For decades, clinical trials systematically under-enrolled women, elderly patients, racial and ethnic minorities, and people with comorbidities. The consequences became apparent when approved treatments reached diverse patient populations and performed differently than expected, sometimes less effectively, sometimes with unexpected toxicities. The research enterprise was generating answers, but not answers that applied equally to everyone.

ICH E6(R3) addresses this directly through Sub-principle 1.4, a new requirement that participant selection should reflect the intended treatment population. This lesson examines what that principle requires and how it must be balanced with the special protections owed to vulnerable populations.

For decades, clinical trials systematically under-enrolled women, elderly patients, racial and ethnic minorities, and people with comorbidities. The consequences became apparent when approved treatments reached diverse patient populations and performed differently than expected, sometimes less effectively, sometimes with unexpected toxicities. The research enterprise was generating answers, but not answers that applied equally to everyone.

ICH E6(R3) addresses this directly through Sub-principle 1.4, a new requirement that participant selection should reflect the intended treatment population. This lesson examines what that principle requires and how it must be balanced with the special protections owed to vulnerable populations.