Report of the 1st meeting of the "Vienna Initiative to Save European Academic Research (VISAER)"

Abstract

The European Directive 2001/20/EC ("Clinical Trials Directive") was aimed at simplifying and harmonising European clinical research. The directive's attempt represents an important step because many European Member States lack national laws that specifically address details of research, but the goal has been only partly achieved. For academic investigators doing national or multi-national research the new European law and the requirements following its implementation are likely to have the opposite effect. Some areas seem to be of particular concern: trial sponsorship, the ethical review process, the participation of patients who are temporarily not able to consent in clinical trials, in particular the informed consent process, an accepted European registry for all clinical trials, insurance and pharmacovigilance. Furthermore there are fundamental problems of the conduct of clinical trials that could have been foreseen at the time of implementation of the new law, which are impeding academic basic clinical research. The bureaucratic burden for academic investigators has tremendously increased without representing any contribution to patients' safety or to the scientific value of research. Furthermore some large European academic trials cannot be conducted anymore due to the new regulations. This result in a reduction in the number of trials and additionally in a reduction in the number of patients enrolled in a study. European research and thus European patients will suffer from the loss of potential benefits of research. The Vienna Initiative to Save European Academic Research (VISEAR) brings together leading stakeholders from academic research groups and interested parties from industry, international organisations and regulatory authorities to focus on the issues of concern regarding the organisational and funding of academic clinical research in order to improve the development and use of medicines in Europe. The first step of the initiative was a meeting held on May 30, 2005 in Vienna. The resumés of the six parallel working groups are presented in this supplement of the Wiener Klinische Wochenschrift, a position paper with recommendations in relation to the EU Clinical Trials Directive and medical research involving incapacitated adults has been published separately.