Glossary of Terms (Under Development)

The Glossary of Terms is currently under development. Our working group has identified confusing and overlapping terminology across regions and research settings (for example, proxy-reported outcome measures vs. patient-reported outcome measures, endpoints vs. outcomes) that require harmonization. The glossary aims to build shared understanding and alignment among trialists, academics, families, and regulators. Key and conflicting terminology will continue to be refined through ongoing collaborative work.

As a starting reference, see the FDA Patient-Focused Drug Development Glossary, which provides foundational regulatory definitions.