A patient-reported outcome (PRO) measure (sometimes known as a PROM) is the tool or instrument used to collect PRO data. These can include:
At DRG Abacus, our dedicated Clinical Outcomes Assessment (COA) team have extensive experience in the design, validation, and implementation of PRO measures to support clinical trial endpoints. Our methodological approach reflects the Food and Drug Administration (FDA) PRO guidance to industry and learnings from European Medicines Agency (EMA) reflection papers.
The first step in our approach is to help you identify and review existing PROs in line with FDA and EMA regulatory guidance to understand:
Our COA experts can design qualitative, quantitative, and mixed methods research studies to generate evidence for validity or support the full development and validation of new PROs:
Read our case study to find out more about our expertise in developing a patient-centric clinical development programme for a pharma clientDownload
Read our case study to find out more about our expertise in identifying a suitable PRO strategyDownload