Supporting Clinical Trials Dr. Frank Wissing (DFG)

Transcription

1 Supporting Clinical Trials Dr. Frank Wissing (DFG)

2 Topics Who is the DFG? IITs in Germany Funding of Clinical Trials by the DFG (and others) Outlook

3 The DFG s mission Statement The DFG in a nutshell serves all branches of science and the humanities fosters scientific excellence through competition (peer review) supports international cooperation in research owned by scientists run by scientists Portfolio of flexible funding instruments Funding in 2012, by scientific discipline Engineering Sciences million (21.5%) Natural Sciences million (24.4%) Humanities and Social Sciences million (15.5%) Life Sciences million (38.6%)

4 Amount of research funding* awarded by research area for each calendar year 2009 to 2012 Biology Medicine Argriculture, Forestry, Horticulture and Veterinary Medicine * Funding amounts refer to both new and ongoing projects in the individual grants and coordinated programmes that receive funding in the year shown.

5 Topics Who is the DFG? IITs in Germany Funding of Clinical Trials by the DFG (and others) Outlook

6 Situation in Germany Health System: - ~ 200 Health Insurance Companies - health care providers fragmented Research System: - Separation between project funding and institutional funding - Separation between Länder- and central funding - Separation between basic research and applied research - Only universities with full research spectrum, but lacking core funding Regulatory System: - Many regulatory bodies on Länder -level - About 60 independent ethics committees - 4 central regulatory bodies (Bfarm, PEI, RKI, BfS)

7 Why we need Confirmatory Clinical Trials? Stakeholders Knowledge Use Patient Clinical Scientific Industry Societal Efficacy Effectiv eness Safety Marketing Approval RCT Costs Clinical Guidelines Disease Mechanisms Clinical Research

8 Why we need Confirmatory Clinical Trials? Stakeholders Knowledge Use Patient Clinical Scientific Industry Societal Efficacy Effectiv eness Safety Marketing Approval RCT Costs Clinical Guidelines Disease Mechanisms Clinical Research

9 Why we need Confirmatory Clinical Trials? Stakeholders Knowledge Use Patient Clinical Scientific Industry Societal Efficacy Effectiv eness Safety Marketing Approval RCT Costs Clinical Guidelines Disease Mechanisms Clinical Research

10 Who funds confirmatory IITs in Germany Industry German Research Foundation (DFG) Ministry for Research and Education (BMBF) University Core Funding Private Foundations EU Helmholtz Association Health Insurers Max-Planck-Association Fraunhofer Association Leibniz Association Ministry of Health (BMG) J J J J J J J J J J (J ) (J ) L L L L

11 Topics Who is the DFG? IITs in Germany Funding of Clinical Trials by the DFG (and others) Outlook

12 Clinical Trials Biomedical Research basic disease oriented patient oriented Interventional Clinical Studies exploratory confirmatory other: observational, epidemiological, genetic, public health etc.

13 Funding exploratory studies by the DFG Exploratory or observational studies on humans (e.g. early phase, translational, epidemiological, noninterventional) Funding via the regular project funding, e.g. individual grants coordinated funding programmes fellowships junior research groups estimated Mio Euro p.a. DFG funding

14 Observations for IITs in Germany Often study quality in comparison to the international standards too low Too few studies are being performed and published Low acceptance in medical faculties High manpower needed Too few young clinical investigators

15 Specific Problem: Funding for large, confirmatory clinical trials often limited Few funding options for non-industry funded trials 2003: Specific Funding instrument Goal: Long-term improvement of clinical trial quality and increase of acceptance of clinical studies in the scientific community and public

16 Which types of trials are eligible in the programme? confirmatory prospective multicentre clinical trials with patients a) controlled interventional therapeutical trials b) diagnostic studies (Phases II-IV according to Sackett) c) controlled interventional trials on secondary prevention d) prognostic studies e) systematic reviews (BMBF) Not: Trials where companies have direct commercial interest in the results

