Traversing the Last Mile for Regulatory Qualification of Sensor-derived Digital Endpoints Description In this talk, we will outline what we believe to be gaps in the evidentiary requirements framework for regulatory qualification of sensor-derived digital endpoints....
Revealing hidden change through a response shift lens: The role of individualized methods Description This webinar will focus on the role of individualized methods. Using a vignette, the audience will consider changes that people could report when experiencing a...
Description Reliability is a key property that needs to be assessed with all PROs, as outlined in regulatory guidance documents as well as psychometric best practice. That is, to what extent are my PRO scores reproducible or consistent across facets of interest, e.g....
Description Within current literature and practice, the category of patient-reported outcome (PRO) measures has been expanded into the broader category of clinical outcome assessments (COAs), which includes the subcategory of PRO, as well as clinician-reported outcome...
Description Healthcare resources are finite and priority decisions have to be made by regulatory bodies to align the need, clinical effectiveness, and cost-effectiveness of healthcare interventions and services. Cost-utility analysis (a type of cost-effectiveness...
Description Exposure-response (E-R) analysis to inform optimal dose in early clinical development of oncology products has traditionally relied on adverse event-based clinician-reported Common Terminology Criteria for Adverse Events. As part of a broader effort to...
