Updated November 10, 2020
Experts on our Patient-Centered Outcomes Assessment (PCOA) team collaborated to create this research best-practices document to help research teams mitigate some of the impacts of COVID-19 on the collection and use of clinical outcome assessment (COA) data. They drew on current FDA recommendations for patient-focused drug development (PFDD) and other more emergent regulatory commentaries specific to COVID-19, as well as guidance from sources outside the US such as the MHRA and HRA in the UK and, more broadly for the EU, the EMA.
This document provides guidance on determining go/no go decisions, understanding potential threats to the validity of the research, and alternative data-collection methods for capturing patient experience data.
Reach out to our team using the form on this page to learn more about about how we can partner with you in patient experience data collection.
See Additional Ways We Are Involved in COVID-19 Research