By Catherine Gregor, Chief Clinical Trial Officer, Florence Healthcare

Clinical trial vendors often get overly excited about the potential of technology to reduce site workloads. After spending nearly 20 years at community clinical trial sites and academic medical centers, I know that technology doesn’t always lead to less work for sites–especially when technology means dozens of separate systems.  

But it’s also true that sites need to spend less time on paperwork and data entry. With the rapid growth of clinical trials in 2021 and 2022, many major sites have a backlog of anywhere from 30-70 studies that they simply don’t have time to start. 

At SCRS Oncology Summit 2022, I took part in a discussion about how sites can close their capacity gap to successfully complete clinical trials. We came to the conclusion that technology can reduce the burden on overworked sites–but only if that technology is well-integrated and connects sites to Sponsors.

Sites need help with their workloads 

A record 1,015 new trials started in Q4 2021. At the same time, many sites faced employee shortages and turnover rates of 50%.  

With staff leaving in such large numbers, sites can’t hire fast enough to keep up with trial workloads. In an industry where turnover was already problematic pre-pandemic, the increased instability of today’s job market is placing added pressure on study timelines across the board. 

We already know that out of all the treatments that fail in Phase III clinical trials, roughly 22% of them fail solely because the trials last so long that Sponsors run out of funding. One can only imagine what these statistics will look like in five years if sites and Sponsors cannot figure out ways to make running trials easier.  

At first glance, it seems like technology would be an obvious answer to some of the industry’s problems. If sites and Sponsors can leverage technology to help offset manual workloads and decrease administrative burdens on both sides, we can potentially focus on getting new treatments to market faster. 

But too often, technology actually ends up adding work rather than streamlining it. The rush to solve problems with new software and devices has left many sites stuck managing too many systems that aren’t well-integrated.  

Why the wrong technology doesn’t reduce work for sites 

When sites are forced to use disparate systems, technology can slow down processes instead of accelerating them. 42% of sites log into 6 or more platforms for an average study. These platforms can range from CTMS systems to electronic Investigator Site Files, eConsent systems, EDC platforms, and Sponsor portals. 

The lack of integration between these platforms means that site staff have to waste time on duplicative data entry. As a result:  

• 61% of sites say they wish they could manage all of their operations in a central platform 
• 40% of sites say they hesitate to adopt new technology because of a lack of integrations 

Some technology vendors try to solve this problem by creating a “closed system.” This means that the platforms integrate–but only if you buy all of them from the same vendor. 

Sites often struggle with closed systems because of their lack of flexibility. If you already have software, you won’t be able to integrate it with a new closed-system platform. Because of this challenge, I believe technologies that have an open API and can integrate with one another will serve sites better.  

The importance of an open API and integrations 

Software with an open API has the potential to integrate with software from other vendors. For example, a site could integrate its eISF or eTMF from one vendor with a CTMS, EDC, or EMR from another.

Open-API software lets sites choose the best-in-class platform for each of their needs, then integrate those platforms to eliminate repetitive data entry. But how can sites find open-API software that integrates well?  

The first step is to ask tech vendors whether their software has an open API and what integration services they offer. If a software platform doesn’t integrate with any of your pre-existing software or software you may want in the future, it’s probably not a good fit. It’s also important to look for technology that lets you collaborate remotely with Sponsors and other sites. 

How well-integrated technology can help sites collaborate with Sponsors

91% of Sponsors already use remote monitoring or expect to do so by the end of 2022. That means that sites with remote access technology will have an easier time meeting Sponsors’ expectations and keeping up with the rapid pace of trials. 

However, remote monitoring doesn’t automatically mean less work for sites. If sites have to do all of their work in a different software system and then upload documents into Sponsor portals, they end up spending more time on a monitoring visit than they would if the monitor just came on site. 

This means the workload is no longer worth the reward for sites, and they will be less likely to adopt Sponsor technology and more prone to charge additional administrative fees to cover the time wasted on duplicate entry.

This is why it’s important that sites and Sponsors choose technology that is reflective of site workflows and that allows data sharing through open API. Sites deserve technology that helps them manage data and documents throughout the study lifecycle while still allowing them to facilitate remote monitoring and data sharing with sponsors.  

As an example, an eISF with remote access empowers Sponsors or CROs to continually check on site documents throughout the trial, instead of waiting for check-ins every few months. This leads to more accurate clinical trial documentation. 

When using an eISF for remote monitoring: 

• 75% of Clinical Research Associates could identify issues with site documents sooner 
• 68% of CRAs could help sites fix those issues more quickly 

Meanwhile, sites benefit from a platform that already matches their workflows and that integrates with their pre-existing clinical trial platforms.  

Bringing in new, frontier sites to keep trials running 

But if we want research sites to keep up with the changing pace of clinical trials, we can’t just make sites more efficient–we also need to engage more sites in trials. 

There are a limited number of academic medical centers (AMCs) in the U.S., and they serve a limited patient population, as only 30% of patients live within 2 hours of an AMC. If smaller community sites, like pharmacies and local physicians’ offices, get involved in clinical trials, it will greatly expand the pool of patients who have access to studies.  

Pfizer and Moderna successfully used community sites to find a large and diverse pool of patients for their COVID-19 vaccine trials. The Pfizer trials alone enrolled more than 46,000 participants, 42% of whom were Asian, Black, Hispanic/Latinx, or Indigenous/Native American. Although these trials weren’t as diverse as the world’s population, they were considerably more diverse than average vaccine clinical trials, which are roughly 78% white.  

Adding community or frontier sites also makes trials more patient-centric: 

• Patient advocacy groups rank transportation to trial visits and out-of-pocket travel expenses as major barriers for clinical trial participation 

• 60% of rare disease patients liked that decentralized trials helped them spend less time traveling 

But new clinical research sites aren’t always prepared for the burden of running clinical trials. This is where experienced research sites and technology can step in to help.  

How experienced research sites can use technology to help new sites 

New, community-based clinical trial sites can make trials more inclusive and patient-centric. But these frontier sites aren’t always prepared for the amount of regulatory documentation involved in clinical trials.  

This is where technology can help. Remote access software lets experienced sites partner with less experienced sites to centrally manage some of the more administrative workflows, like regulatory and data entry. 

In turn, community-based sites can help AMCs and major hospitals by taking care of patients closer to home.  

Integrated technology can help sites run efficient, inclusive trials 

With the number of new clinical trials growing each year, it’s impossible for existing research sites to keep up with demand without embracing technology. But technology will only help sites work more efficiently if it integrates with their existing platforms, matches their workflows, and connects them with Sponsors and each other. 

Fortunately, sites are becoming more empowered to tell software vendors and Sponsors what they need. Sites can now request eISFs that offer site-friendly workflows and let them collaborate remotely with Sponsors and community sites: and with that technology, they can overcome their capacity shortage and keep trials moving forward. 

This topic was also discussed on the SCRS Talks podcast. Listen now below:

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About the Author 

Catherine Gregor is a transformational leader and business advisor with close to two decades of experience in clinical research. Now Florence Healthcare’s Chief Clinical Trial Officer, she has worked in multiple therapeutic areas in both academic and community hospitals and most recently served as the Director of Clinical Research Administration for the Vanderbilt-Ingram Cancer Center.

Catherine has an MBA in Healthcare Administration from Belmont University and a Masters in Modern European History from Loyola University Chicago. She is a Certified Clinical Research Professional (CCRP) and a Certified Clinical Research Coordinator (CCRC) as well as a subject matter expert and key opinion leader on patient-centric, decentralized and hybrid trial design. She is passionate about changing the clinical trials industry and empowering women as leaders.