European Clinical Research Needs Harmonization of Approval Processes and Disease Management Networks, Survey Finds
Government incentives and cost of trials not critical factors
The SAT-EU study group, an independent non-profit collaborative initiative, supported by the European Forum for Good Clinical Practice (EFGCP) and several other trade and not-for profit organisations, today announced the results of a survey of 458 professionals representing clinical research organizations (CROs), academic clinical trial units (CTUs), and the biopharmaceutical industry in 34 countries.
Research published in the online British Medical Journal BMJ Open found that administrative burdens and unhelpful bureaucratic barriers are key deterrents to running clinical trials in Europe. In contrast, the cost of running trials, and particularly government financial/tax incentives are considered to be of significantly lower importance, the study also indicates. The announcement comes on the backdrop of statistics showing that applications to run clinical trials in Europe fell 25% between 2007-2011, resulting in much public policy discussion on the need to foster Europe’s role in medical research.
Europe’s Pharmaceutical industry invests € 30bn on research and development each year. It is the sector with the continent’s highest R&D/Sales ratio in Europe, and is responsible for 25% of Europe’s high tech exports. "Having an attractive market for the conduct of clinical trials in Europe is essential to the development of the biotech industry in the region. Europe needs growth, and clinical research can play its part in directly stimulating economic activity while simultaneously boosting European innovation," explained Nathalie Moll, Secretary General of EuropaBio in Brussels.
"Speed to trial start is critical," commented Giuseppe Ambrosio, Professor of Cardiology at the University of Perugia, Italy, and co-author of the study. "What survey participants want is less national variability in clinical trial applications, streamlined competent authority and ethics approvals and simplified hospital contracting (such as via national or pan-European templates). Our work suggests that a stronger pan-European element in the trial application process will greatly benefit European Clinical Research by bringing more studies to Europe, encouraging additional investments, and fostering collaboration at a high level among hospitals Europe-wide," he added.
"This study seems to indicate that fostering competitiveness of European clinical research may not require additional government spending/incentives. Rather, harmonization of approval processes, greater visibility of centres of excellence, and reduction of "hidden" indirect costs, may bring significantly more clinical trials to Europe," commented Ingrid Klingmann, Chairman of the European Forum for Good Clinical Practice (EFGCP).
The SAT-EU Study also looked beyond bureaucratic impediments, pointing to other ways in which European research can become more competitive. Facilitating access to pan-European disease area experts and to centres of excellence via a greater number of disease-management networks would help steer clinical trials towards optimal patient recruitment, the study found. Similarly, greater visibility of clinical trial units through dedicated websites was ranked as highly desirable by survey participants.
The research paper found considerable variability in the perceived receptivity of countries to undertake clinical trials, with Germany, United Kingdom, and the Netherlands consistently rated the best trial markets. This led the authors to suggest the usefulness of a best practice audit of provisions governing clinical trials in these countries. "The case for action rests on the realization that evidence-based policy is indeed possible in this arena. Learning from what is working successfully will facilitate the road to creating a more welcoming environment for clinical research in Europe," the authors concluded.
About the Survey
The SAT-EU survey sought to systematically assess factors impacting European clinical trial site selection, exploring 19 factors across investigator-, hospital-, and environment-driven criteria, and costs. It also surveyed perceptions of the European trial environment, and sought feedback as to desired improvements. The web-based survey attracted responses from 458 professionals representing clinical research organizations (CROs), academic clinical trial units (CTUs), and the biopharmaceutical industry in 34 countries.
The survey was executed in collaboration with industry and clinical trial associations including the European Forum for Good Clinical Practice (EFGCP), Applied Clinical Trials (ACT), The Drug Information Association (DIA) ,Pharma IQ, the European Federation of Pharmaceutical Industry Associations (EFPIA), and the European Biotech Industry Association (EuropaBio).
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Media Contacts for the SAT-EU Study Group: Europe - Nick Miles
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Media Contacts for the European Forum for Good Clinical Practice (EFGCP)
Ingrid Klingmann, MD, PhD, Chairman
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