17 Main Criteria for the Peer Review Identification of the most excellent and most important trials by asking: " Is the clinical impact high? Will the trial make a powerful difference in patient care in the immediate future? " Is the trial internationally competitive? " Is the trial feasible? " Is the trial methodology sound? " No bonus for any discipline, only quality counts Peter Fonagy, London

18 Calls and Proposals (DFG+BMBF, ) 1. Call 2. Call 3. Call 4. Call 5. Call 6. Call 7. Call 8. Call Total Budget 10 Mio 20 Mio 20 Mio 30 Mio 30 Mio 30 Mio 30 Mio 30 Mio Outlines reviewed Invited Proposals (+4) 54(+3) funded trials 17 (41%) 18 (58%) 21 (51%) 23 (35%) 16 (28%) 20 (34%) 14 (30%) 18 (44%) rejected 24 (59%) 13 (42%) 20 (49%) 42 (65%) 41 (72%) 39 (66%) 33 (70%) 23 (56%)

19 Clinical Trials: Areas of proposals Numbers of outlines and proposals submitted and funded Outlines Full Proposals Funded Proposals

20 Some numbers Example 7. Call 2011 Min Max Average Patients/Trial Centers/Trial Management ( /a) Monitoring ( /Patient/ Center) Casepayments ( / Patient) Medication ( /Patient) Insurance ( /Patient) Patient Budget ( /Patient) Total Budget ( ) (47 Full proposals; DFG-proposals only year 1-3; Patients N total = ; Centers N total = 612

21 Support by KKS and CRO Survey March N Yes, KKS Yes, CRO No Other ja, KKS ja, CRO nein Sonstige 21

22 Example: KKS in the 5th Call Ca. 200 submitted outlines (DFG und BMBF) Of these 62 with search word KKS or ZKS (DFG und BMBF) 37 full proposals at DFG Of these 24 with KKS support 11 funded proposals at the DFG Of these 9 with KKS support

23 Delayed Recruitment 16 Status current Recruitmentphase (2011) (n=51) N >160 Current recruitment in relation to plan (March 2011) Currently under plan Currently above plan

24 Results of DFG-funded trials (Started ) 74 trials funded 9 with final report (May 2014) 7 with final publication (average 6 publications/trial) Results published in (British J Psychiatry, NEJM, Epidemiology and Psychiatric Sciences, Eur Psychiatry, Behav Brain Res., Arch Int Med., Ann Rheum Dis., 2 in preperation) 10 stopped/never started

25 Accompanying Measures: Examples Infrastructures: 12 Coordinating Centres for Clinical Trials (since 1998) 6 Study Centres (since 2006) National Trial Register (WHO, since 2008) Centres for Translational Health Research (Cancer, Diabetes, Heart, Lung, Infection, Neuro) Research Networks/Consortia 40 Clinical Research Units Competence Networks in Medicine Cancer Trials / Compr. Cancer Centres Training Junior Training Academy Clinical Trials

26 Funding Clinical Trials since 2013 Regular Programme, open topic 2 stages; standing scientifc committee; up to 15 Mio p.a. Annual Calls, as yet open topic 2 stages, stage 1: Relevance Board; stage 2: Scientific Board; up to 15 Mio p.a. Topics initiated by Federal Joint Committee (G-BA) or suggested by applicants/companies; Study design by G-BA, advertised, study group selected by G-BA

27 Topics Who is the DFG? IITs in Germany Funding of Clinical Trials by the DFG (and others) Outlook

28 Outlook Further Challenges and Solutions High economic pressure on university clinics/less time for research High costs due to high regulatory burden adequate budget planning and funding risk adapted approach (insurances, fees, monitoring, safety)? Trials with high socio-economic relevance / low scientific interest prioritising and funding by health insurers / health politics? Funding for multinational trials Lead Agency procedures by national funders? Joint agreements? European wide funding via EU?

29 Thank you very much for your attention! Frank Wissing German Research Foundation (DFG) Further information