The cooperating organisations involved in the Rare Cancers Europe initiative and 25 non-commercial and commercial organisations have issued a joint statement on the Proposal for an EU Regulation on Clinical Trials.
We welcome the proposal for a Clinical Trials Regulation released by the European Commission. The Regulation appears to improve the legislation associated with running clinical trials. This will give clinicians and researchers a better framework for developing and testing treatments, to benefit patients across Europe, while maintaining the high standards of patient safety that currently exist in European clinical research. The harmonisation of clinical trials legislation and the streamlining of the application process for starting trials should particularly benefit the set up and running of multi-national trials in Europe.
This statement outlines the areas of agreement within the health and research communities on where the Regulation will improve the research environment. Aspects of the Regulation that could be improved to further support clinical research are also highlighted. As the exact content and nature of the Regulation continue to be debated, we believe that there is opportunity to push for more effective and proportionate approaches to certain aspects of the legislation.
In summary:
- Further clarity is needed on the two category risk based approach proposed in the draft Regulation.
- We welcome efforts to provide greater clarity around the scope of the Regulation. However, it may be possible to refine these definitions further.
- The EU institutions should outline how it would go about creating and implementing the IT systems associated with the Regulation.
- Co-sponsorship is important for many academic trials which are conducted through a partnership between universities and hospitals.
- We welcome the mechanism for involving patients and their representatives on the panel involved in assessing clinical trials.
- Particular aspects of the safety reporting system in the Regulation may require further clarification to give certainty to the staff running trials on what elements they should report on.
- Clarification is needed to ensure that it is clear that sponsors continue to be responsible for determining whether modifications to a clinical trial are substantial and that guidance is clear for making these decisions.
- We would welcome a more detailed outline of the proposed national indemnity scheme, which is of potential interest to the research community.
- Provisions for conducting emergency clinical trials are also welcomed but the requirements for entry into emergency clinical trials should be reviewed to ensure they do not limit patient recruitment.