New Proposal for a Regulation on Clinical Trials


Directive 2001 versus proposed new Regulation: throwing out the baby with the bathwater?

Deregulation under the guise of “simplification”

Dangerous change to the definition of a clinical trial “Low-intervention clinical trials”: caution is needed
“Substantial modification”: wiggle room for scientific misconduct

Member States’ subsidiarity on ethics at risk of being seriously undermined

‘Disappearance’ of ethics committees
A single assessment for all Member States concerned, with very few possibilities to “opt-out” Untenable timelines and “tacit authorisation” by default
Make-believe “ethics assessments” by Member States (Part II): more or less limited to informed consent, and restricted to “own territory”

A revision offering major opportunities to improve healthcare

Requiring comparative clinical trials against the ‘best current proven intervention’ Improving citizens’ access to information
Reporting of adverse drug reactions: do not let ‘the fox guard the henhouse’

To conclude: several major improvements are needed 


Downloand full report

Attachment: en_clinicaltrials_analysis_final.pdf