Humans and AI share the spotlight at SCDM 

By: Bruce Hellman, Chief Patient Officer & Co-Founder, uMotif 

I’m just back from the Society for Clinical Data Managers (SCDM) conference in Baltimore. This year’s theme ‘Hey data, where to next?’ set the stage perfectly for many insightful and exciting discussions about the future of clinical research.

My takeaways?  I’ll share four.

AI is beyond hype and really delivering. 

Today, CROs, vendors, and sponsors are using AI to deliver meaningful improvements to clinical research. They’re using it to speed up documentation and configuration specifications, improve data quality, enable new insights, and reduce mundane work for humans. 

Conference sessions covered a range of live AI use-cases. As Chief Patient Officer for uMotif, one session was particularly interesting to me. It focused on using AI to execute rote and mundane processes, freeing humans to focus on building and strengthening critical relationships with patients, sites, and others involved in studies.

Hearing about how others are using AI today—while successfully balancing risk and ensuring clinical safety—makes me even more excited about the work we’re doing at uMotif, using AI to accelerate our specification and configuration processes and enabling our colleagues more time to focus on trial optimization.

Human centricity is key.

Even with all of the buzz about technology innovation, I was pleased to see that one core purpose underscored all of the sessions and discussions. That was: How can we as an industry help to get  new treatments to patients as quickly and safely as possible? Humans—whether patients or site coordinators—are the users of all of these systems, and there was a strong focus on ensuring that technology serves people and not the other way around.

This was the key theme of the panel I chaired. We explored how technology can enhance the most important relationship in research—the relationship between the patient and their site. Hannah Kulkarni from CRIO and Aneesh Vaze from Philadelphia Research joined me to share how they are using technology to speed up and enhance site visits.

Data managers also need and deserve a human-centric approach to technology.

While many of the sessions were technical in nature, a good number of conversations also focused on how technology can help and support data managers in their day-to-day lives. Once again, the human-centric approach is critical. Data managers wrangle a data universe characterized by ever-increasing volume, velocity, and complexity—including juggling structured and unstructured data from more sources.

Conference participants frequently discussed how this reality makes it difficult  to spot issues early before database lock and rapidly clean data.

This is where new tools that incorporate a person-centered design approach can really help. While patient-centricity is often discussed, I’m asserting that vendors—particularly in eCOA—should also increasingly place the data manager at the center of the design process. This should include designing better ways to ensure cleaner data, providing real-time dashboards with pre-built alerting, and involving data managers in the specification process. This type of data manager-centric approach will deliver faster, more efficient, and ultimately better studies.

Paper is still being used to capture eCOA / ePRO.

Arshad Mohammed from GSK chaired an excellent panel with Zabir Macci from IQVIA, Leigh Bobowski from Pfizer, and Keiran Connolly from Veeva on the eCOA landscape evolution. The session featured audience polling, including a question on the number of studies still using paper to capture eCOA. The results astonished me—and not in a good way—particularly given clear FDA preference for electronic capture to meet the ALCOA principles. Of the 49 responders, 43% said that paper is still used. Through the discussion, this was clarified to mean that paper is frequently used as a backup solution rather than the primary form of data capture.

Paper eCOA capture has many drawbacks. It prevents real-time reporting, can lead to quality issues and questions about data sources, and complicates reconciliation with electronic systems. However, given the prevalence of paper, it’s important that platforms, like uMotif, have a solution for uploading eCOA data into the system, with the source clearly identified.

Conferences like SCDM, which feature industry professionals focused on improving clinical trial processes for the greater good, never fail to energize and spark new ideas. I’m looking forward to more dialog with industry leaders at conferences in the coming weeks and am excited to share future takeaways with you.