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Payer-relevant Endpoints
PRO Strategy
A comprehensive review of available PROs including their respective construct models and recommendations for PRO assessments P Analysis
Identified the shortcomings associated with the which are PRO measures traditionally used in esearch PRO Dossiers (2)
Ambulatory (2019/2020) & Non Ambulatory (2020/2021) Provides background rationale and evidence to support the PRO strategy and evidence for the the use of PROMIS and other PROs in in clinical trials and real-world settings Used to inform external discussions regarding PROs including EMA HTA Parallel Advice Meeting PRO Taskforce
Assembly of an expert taskforce* to provide consensus on on the best analytical approach for PRO analyses PRO SAP & Analysis
Expert-informed statistical analysis plan for PROMIS item bank inclusion in pivotal
trial Patient Caregiver Dyad
An interview survey that identified
perceptions of their experience with and impacts on on overall function
and daily life Needed for psychometric assessment of PROMIS item banks PROMIS Psychometric Assessment Psychometric testing of the PROMIS item banks including longitudinal analysis across a a a a a broad spectrum of patients and assessment of minimally important differences Vignette Utility
Estimate of health state utility values from a a a a societal perspective for a a a a a set of health state utility values to describe granular differences in in the clinical course and progression of in clinical trials *Taskforce
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