Clinical Trials: Are We Any Closer To Solving The Rubik's Cube?

By Richard Young, Vice President, Vault CDMS

We need to examine the total experience in clinical trials—of users, not just data—if we want to achieve true operational excellence.

Clinical trials were one-dimensional when I began my data management career more than 20 years ago. Decisions were made in a linear fashion. Database lock was treated as sacred and required multiple permissions forms to reverse. The phrase ‘data veracity’ didn’t exist in our vocabulary because every data point was born equal.

Today, we’re in an era of platform, bucket, and umbrella studies. Companies are exploring trials with an immense focus on individual visits and data points, running studies that require amendments almost after every patient visit. As Tanya du Plessis, chief data strategist and solutions officer at Bioforum, notes, “We’ve gone from linear to almost circular [in data management]. It’s hard to determine where one step starts and the other ends, and that’s not even accounting for the volume or veracity of data”.