New clinical data capture technologies deliver great benefits in helping sponsors meet clinical trial objectives. But because they don’t communicate with each other, they introduce complexities for study teams who need up-to-date access to clinical trial progress and risks. Here, Brion Regan, ERT’s Trial Oversight Product Manager, discusses how today’s improved trial oversight solutions deliver greater visibility into trial data for actionable insights and improved trial efficiencies.
What are some of the challenges sponsors and CROs currently face when trying to manage trial performance?
BR: Some of the key challenges have to do with the number of disparate data systems that are being used across the industry. This has resulted from protocol complexity and, quite frankly, the adoption of new and disruptive technologies that are capturing trial endpoints. Today’s trials collect an average of 12 endpoints, and most use five to seven different data capture systems. These systems don’t ‘talk’ to each other, so aggregating disparate data becomes a huge challenge.
How can sponsors and CROs use technology to overcome these challenges?
BR: A lot of sponsors and CROs today are looking for platform solutions that can help them aggregate data. I like to re-appropriate the word CTMS (Clinical Trial Management System). In the past, a CTMS was a very transactional system. It required a lot of manual data entry. And as a result, what we’re looking at now is the need for a new type of CTMS, a Connected Trial Management System, that can integrate these data sources and provide insights to operational teams – both on the sponsor side and with their CRO partners or others who are supporting the trial.
How is this approach different than a typical CTMS?
BR: Sixty-five percent of sponsors and CROs still rely on manual processes and spreadsheets even though they probably have some sort of CTMS in place. What they’re forced to do is extract data from one system, extract other data from different systems, so that ultimately, they’re pulling everything together in spreadsheets and other manual tools in order to get a full-picture view. Advanced trial oversight solutions are different in that they bring together all of the trial data, all in one place, all without a big investment. Whether it’s risk-based monitoring, data-driven enrollment decisions, or other data-driven mechanisms, they have a single place to go for that information. It’s just a much more efficient way to manage things.
How will the trial oversight needs of sponsors and CROs change over the coming years? How can they prepare now to best meet them?
BR: I think both from a process and a technology standpoint, we’re going to see sponsors and CROs start to work more collaboratively together. The recent ICH E6 (R2) addendum, I think, is a great first step in codifying how we should be thinking about clinical trial design, implementation and conduct. Technology is going to be a key enabler for that strategy and that process, because both parties will need access to that data in at least near real-time. In order to prepare for what’s coming, organizations really need to look at their entire process first and find the hidden manual processes – because they’re there. They can overcome these inefficiencies by implementing technology solutions that enable transparency, agility and anticipatory oversight.
Burcu Aldogan is Director, Product Marketing at ERT