COVID-19: A Wakeup Call For Clinical Trial Monitoring

Clinical trials have two key goals: to prove the safety and efficacy of new therapeutics. Their success rests on the accurate collection, monitoring, and analysis of data. While today’s data collection is increasingly electronic, monitoring itself still largely occurs onsite, with monitors verifying source data by physically comparing the electronic data capture with the data in a patient’s medical history.

The recent COVID-19 virus highlights the vital importance of changing this model.

With governments everywhere asking people to practice social distancing or shelter in place, monitors are not able to get to sites—and clinical trial subjects aren’t able to get to investigators—creating a challenge for both data collection and monitoring. This threatens to derail trials at all stages, as well as potentially putting trial subjects in harm’s way. It doesn’t have to be this way.