Commission Consults On New Risk-Proportionate Approaches Under EU Clinical Trials Regulation
This article was originally published in SRA
The European Commission is inviting stakeholder feedback on recommendations to help implement several key aspects of the new EU Clinical Trials Regulation, including how to apply a risk proportionate approach for the design and conduct of trials, and how to present a summary of clinical trial results to laypersons1.
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The European pharmaceutical industry trade group, EFPIA, is concerned about new requirements proposed in a draft European Commission guideline about how sponsors should prepare and test information materials used for obtaining informed consent from minors participating in clinical trials. It has, however, welcomed proposed changes on the use of a “staggered approach” to recruiting minors into trials.
Pharmaceutical companies say that more clarification is needed on a European Commission proposal that offers a revised definition for investigational medicinal products and deals with the use of auxiliary medicinal products in clinical trials.
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.”