Promoting Sweden as a study site Coordination of regional s, distribution of joint assignments and resources

16 Regional Regional Regional Central unit Regional Regional Regional

17 Organisation Committee Independent chair and 9 members appointed by the government after nominations by The Swedish Association of Local Authorities and Regions (SKL) - 3 The Association of Private Care Providers - 1 The Swedish Association of the Pharmaceutical Industry (LIF) 1 Swedish Medtech 1 SwedenBio - 1 Swedish Research Council 2 Advisory Group Operational unit in Gothenburg Close collaboration with regional s Reference and project groups when required Budget 2015: 40 million SEK

18 The regional s Regional Regional Regional Supporting the initiation of studies Finding study partners Identifying and/or recruiting patients Assistance with applications (e.g. ethics approval) Supporting ongoing studies with Statistics, health economics etc. Legal counselling Administration etc. Participation in the national system Regional Central unit Regional Regional

19 Regional s linked to the six existing healthcare regions Norra sjukvårdsregionen: Forum Norr för klinisk forskning. Uppsala-Örebroregionen: A freestanding unit linked to Uppsala Clinical Research Center (UCR). Stockholms sjukvårdsregion: Karolinska Trial Alliance (KTA). Västra sjukvårdsregionen: Gothia Forum Södra sjukvårdsregionen: FoU-centrum Skåne. Sydöstra sjukvårdsregionen: Forum sydost,

20 Objectives Recognized role for clinical research in healthcare Improved incentive structures for clinical research Stronger links between research, healthcare and industry Focus on patient benefits and patient involvement Optimized processes for research funding Synergistic effects through better coordination Better (functioning...) IT systems in the healthcare sector

21 Key success factors Patient involvement Trust and long-term relations between healthcare, academy and industry Clinical research and development as an integrated part of the day-to-day healthcare processes Quick and efficient regulatory processes Compatible systems and processes for recruiting patients throughout the nation Beneficial career paths for clinical research scientists Efficient systems for national, Nordic and international collaboration

22 Possibility for synergistic effects Patient registers Clinical therapy research Biobanks Cancer centra Professional networks

23 Thank you for your attention!