The decline of academic medicine

Abstract

In his Viewpoint,1Sheridan DJ Reversing the decline of academic medicine in Europe.Lancet. 2006; 367: 1698-1701Summary Full Text Full Text PDF PubMed Scopus (55) Google Scholar Desmond Sheridan states that the bureaucracy of drug regulation and market access across Europe is more varied and complex than in the USA, making Europe less attractive for research investment. This is not only true for industry, but even more so for academic clinical research.The European Clinical Trials Directive,2EU Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.http://europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_136/l_13620040430en00340057.pdfGoogle Scholar which was driven by the European Commission Enterprise Directorate General to harmonise and simplify European clinical research, has been more a hindrance than a help to academic research by ignoring the academic environment and by allowing member states too great a margin for interpretation. The conduct of many research projects, monocentric as well as multicentric, is not possible any more. A further directive3Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.http://pharmacos.eudra.org/F2/eudralex/vol-1/DIR_2005_28/DIR_2005_28_EN.pdfGoogle Scholar will possibly allow implementation of specific regulations for non-commercial trials. But substantial damage has already been done.Several initiatives to “revitalise” European academic research have been established over the past 2 years, among those the Vienna Initiative to Save European Academic Research (VISEAR),4Druml C Singer EA Wolzt M Report of the 1st meeting of the Vienna Initiative to Save European Academic Research (VISEAR).Wien Klin Wochenschr. 2006; 118: 1-12PubMed Google Scholar which concentrates on issues such as the definition of sponsorship in clinical trials, the heterogeneous ethical review system in Europe, and research in emergency medicine.European research is still dependent on US databases and scientific assessment: as long as the European Clinical Trials Database (EudraCT) is not publicly accessible and European scientific output is measured by a non-public US enterprise (Institute for Scientific Information), European autonomy and scientific excellence will hardly develop. European research needs to be more independent and self-confident to reverse its decline.We declare that we have no conflict of interest. In his Viewpoint,1Sheridan DJ Reversing the decline of academic medicine in Europe.Lancet. 2006; 367: 1698-1701Summary Full Text Full Text PDF PubMed Scopus (55) Google Scholar Desmond Sheridan states that the bureaucracy of drug regulation and market access across Europe is more varied and complex than in the USA, making Europe less attractive for research investment. This is not only true for industry, but even more so for academic clinical research. The European Clinical Trials Directive,2EU Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.http://europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_136/l_13620040430en00340057.pdfGoogle Scholar which was driven by the European Commission Enterprise Directorate General to harmonise and simplify European clinical research, has been more a hindrance than a help to academic research by ignoring the academic environment and by allowing member states too great a margin for interpretation. The conduct of many research projects, monocentric as well as multicentric, is not possible any more. A further directive3Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.http://pharmacos.eudra.org/F2/eudralex/vol-1/DIR_2005_28/DIR_2005_28_EN.pdfGoogle Scholar will possibly allow implementation of specific regulations for non-commercial trials. But substantial damage has already been done. Several initiatives to “revitalise” European academic research have been established over the past 2 years, among those the Vienna Initiative to Save European Academic Research (VISEAR),4Druml C Singer EA Wolzt M Report of the 1st meeting of the Vienna Initiative to Save European Academic Research (VISEAR).Wien Klin Wochenschr. 2006; 118: 1-12PubMed Google Scholar which concentrates on issues such as the definition of sponsorship in clinical trials, the heterogeneous ethical review system in Europe, and research in emergency medicine. European research is still dependent on US databases and scientific assessment: as long as the European Clinical Trials Database (EudraCT) is not publicly accessible and European scientific output is measured by a non-public US enterprise (Institute for Scientific Information), European autonomy and scientific excellence will hardly develop. European research needs to be more independent and self-confident to reverse its decline. We declare that we have no conflict of interest.