TF 1 REGULATORY AFFAIRS:
The objective was to open an informal dialogue between the ESC, European regulatory experts and the Industry for a better understanding of regulations driving CV drugs registration and to facilitate clinical research and development.
Regulatory workshops were organised yearly with open and informal discussions between academia, industry and EU regulators on a variety of topics in the cardiovascular field (e.g. metabolic syndrome in 2005, with an executive summary
published in the EHJ, January 2006).
TF 2 PATIENT ACCESS AND REIMBURSEMENT:
The objective was to investigate factors limiting patient access to novel medical technologies in Europe. A survey on funding and reimbursement strategies in several European countries through the national cardiac societies was carried out first. A summary
(350 Kb) of the survey results were published in the European Heart Journal in April 2004.
In December 2004 the TF organised a consensus workshop with cardiologists from seven countries, guidelines experts, health technology assessment experts and appraisal bodies. Recommendations for the future included clinical guidelines implementation and evidence base, professional involvement in health technology assessment process, and mechanisms for effective political engagement. A report was published in the European Heart Journal on 13 February 2006.
TASK FORCE 4 CARDIOVASCULAR PREVENTION
The objective was to review the strategy and requirements for the implementation of European-wide guidelines on risk factor management.
The TF carried out an extensive pan European market research
on the use of CV prevention guidelines in primary care and by cardiologists. The survey showed that prevention guidelines need to be simpler and easier to use for physicians. The survey also highlighted the need for simple and easy to use risk calculators which take into account the synergistic effects of multiple risk factors.
The TF contributed to the development of HeartScore, based on the SCORE risk charts of the European Guidelines on CVD Prevention.
TASK FORCE 5 CLINICAL RESEARCH IN EUROPE
The objective was to formulate strategies for the promotion and development of CV research in Europe and to act in close collaboration with the European Affairs Committee of the ESC.
The TF focused on 3 areas:
1. Research as a career: ie training, education, experience, recognition
2. Funding of research: evaluation of private and public funding sources
3. Regulatory barriers ie the Clinical Trials Directive and other...
The TF organised a symposium webcast on the Future of Clinical Research in Europe at the ESC annual meeting 2005 in Stockholm. For the first time senior leaders from industry, academia and European Commission discussed the impediments to clinical research in Europe and options for addressing these.