Episode description

What trends have you seen in eCOA in 2019?

There’s been a shift in the regulatory landscape over the past year, shaped by an ongoing effort since the launch of 21st Century Cures Act to update patient-centered outcomes. The FDA has also taken on the task of updating guidance to industry published in 2009 on the use of PROs, culminating in the drafting of a fourth new guidance. In early 2020, we can expect to see a new draft guidance reflecting not only updates to technology over the last 10 years, but the clinical research industry’s commitment to finding out how patients feel and function, not just looking at additional life years.

What do you think the future looks like?

Although BYOD isn’t a new idea, the perspectives on it are evolving industry-wide. In the case of ERT, we typically provision devices, but are leading the way by providing multiple avenues to collect patient reported outcomes, including provisioned devices, web portals, and cell phone apps on the patient’s own devices. It’s clear that this method of data collection is now acceptable in the industry. The most interesting aspect is a new trend of multi-modal data collection. This presents some new challenges, but the industry is poised to overcome them and ultimately making it easier for patients to participate in clinical trials.