Administered in virtual format, the content offered was in great depth and actually more easily accessible than when attending in-person – no need to find the right conference space or meeting room, just click into the right virtual space and engage immediately! Granted, the social and networking aspect is certainly challenging and the overarching experience – bright lights, high energy, places to go and discussions to attend – wasn’t the normal, but it was a solid „new normal“ for 2021’s sake.
The Clinical Operations track offered was focused on (1) immediate impact of the COVID-19 pandemic on clinical trials, (2) lessons learned from pivoting and working hard to „keep the lights on“ in research over the past 18 months, and (3) lasting innovations stemming from work done during this time.
Here is just a quick tour of key presentations that drive home the theme of technological innovation in the name of patient-centric enablement in clinical trials:
Patients: „Technology-Driven Endpoints for Patient Retention“
This was an excellent presentation addressing trends in clinical trial approach related to study design, decentralized solutions, patient centricity, and increased analytics related to risk managment and trial KPIs, in general. The team spoke to current and future necessity of eConsent, TeleMedicine, eCOA, and a broad range of connectivity inherent to data capture, analysis, and operationalization in this space. The moral of the story is that we’ve only just brushed the surface of what the technological landscape can support in drug, device, and biomedical innovation; doing this responsibly and with agility is the challenge for the future.
Operations: „Technology Changes Needed to Manage Drug Supply for Decentralized Trials“
Agile logistics and decentralized trials, in general, are huge topic areas in the post-COVID life sciences landscape. Here, decentralization was addressed from a patient-centric approach as relates to access and cost efficiency. The presentation team stressed agility in supply chain strategy (i.e. Personalized Distribution, Central Depot to Site, Regional Country Depot to Affiliate) in conjunction with global process support (from SOPs to cross-collaborative SMEs) as the key factors in effective decentralization.
Regulators: „Reliability of Data: What Does It Mean and How Can It Be Accomplished“
When the FDA comes to the table with data quality guidance, it’s a good opportunity to listen! The big message to Sponsors: „Pay attention to what the data is telling you over the course of the study and do something about it.“ The FDA presentors emphasized a shift in thinking, urging Sponsors to to embrace an active data analytical approach related to patient safety and data integrity. Essentially, with the greater availability of technology to support innovation, the expectation is that Sponsors embrace what is available to more quickly, efficiently, and effectively bring drugs/devices to market; With this comes a greater responsibility to ensure (and sustantiate) due diligence at every step along the way.
Overall, the message from the DIA Annual Conference was clear – technology is here, it helped us do great things during a global crisis. Now, let’s take this momentum and put it to even better use into the future. A nobel and exciting call to action!
About the author
Kelly Butler joined fme US as a Consultant in the Consulting Services (Clinical) Team in October 2020 and her bio accounts for her strong Life Sciences expertise. After graduating from the University of Minnesota, Mrs. Butler began work as an Account Executive for UnitedHealthcare and returned to school to pursue her law degree with a focus on healthcare compliance and bioethics. Upon graduation, Mrs. Butler relocated to Raleigh, North Carolina and began her foray into clinical operations specific to R&D in the life sciences space. Recognizing the potential for greater efficiency across clinical operations in leveraging emerging technology, Mrs. Butler shifted her focus to the nexus of biomedical science, technology, and the human element: eClinical Systems. As a Consultant and Customer Success Manager with Veeva Systems, Kelly secured her Vault Platform White Belt Certification through Veeva’s credentialing process, as well as a Privacy Law & Data Protection Professional Certificate from Penn Medicine, University of Pennsylvania Health System.