Demonstrating the need for ePRO: COVID-19 makes the point

Outbreaks in recent years, such as SARS, avian flu, and Ebola, in retrospect seem to have been a testing ground for the current COVID-19 lockdown.

During those outbreaks, study sponsors experienced the challenges of managing clinical trials in traditional ways, and many therefore pushed forward their adoption of eClinical platforms to ensure they could still manage their trials in remote locations, while reducing the impact on their project timelines, ensuring their investigators and monitors remained safe, and enabling their subjects to demonstrate compliance.

Why ePRO works so well in lockdown  

The traditional process of conducting clinical trials involves face-to-face interaction with subjects, which is proving difficult in the current lockdown. Subjects still need to make visits to clinical study sites to meet with healthcare professionals however the need to take part in lengthy reviews of their paper diaries is removed when using ePRO. By adopting ePRO for subject reporting, it is possible to significantly reduce the need for close face-to-face interaction with subjects and speed up the collection of quality data. In addition study sponsors benefit from a huge reduction in the travel of the onsite monitoring teams as ePRO increases the ability to conduct remote study monitoring.

With ePRO, the reporting and audit trail is also improved, since it is possible to prove that patients respond daily in accordance with the study Protocol (not possible with manual records).

BYOD (Bring your own device) is another consideration. It is recognised by Scimcon that BYOD reduces hardware challenges associated with the shipment of devices, but more importantly in the current situation removing the need for devices to be passed from human to human both within the logistics departments of the vendors and between the investigators and subjects (often ePRO devices are reused between subjects on an individual study). An upcoming post will cover the BYOD topic in more detail,

Moving from paper: better reporting and ALCOA principles

The regulator’s requirements for Accurate, Legible, Contemporaneous, Original and Attributable (ALCOA) data are achievable with ePRO platforms, where it has always proved difficult to remove doubt with paper-based Patient Reported Outcomes. In paper records, it is far more difficult for instance to prove when information was recorded, whereas in eClinical platforms when and by whom data is entered is automatically recorded, giving more accurate insight. Legiblity issues obviously become an issue of the past with ePRO.

The clinical trials community has been debating the benefits of ePRO for many years, and with the advent of COVID-19 where face-to-face interactions need to be limited, its adoption seems prescient. ePRO is the no-brainer product for now and future trials, both on data quality and in order to reduce concerns of unnecessary social interactions. Scimcon has hands-on experience with global clinical trials projects and is proven with ePRO platforms, doing what we do best: serving the science community with our skilled project teams to manage data projects globally.

Read more about ePRO:

https://www.ncbi.nlm.nih.gov/pubmed/25300613  and http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf