Site Centricity, Connected Data, and AI: 3 Trends From SCOPE Summit To Watch in 2024
Looming site consolidation, new technologies, and the hype surrounding generative AI are forcing the industry to refocus on the fundamentals of clinical research to clear the way for long-term innovation.
Here are three key trends we saw at Summit for Clinical Operations Executives – better known as SCOPE – and how they will impact your clinical development teams in the year ahead:
1. Clinical research sites have more power than ever
An estimated 3,000 clinical research sites have stopped conducting trials since 2019, according to Ken Getz, executive director of the Tufts Center for the Study of Drug Development. The majority of these sites were small, community-based independent centers conducting one or two clinical trials annually. As the investigative site landscape consolidates, sponsors will have to compete for the highest-performing sites and principal investigators. They’ll do this by building stronger site-sponsor relationships and streamlining their tech stacks to reduce site burden.
For example, Merck’s Director of Global Clinical Trials Natalie Blake shared that the company is “moving away from process-driven site-sponsor relationships toward a consultative and dynamic mindset.” To support this shift, Merck implemented a Clinical Site Partnership program. The company has partnered with 30+ global sites, in part, to leverage key feedback for clinical trial technology strategies that work for site staff, sponsors, and patients. Since implementing this program, Merck has been able to garner feedback on over a dozen initiatives in areas such as clinical supplies and data management.
2. The industry is moving away from DCT labels towards patient optionality
There was a lot of chatter, and even a panel discussion, questioning if DCTs are “dead.” Many companies seem to be evolving their terminology. For example, Pfizer’s Senior Vice President of Clinical Development and Operations Rob Goodwin shared that the company calls its clinical trial strategy approach “Care Everywhere.”
Labels like DCTs can often distract from our ultimate goals of improving patient optionality and access. To truly put patients first in clinical trials, broaden your scope to think more about how trial data is collected and shared rather than where trials are conducted. Data interoperability – not decentralization – sets the foundation for a connected, patient-centered clinical trial.
3. Generative AI isn’t the answer to smarter clinical trials… yet
The tone at SCOPE around generative AI was undeniably optimistic. Many top biopharmas discussed their investment in AI infrastructure, like knowledge graphs that organize data points from multiple sources and find connections between them. However, our current knowledge of AI still lags far behind the hype surrounding it. One day, we may see protocols largely created by AI rather than written exclusively by humans. But we’re still in the very early stages of figuring out how to harness AI’s true potential.
Instead, focus on building the data foundation for AI. We can innovate responsibly by balancing investment with proven returns and long-term potential. Many companies are heading in the right direction by automating processes like TMF document classification and protocol assessment scheduling. But, presenters stressed that a strong foundation of clean data should still be at the core of each clinical trial. Remember: cleaning data is a fundamental requirement for future AI use cases, not an AI use case in itself.