This year’s Site Solution Summit, a virtual event, was all about remote monitoring. Here’s what I learned:
1. Remote, or “virtual”, monitoring is here to stay.
Several sponsors and CROs stated that they have modified, or are in process of modifying, their SOPs to enable remote monitoring. Even after the pandemic ends, many sponsors intend to continue incorporating remote monitoring, as a complement to, or in partial replacement of, on-site monitoring. Even before the pandemic, the adoption of risk-based monitoring laid the groundwork for this transition, as sponsors could be more flexible in adopting varied monitoring techniques.
2. Sponsors will utilize site technologies already in place.
Sponsors are willing to respect the workflows and technologies adopted by many sites. While some are considering offering eSource/eRegulatory technologies to their sites, none are planning to mandate that sites already using their own technology platform switch over. Every sponsor and CRO representative that spoke was aware of the trend towards technology adoption by research sites, and willing to work within the remote monitoring capability of that technology. This is in stark contrast to three years ago, when many sponsors were just starting to learn about the trend toward site adoption of eSource.
3. While trials will become more de-centralized, they are still centered around local sites.
Truly direct-to-patient is still a long way off. While a lot of protocols will adopt more at-home options for patients, the vast majority will continue to require local PI oversight. Hybridized trials, involving a combination of in-clinic and remote procedures, is likely the future direction of research.
4. Trials will get more complicated, not less.
Ken Getz, founder & board chair at CISCRP, ended the summit with a great recap of the trends, then pointed out that the increase in the virtual component of clinical trials will make research more, not less, complicated. Hybridized trials mean that some procedures will be done in-clinic while others remotely; sites and mobile research units will have to collaborate to deliver services to the patient; and new logistics for drug delivery and remote procedures have to be implemented. All this complexity could exacerbate the long-running trend towards more complex protocol design and longer timelines to market.
From CRIO’s perspective, these are encouraging trends, with some challenges. We’ve always believed that the key to streamlining clinical research is through great site-centered technology, since sites own the responsiblity of recruiting patients and collecting data. Still, there’s one overarching question, raised by several participants throughout the sessions:
Will all these new technologies work together?
In other industries, it’s not unusual to have a plethora of software options, with integrated workflows enabled by a common communication framework. The clinical research industry already has a standard set of communication protocols, known as CDISC. To date, while many vendors have adopted CDISCS and have API’s of some kind, the industry at this point is nowhere near true inter-operability. But as trials become more complex, more workflows become remote, and sponsor and site technologies flourish, the natural question is whether, when, and how these technologies will begin to communicate with each other seamlessly.
I remain optimistic that the industry will head towards inter-operability. At CRIO, we certainly have our work cut out for us, but we’re committed to inter-operability and will be investing towards that goal over the coming years.