Yet Another Delay For Landmark EU Clinical Trial Rules – Now To 2019
The go-live date for the coming EU Clinical Trial Regulation and accompanying portal and database is being postponed again. The delay will also impact the EMA’s schedule for training drug sponsors and European authorities in how to use the portal and database.
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The European pharmaceutical trade group EFPIA says an “initial pilot” program should be launched to test the value and impact of the draft EU guideline on presenting lay summaries of clinical trial results. The group believes that the guideline should be reviewed following the pilot, as complying with it in its current form would result in companies shelling out “significant additional resources.”
The pharmaceutical industry and other stakeholders are calling for practical advice on how the new EU guideline on using a risk-proportionate approach to clinical trials will be implemented in practice. Clarity has been sought on several topics, especially on new requirements such as preparing a risk assessment and mitigation plan as part of a trial protocol.
“Thousands and thousands of people” will be using the EU clinical trials portal and database after it goes live late next year and the European Medicines Agency plans to “invest a lot” this year in teaching trial sponsors and EU member state authorities how to use the new system. The EMA is also still working on ironing out the tricky areas of user management and how to transition legacy trials.