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BEST OVERALL ARTICLE - 20TH EDITION

Pregnant Women as a ‘Vulnerable’ Population in The New EU Clinical Trials Regulation: Does This Classification Adequately Consider the Harms Associated with The Exclusion of Pregnant Women from Clinical Research?

Niamh O'Leary McNeice

‘In adopting a precautionary approach to the inclusion of pregnant women in clinical research, the Regulation fails to recognise that one benefit of the inclusion of this population in clinical research is the avoidance of the harms associated with their exclusion.’

In this article, Niamh O’Leary McNeice critically analyses the new Clinical Trials Regulation, Regulation EU No 536/2014, outlining the detrimental effects associated with both the exclusion and inclusion of pregnant women from clinical trial participation.

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