A key pillar in the COVID-19 battle is the rapid development of a safe and effective vaccine. As vaccine R&D shifted into gear and then accelerated throughout 2020, with a rapidly growing number of candidates, platforms and manufacturers, it appeared that a bottleneck in this race could actually be the ability to enroll participants. With decades of software development and deployment experience, Oracle saw an immediate opportunity to help address key immediate needs on a global scale.
The company built a pandemic response system for the greater good of the world. This platform, provided at no cost, put four capabilities in place to reach large numbers of people easily and quickly, bringing new insights to government scientists and officials:
- A volunteer registry for clinical sites to consider, as part of the US Government’s “Operation Warp Speed” vaccine clinical trials
- Population monitoring and screening
- Diagnostic Management
- Therapy efficacy tracking
This new system, in support of NIH’s Coronavirus Prevention Network (CoVPN), is well on its way to reaching its goal of registering one million volunteers for large-scale testing of vaccines.
A sense of urgency and long hours: Deploying new systems
As the pandemic took hold, sponsors needed COVID-dedicated EDC hardware up and running as quickly as possible. James Streeter, Global Vice President of Life Sciences Product Strategy at Oracle Health Sciences, explained how deploying a CTMS or an EDC normally involves building tools and reviewing it with different groups of experts. “Each review period can take a week or more.” Then there are reviews of revisions and user acceptance testing. “We were finding that people were spread too thin and dividing their time across trials.” Approvals lagged, said Streeter.
During COVID, instead of waiting for 5-10 people to conduct reviews, Oracle saw that number go down to one or two. Critically, the sponsor’s reviewers were also allocated the time to prioritize just those studies, resulting in 1-2-day turnaround. Oracle delivered their Clinical One RTSM system for several sponsors in 10-14 days. With an all-hands-on-deck approach, breaking down silos and improving collaboration was key to reducing setup time.
Managing change and risk: Larger gains over the horizon
The pandemic also presented Oracle with challenges around deploying their technology for COVID-specific trials. When a sponsor was already using a primary EDC or RTSM system, they weren’t willing to shift away from those core processes, even if there was a new system that offered speed gains. Sponsors perceived the risk as being too high to try a new core system, given the potential downstream data effects and how users engage with those systems. Other systems, however, were ripe for immediate changes, because study coordinators simply couldn’t access sites or patients. New tools were essential.
How can the industry realized larger gains with new core technology solutions? Data standards solve some of these issues, says Streeter, but change is now so rapid that standards can be quickly outdated. Systems need to deal with higher levels of complexity. “I think that’s where AI and machine learning come into play, in a new look at how we manage data through not having everything standardized. With unstructured data, you need to be able to process it and figure out based on what’s in there, when it’s not predefined.”
Streeter sees major evolution just over the horizon. “Future trials are implementing new solutions. The leaps are happening in the next round of work.” Progress is being balanced with sponsors’ desire for tried-and-true solutions. “If you’re a large pharma company, with hundreds of trials running and tens of thousands of people using your CTMS, you’re not going to change that in one week. That’s impossible. It takes time.” Future trials that use more tech solutions, explains Streeter, are also more insulated against risk of disruption from future COVID spikes.
Competition and collaboration around DCT
CROs are putting groups together so that sponsors don’t have to contract with separate vendors for a range of digital services. This helps to connect processes and workflow so that bigger changes can happen at the same time – systems talk to each other, and there’s one focal point for the sponsor to turn to for help.
This knowledge and workforce can help CROs enable more comprehensive decentralized trials, explains Streeter. “It’s hard. It’s expensive. And the pharmas don’t have the resources to do it but the CROs have the expertise. I think this a second calling for CROs. As we move to RBM and reduce time, this is where they pick up the other side. It’s just as much work to do these things and manage these digital devices and the patients directly. But the value is high. It’s a different flavor of work and they’re good at it.”
Realizing new potential
Streeter sees the COVID era as a lesson that the CROs and tech companies can work together in delivering real DCT. “We are at a pivot point that we can make it happen. There is competition between ACRO members, but in the end, we are the ones that can make trials decentralized and make it work, collaborate effectively with regulatory agencies to mitigate risks and change the industry.”
James Streeter is Global Vice President of Life Sciences Product Strategy at Oracle Health Sciences
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