Current Edition

Policy 0070 Under the Microscope: The Trade-off Between Clinical Trial Transparency and the Risk of Revealing Patient Identities

The last few months have seen a battle build between
the pharma industry and the EMA, following the issue of
new guidance promoting greater transparency in clinical
trial reporting. Specifically, ‘anonymised’ clinical study
reports should now be made centrally available at the time
of marketing authorisation submissions, but risk-averse
manufacturers are digging in their heels. Cathal Gallagher,
Life Sciences consultant for d-Wise, reviews recent
developments and considers how the situation will play out.