18 Nov Are Any Data in Clinical Trials Better than No Data At All?

By Scottie Kern, Applied Clinical Trials

The expectation set on the clinical trial participant around the accurate and timely collection of data that details that participant’s perspective and experience during a clinical trial demands careful consideration. Electronic methods of capture of clinical endpoint data are becoming increasingly dominant, and yet it’s notable that in some respects the industry continues to critique electronic methods in a way paper-based methods are not.

One such dynamic is the persistent anxiety around how technical issues can arise with electronic systems and the consequences of them occurring. They do arise—to pretend otherwise is an exercise in futility—but the setup of any clinical trial should incorporate a thorough risk analysis that extends to factoring in what happens when any tools used to collect data are, for whatever reason, unavailable or unable to be used. To that end, paper could be considered a reasonably robust technology itself, but the issues with paper pertain to how it’s used. Key facets of electronic data capture such as accuracy, contemporaneousness, and the associated enhancement of quality can be compromised if the primary mode of data capture isn’t employed consistently throughout a trial, so backup strategies are planned for and occasionally employed. Read more…