As part of PCT TV at Partnerships in Clinical Trials Europe, we spoke to Dr MaryAnne Rizk, Global Vice President of Biopharma Partnerships at clinical data company Oracle, about how she sees data impacting clinical trials and the challenges that still need to be overcome.
Watch the full exclusive interview or read the key takeaways below.
What are the biggest challenges facing clinical trials today?
'I see two large challenges that relate to the proliferation of data. Number one; there's an increase in the amount of data in clinical trials today between data generated by clinicians, real-world evidence being a critical part now of the experience surrounding a patient-centric clinical trial, mobile data and genomic data. So you've got mounds and mounds of data, as well as a huge variety.
The second main issue is being able to drive meaningful use out of that data. How do we extract, aggregate, clean and understand the importance of all that data that we've collected?'
Which technologies do you think will have the biggest impact on clinical trials?
'Years ago we were talking about the Cloud and mobile, and that's allowed us to have improved access to clinical trial data and the volume and variety. Now, really the technology that Oracle has anticipated - being a data company - is understanding how we make sense of all this volume and variety.
It's understood there's about eight billion data points per patient in a clinical trial - that's a lot of data. So in order to be able to aggregate all that data, to be able to automate some of the services that were once very much overdone and repeated by Sponsors and CROs, we took it upon ourselves to release a solution called DMW - Data Management Workbench.
I like to use the term the 'ultimate cleaning machine' because it really allows us to help in the clinical research process to automate redundant processes and really create a single unified platform and a single source of truth for data. No longer are you doing 'data transportation' - moving data from one source to another. [You're] able to holistically look at your EMR data, your mHealth data, your IoT, your genomic data, your EDC data in one location. So we're able to help Sponsors in the race to optimize from source to submission readiness.'
How do you see partnering strategies in clinical trials developing?
'I believe technology is going to be the hub for how Sponsors, whether they're global pharma, emerging biotech or in the MedTech space, are collaborating with CROs and defining these new ways of partnering. Data is by definition creating trust and transparency.'