European Information Network - Ethics in Medicine and Biotechnology
A project of the European Commission,Quality of Life and Management of Living Resources Programme
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European Information Network - Ethics in Medicine and BiotechnologyA project of the European Commission,Quality of Life and Management of Living Resources Programme |
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| Date: | 19.11.2009, 10:00h to 20.11.2009, 16:15h |
| Location: | Résidence Palace – International Press Centre
Rue de la Loi 155
1040 Brussels
Belgium Brüssel Belgien |
| Keywords: | Health care system/Health policy - Disease - Prolongation of life - Medical ethics - Nursing ethics |
| Details: | There has been an explosion in the size of the older population in Western Europe over the last few decades which is projected to reach a huge proportion with over "one third" of the European population being over 65 by the mid century. This, so-called silver tsunami, will have a major impact on medical research within the European Union. Many clinical studies have traditionally had age cut-offs thus limiting their applicability to these people. Many older patients suffer multiple morbidities which questions the credibility of many clinical trial results with their narrow inclusion and extensive exclusion criteria. First-in-man studies are nearly always carried out in young fit male volunteers who have completely different pharmaco-kinetic and -dynamic characteristics from the older, predominantly female population, many of whom increasingly consume multiple medicaments; all of these reasons question the current approach to drug development for this growing population. In addition, the aging process produces its own specific pathological states and diseases which can only be studied in these populations. The older participant may also be particularly vulnerable in a number of ways which may preclude autonomy and dignity thus limiting inclusion in clinical trials and access to the benefits of medical research. The lack of research data in this population has been of increasing public concern. There has, to date, been little recognition either within medical, regulatory bodies or political fields of the extent this markedly changing demography will have on medical research in general and clinical trials in particular in the twenty-first century. The Geriatric Medicines Working Party of the European Forum for Good Clinical Practice has thus brought together experts in the fields of clinical research, ethics, philosophy, social, patient organisations and pharmaceutical regulatory bodies to explore the issues surrounding the effect of this silver tsunami on drug development and medical research. It is hoped this conference will be of interest, offer guidance to investigators and set the agenda for funding bodies, ethics committees, the pharmaceutical industry and regulators alike, in order to facilitate and promulgate high quality ethical clinical research and drug development for this increasingly important population across the whole of the European Union. |
| Organizer: | The European Forum for Good Clinical Practice (EFGCP) |
| Contact: | Address: EFGCP Secretariat Square de Meeûs Rue de l'Industrie 4 1000 Brussels Belgium Tel: +32 - 2 - 7 32 87 83 Fax: +32 - 2 - 5 03 31 08 Email: conferences@efgcp.be |
| Webpage: | http://www.efgcp.be/Conference_details.asp?id=242&L1=10&L2=1&TimeRef=1 |
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