Gehring M, et al. – Applications to run clinical trials in Europe fell 25% between 2007 and 2011. Costs, speed of approvals and shortcomings of European Clinical Trial Directive are commonly invoked to explain this unsatisfactory performance. However, no hard evidence is available on the actual weight of these factors or has it been previously investigated whether other criteria may also impact clinical trial site selection. Investigator–dependent factors and ease of approval dominate trial site selection, while costs appear less important. Fostering competitiveness of European clinical research may not require additional government spending/incentives. Rather, harmonisation of approval processes, greater visibility of centres of excellence and reduction of ‘hidden’ indirect costs, may bring significantly more clinical trials to Europe.
Giuseppe Ambrosio (12/14/2013) comments:
Our study shows that administrative burden and unhelpful bureaucratic barriers are key deterrents to running clinical trials in Europe….. 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, our study found…….We also 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 has led us 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!
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