New European clinical trials directive

Is European research possible?

EDITOR—The concerns expressed by the signatories of the petition to save European research are well founded, and the threats foreseen are in the main real for academic research as well as for smaller biotech and pharmaceutical companies.1 2 At stake in the EU directive on implementing good clinical practice is the possibility of realising a European dimension to clinical research that has the support of public confidence in the research community.

The role and responsibilities of the sponsor in clinical research are key issues. The directive failed to tackle the complexity of this issue in clinical trials. For the sake of patients, the issue of sponsors' responsibilities needs to be settled throughout European research, with or without the support of the directive.

The future health of Europe's citizens depends on the contributions of government and non-government funded research locally, nationally, and in Europe. Europe cannot afford to lose the power and creativity of its academic researchers or the possibilities offered by the smaller research enterprises. The importance of academic research for European health was not well articulated in the debate that resulted in the directive, with the exception of the steadfast engagement of the European Organization for Research and Treatment of Cancer.

European researchers need to decide what they want to save. Do they wish to pool their knowledge and resources in Europe? Or do they prefer that research (as matters now largely stand) be organised and supported primarily nationally? The upshot of the directive may be that national research is strengthened.

The answers to the challenges do not lie in the directive alone. Directive or no directive, the question is how to create a robust European research environment that ensures patient protection and public confidence in all areas of health research.