The European Commission is inviting feedback from stakeholders on how the Clinical Trials Directive (Directive 2001/20/EC) might be improved.
The commission wants to know whether the scope of such community-wide authorization procedures should be optional, with the choice being left to the sponsor. Also, it asks whether such procedures should cover all clinical trials preformed in the EU or whether they should be limited to only some clinical trials (for example multinational trials).
Stakeholders are asked to submit feedback on which option is preferable and on the practical and legal issues that would have to be considered if they were to be adopted.
While ethical issues clearly fall within the remit of member states and would remain there, the commission has several suggestions to ensure better co-operation and exchange among national ethics committees to improve the ethical review of clinical trials.
The consultation document contains several examples of inconsistencies in the current application of the directive in member states.
For example, there are different interpretations of what could be considered a substantial amendment; this has resulted in a situation whereby the company regards something as a substantial change more often than it actually should in order to avoid problems of non-compliance.
Also, problems relating to the reporting of suspected unexpected serious adverse reactions (SUSARs) have led to multiple reporting of the same SUSAR, lack of reporting and unreliability of community data on SUSARs. Moreover, the number of SUSARs received differs disproportionately among some member states.
The consultation document builds on the findings and recommendations of an EU-funded study – the Impact on Clinical Research of European Legislation (ICREL) – that was issued earlier this year. The ICREL project was initiated in January 2008 and it measured the impact of the directive on four key stakeholder groups – commercial and non-commercial clinical trials sponsors, competent authorities and ethics committees – between 2004 and 2007.
All fine and good and important and timely – but what about enhanced harmonization with, among others, the United States? First things first perhaps, but the transatlantic issue must be addressed – and sooner rather than later.
The commission wants to know whether the scope of such community-wide authorization procedures should be optional, with the choice being left to the sponsor. Also, it asks whether such procedures should cover all clinical trials preformed in the EU or whether they should be limited to only some clinical trials (for example multinational trials).
Stakeholders are asked to submit feedback on which option is preferable and on the practical and legal issues that would have to be considered if they were to be adopted.
While ethical issues clearly fall within the remit of member states and would remain there, the commission has several suggestions to ensure better co-operation and exchange among national ethics committees to improve the ethical review of clinical trials.
The consultation document contains several examples of inconsistencies in the current application of the directive in member states.
For example, there are different interpretations of what could be considered a substantial amendment; this has resulted in a situation whereby the company regards something as a substantial change more often than it actually should in order to avoid problems of non-compliance.
Also, problems relating to the reporting of suspected unexpected serious adverse reactions (SUSARs) have led to multiple reporting of the same SUSAR, lack of reporting and unreliability of community data on SUSARs. Moreover, the number of SUSARs received differs disproportionately among some member states.
The consultation document builds on the findings and recommendations of an EU-funded study – the Impact on Clinical Research of European Legislation (ICREL) – that was issued earlier this year. The ICREL project was initiated in January 2008 and it measured the impact of the directive on four key stakeholder groups – commercial and non-commercial clinical trials sponsors, competent authorities and ethics committees – between 2004 and 2007.
All fine and good and important and timely – but what about enhanced harmonization with, among others, the United States? First things first perhaps, but the transatlantic issue must be addressed – and sooner rather than later.
