Spend some time in the world of clinical research and you’ll observe two divergent themes on how to deliver trial activities:
- Paper and in-person visits
- Technology and innovation in a decentralized / remote environment
It’s the timeless debate of classic vs. modern. Staying with what’s familiar vs. exploring what’s new and unknown. Using a music analogy, we’ve got:
- Jimi Hendrix vs. Greta van Fleet
- Johnny Cash vs. Blake Shelton
- Stevie Wonder vs. Lizzo
Add it all up and it feels like “Madness” (Muse).
So, where do we go from here? Who’s right?
The answer: both camps are correct. The challenge for our industry is to move from an “either/or” mindset to a “both/and” way of thinking.
An Eye-Opening Site Visit
In December 2022, a teammate and I took a visit to a clinical trial site network. While there, we met with one of the lead CRCs and she described her experience managing 13 different clinical trials at a time (a number that impressed in and of itself). She talked about the vast number of systems she had to use (including five different EDCs) to support these trials and how her team conducted most of the data collection on paper before transcribing it into the corresponding solution after the in-person visit. They created a new role on their team and hired a full-time employee just to do the data transcription.
Each of the systems required a different login (she created an elaborate browser bookmark management system to keep all of the URLs and username/password combinations straight), none of them shared data, and most of the time she and her team didn’t have much advance visibility into how visit data should be collected – which led to them creating their own eCRFs based on the EDC manuals they received for training. They maintained binders of all paper forms used in the case of audits and monitoring visits.
Some of the reasons they relied so heavily on paper was because of a rural patient population where many of the subjects didn’t have access to internet. Site visits contained many activities in a short period of time and it was easier, more efficient and more reliable to document things on paper in real time and then transcribe later. The CRC liked the tools that we had in our platform, but she said she wouldn’t use them if they became just another URL to remember (and we didn’t blame her!).
The Path Forward
It’s safe to say there are things technology can do which expand the reach and efficiency of clinical trial activities, scenarios that would be unachievable without remote capabilities; at the same time, there are valid reasons why paper is still so commonly embraced as a solution for clinical trial sites. The influx of disconnected digital solutions has only made it harder on sites and patients, who now must navigate multiple URLs or apps with unique logins for each system.
To make progress and better serve our end users:
- Tech vendors need to:
- Provide workflows that can accommodate both paper / in-person and digital/remote encounters
- Collaborate and agree upon a standard way of integrating disparate systems (CRISI is leading the way)
- Research teams need to:
- Start designing protocols, consent forms, and assessment tools with technological capabilities and end users (sites, patients, caregivers, etc.) in mind
- Think about how to maximize the capability of digital while maintaining paper as an alternative
- Encourage and support sites (on an ongoing basis) to effectively use the technology
Focusing on solutions that give end users a choice in how to complete their activities will empower users to take control of their trial experience. Working together to provide reusable integrations built on standards will increase the usability of digital tools and lead to a better return on investment for study teams.
Queue War’s “Why Can’t We Be Friends” for the win.
