Funding of patient-oriented clinical research by the German Federal Ministry of Education and Research (BMBF)
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1 Funding of patient-oriented clinical research by the German Federal Ministry of Education and Research (BMBF) Dr. Steinmüller/ Dr. Jacobs July 8th, 2011, Cologne
2 Overview Health research programme of the Federal Ministry of Education and Research General information The framework programme BMBF/ DFG funding activity Clinical trials (and systematic reviews) Overview Summary of survey results
3 Project Management Agency in the German Aerospace Center () Non-governmental, non-profit project management organisation Department of Health Research 71 scientific & 64 administrative staff Mandated by the Federal Ministry of Education and Research (BMBF) Administrates the Health Research Programme of BMBF (implementation, administrative & scientific controlling, monitoring, evaluation, participation in planning of funding initiatives)
4 Health Research Framework Programme: Criteria for constituting new funding priorities Societal need: number of people affected, mortality and morbidity Obvious gaps in health care, economical and individual burden Significance for the health care system Potential for scientific and technological innovations Potential to strengthen top-level research Potential for economic exploitation
5 Health Research Framework Programme: General information Cross-departmental framework programme of the German Federal Government managed by BMBF Valid for the next 8 years ( ) Planned budget of BMBF : ~ 5,5 billion Euro (includes institutional funding, project funding, federal share of the German Research Foundation (DFG)) Additional budgets of other federal departments
6 Health Research Framework Programme: Six fields of action Focussed research into major diseases (e.g. Health research centres, rare diseases) Individualised medicine (e.g. basic/preclinical/clinical research, specific diseases relevant for certain population groups) Research into prevention and nutrition (e.g. Epigenetics, environmental-related health research, vaccine development) Research into health care (e.g. centres for research in health economics, young scientists programme) The health care industry (e.g. medical technology, telemedicine, part of high-tech strategy) International cooperation in health care (e.g. ERA-Net, Joint programming, neglected and poverty-related diseases)
7 BMBF strategy for patient-oriented clinical research: Research infrastructures Kiel/Lübeck Hannover Berlin Münster Düsseldorf Köln Marburg Halle Leipzig Dresden Mainz Heidelberg KKS Tübingen PaedNet ChirNet KKS network office Clinical study centre Freiburg München
8 BMBF/DFG funding activity Clinical trials : General information BMBF and DFG have launched a joint initiative for patient-oriented medical research in Germany a novelty For the first time clinical trials and systematic reviews can be financed independently of specific thematic funding programmes In 2010: 30 million p.a. by BMBF + DFG (15 mio. each) Joint reviewing process for clinical trial applications Separate reviewing of systematic review applications
9 BMBF/DFG funding activity Clinical trials : Objectives To further improve the quality and safety of health care for patients To implement international state-of-the-art expertise and methodology in clinical trial research in Germany To increase awareness and acceptance of evidence-based medicine in science and the population
10 BMBF/DFG funding activity Clinical trials : Which types of proposals are eligible? Prospective multicentre clinical trials with patients Systematic reviews according to international standards Systematic reviews Individual patient data analysis Prognostic reviews Network analysis Meta-meta-analysis Reviews on drug safety/ adverse events Diagnostic reviews Reviews including non-rct or qualitative trials Updates on systematic reviews Cooperation with the Cochrane Collaboration is recommended, but not mandatory
11 BMBF/DFG funding activity Clinical trials : Evaluation criteria for systematic reviews Need for the group of patients Impact of the results on clinical practice Methodological progress in the field of systematic reviews Design and methodology of the proposed review Expertise of the applicants
12 BMBF/DFG funding activity Clinical trials : History Proposals Funded proposals Funding rate 2005/ % 2006/ % 2007/ % 2008/ % 2009/ % 2010/ %
13 BMBF/DFG funding activity Clinical trials : Survey Based on an online-questionnaire in March/ April 2011 Addressed to all funded projects Presented at an evaluation workshop on May 31 st / June 1 st, 2011 Return rate 61 of 78 BMBF-funded systematic reviews answered the questionnaire (Return rate: 78%) Summary of the results
14 Medical fields of funded systematic reviews Psychiatry / Psychology 20 Haematology / Oncology 16 Surgery 10 Other 7 Cardiology 6 General medicine 4 Pharmacology Dermatology Mio bewilligt Neurology 2 Anaesthesiology 2 Radiology Ophthalmology Gynaecology Gastroenterology
15 Types of funded systematic reviews Standard review 36 Individual patient data (IPD) analysis 8 Other 4 Prognostic review Network analysis Inclusion of qualitative primary studies Meta-meta-analysis Review on drug safety/ adverse events Diagnostic review Update of a systematic review
16 Delay in conduct of the review in the following steps: Publication (peer-review process) 17 Data extraction 10 Literature search and evaluation 10 Preliminary steps (Definition of search algorithms, In- /Exclusion criteria of studies etc.) 9 Data synthesis 6 Collection of individual patient data
17 Contribution of international collaborators Support by methodological expertise 16 Support by clinical expertise 12 Support in literature search 12 Peer-review of protocol and manuscript 11 Transfer of individual patient data 8 Support in quality rating of primary studies 5 Support in data extraction from primary studies
18 Long-term effects of funding Implementation of EBM infrastructure or cooperation 45 Transfer of results into clinical practice 22 Additional scientific research on basis of results from syst. review 21 Impact on national/ international guidelines 20 Other publications arouse from the funded systematic reviews (until today)
19 Long-term effects of funding: infrastructures and cooperations Constant/ active collaboration with respective Cochrane Review Group 30 Cooperation with the German Cochrane Center Establishment of new research group for syst. reviews at own institution Cooperation with authors from primary studies 9 Expansion of international cooperations 8 Strengthening of research group for syst. reviews at own institution 7 New external, national cooperation 6 Cooperation with Cochrane Methodological Group
20 Relevance of the funding activity for the personal career of project leaders/ review authors: High importance for scientific career in general Establishment of international cooperations Authors achieve national and international reputation Significant impact on expertise in systematic review methodology in work group Implementation of research infrastructures und promotion of young scientists at institutions of the review authors (e.g. EBM-working group, young scientists group, master thesis, PhD thesis, Habilitation, publications, professorship) Funding highly contributes to awareness and acceptance of evidence-based medicine in Germany Contribution of German scientists to the international entities of the Cochrane Collaboration
21 Thank you for your attention! Further information:
22
23 Results from funded systematic reviews had an impact on national and international (S3-) guidelines Haematology/ Oncology (many) Psychiatry (some) Surgery General medicine/ Pain therapy Neurology Rehabilitation after neurological diseases Nursing care
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