COVID-19 has forced a reckoning in how we conduct all aspects of our lives, and clinical trials are no exception. Patient safety is the foundational principle of any trial, and suddenly we have a situation where having patients come into clinical sites for their scheduled visits poses a significant risk to their health and well being. Vital data on the patient’s experience in the trial would typically be gathered during these visits, giving essential insight into the safety and effectiveness of treatments. We now must quickly determine how this data might instead be captured in the safety of the patient’s own home.
Medidata is a member of the The Critical Path Institute ePRO and PRO Consortiums—pre-competitive, collaborative groups of eCOA providers and sponsors who work together to advance the science of electronic data capture. Today we released our joint assessment and guidance for those using eCOA in clinical trials.