Back in November, Medrio dispatched a handful of representatives to MAGI’s Clinical Research Conference in San Francisco. The conference was full of important players in the clinical research industry, who shared fascinating observations, predictions, best practices, and more over the course of dozens of enlightening sessions. We followed up our trip a month later with a blog post on a session focused on regulations for medical device clinical trials. But the presenters at the conference shared an enormous amount of insight – a single post could never do it justice. With that in mind, we thought it appropriate to share our takeaways from another session we attended at MAGI 2017 West, this one focused on changes taking place in the industry at large and offering analysis of what’s driving those changes.
Let’s focus on that latter portion first. Clinical research today is an industry in flux, and presenter John P. Neal of PCRS Network largely attributes the current and imminent changes to three principal factors:
- Consumers are paying more for drugs while outcomes have remained static, leading to many treatments being excluded from healthcare plans.
- Drug- and device-development is becoming more expensive and time-consuming.
- On a more positive note, new technology is creating unprecedented efficiencies in data collection.
According to Neal, the effects of these factors are many, and include such changes as increased collaboration among sponsors, increased focus on disease prevention rather than on cures, continued implementation of electronic systems such as consent forms and regulatory documents, and an evolution in some clinical research-related jobs.
What about sites?
Among the many budding trends in clinical research that Neal discussed in the presentation were a number of changes related to clinical trial sites. Because Medrio, as a provider of eSource and ePRO tablet apps, has a direct window into site operations in all kinds of clinical trials, we took a particular interest in this portion of the presentation. How might site operations change in the coming years, and what will be the role of technology in helping them to adapt to those changes?
The expectations on the horizon for sites essentially amount to consolidation: Fewer sites will participate in clinical trials, but those that do will be busier. Neal predicts that more procedures will take place at the offices of primary care providers rather than at clinical trial sites, and that trials will increasingly utilize wearables and other mHealth technology to capture data remotely. All of this adds up to a reduced need for patient visits and on-site data capture. This doesn’t mean, however, that clinical trial sites are going the way of the dodo – not only will they still be in use, but new efficiencies in identifying and screening patients for clinical trials will actually increase enrollment – and, in turn, the workload – at those sites where patient visits are still conducted.
In the clinical trial landscape that Neal envisions, site staff will have a lot to do. If this feels daunting, though, they can take solace in the fact that these changes are occurring in the technological golden age for clinical trial operations. Many trials today have used eSource to catalyze data entry and essentially eliminate paper usage at the site level – crucial capabilities for sites handling large enrollment numbers under tight timelines. Medrio has had a front-row seat for these developments, and we’ve marveled at what sites have been able to achieve with the clinical trial technology available today.
Of course, we also take pride in being part of this technological wave. Neal characterizes the motive of clinical trial technology today as “expanding research while simultaneously bringing the cost down,” and cites a wave of software solutions aimed at making site operations more efficient. As a site-inclusive eClinical innovator aiming to spur clinical research by creating cost- and time-efficiencies, this is a sentiment to which Medrio can certainly relate.