La sottorappresentazione degli anziani nelle sperimentazioni cliniche: possibili soluzioni per una questione ancora radicata

The persistent underrepresentation of older adults in clinical trials con-stitutes a structural paradox in contemporary pharmaceutical research: those who are the primary recipients of medicinal products are often excluded from the evi-dentiary processes underlying their authorization. While widely documented in biomedical literature, its legal implications remain comparatively underexplored. This paper examines the issue from a legal and regulatory perspective, situating age-based exclusion at the intersection of scientific methodology, regulatory de-sign, and fundamental rights protection. It reviews the main causes and conse-quences of underrepresentation and assesses current regulatory responses, in-cluding international soft law, U.S. policies, and the EU framework under Regulation (EU) No 536/2014, highlighting persistent gaps between formal commitments to representativeness and their practical implementation.