Planning Post Trial Access Early: Choosing the Right Pathway Before Trials Close

• Defining post trial access obligations at the trial design stage rather than at close out
• Choosing between open label extension, post trial access, or early access before Phase III completion
• Aligning PTA planning with budget, supply availability, and country level feasibility upfront
• Preventing long term, unsustainable obligations by understanding and documenting what was committed to authorities

Speakers:

Antoine Robert

Global Post-Trial Access Lead

Sanofi