Medable eCOA

In patient-centric clinical trials, COAs are essential to understand the impacts of a drug on certain endpoints, for example, whether it is improving or diminishing quality of life and everyday activities that matter to patients. The FDA, signaling the importance of COAs and the need to develop additional ones, has even created specific guidance and pathways for their development and validation. Fortunately, one of the lessons from COVID-19 is that we can be flexible and efficient and conduct a multitude of COAs remotely, with eCOAs. No longer do patients need to come into the clinic for every assessment:

• ClinROs can be measured over a televisit
• PROs can be measured through patient directed surveys on a mobile app
• ObsROs can be measured on mobile apps with care partners assistance at home
• And device data can be used to generate PerfOs