Sponsored by RTI Health Solutions
The Symposium is free and open to all ISPOR delegates, no pre-registration required.
This symposium will review what is a label claim, what evidence is needed to support the claim, and how to design a conceptual framework and endpoint model for a PRO Evidence Dossier.
In February 2006, FDA published the draft Guidance for Industry on Patient-Reported Measures: Use in Medical Product Development to Support Labeling Claims. In order to obtain a Product Label Claim for a Patient-Reported Outcome (PRO), industry sponsors need to provide evidence that the outcome was measured using a validated instrument in a clinical trial that was properly designed for that purpose.
To meet this objective, it’s important to understand label claim wording and structure. Industry Representatives from PhRMA Health Outcomes Technical Group have been working with FDA to further describe the evidence needed to support labeling claims and the level of documentation required for PRO briefing documents submitted to FDA for review. One piece of that evidence is the Conceptual Framework for Instruments and Endpoint Models for Study Protocols. This workshop will review what is a label claim, what evidence is needed to support the claim, and how to design a conceptual framework and endpoint model for a PRO Evidence Dossier.
1:30 - 1:35
OPENING REMARKS
The speakers will briefly address PRO Label Claims for FDA and the supporting evidence needed to obtain a PRO Product Label Claim. In addition, one of the speakers will describe developing conceptual frameworks and endpoint models for PRO Evidence Dossiers.
Moderator: Sheri Fehnel PhD Global Head, Patient-Reported Outcomes, RTI Health Solutions, Research Triangle Park, NC, USA
1:35 - 1:50
WHAT IS A PRO LABEL CLAIM AND WHAT EVIDENCE DO YOU NEED?
The speaker will discuss PRO label claims and provide examples. The evidence needed to support obtaining a PRO label claim will also be described.
Speaker: Kati Copley-Merriman MS, MBA, Global Head, Outcomes Research and Regulatory Strategy, RTI Health Solutions, Ann Arbor, MI, USA
1:50 – 2:05
PRO EVIDENCE TO SUPPORT LABEL CLAIMS
The speaker will discuss the outline of a PRO Evidence Dossier to support Label Claims and describe the section contents.
Speaker: Julie Chandler PhD, Senior Director, Epidemiology, Merck Research Laboratories, Blue Bell, PA, USA
2:05 – 2:20
CONCEPTUAL FRAMEWORK AND ENDPOINT MODELS TO SUPPORT LABEL CLAIMS
The speaker will discuss the structure and process for developing conceptual frameworks and endpoint models for PRO Evidence Dossiers and provide examples.
Speaker: Diane Wild MS, Director, Patient-Reported Outcomes, Oxford Outcomes, Oxford, UK
2:20 - 2:30
DISCUSSION / Q&A
