If Technology Doesn’t Empower Research Sites, It Risks Slowing Down Clinical Trials

Ryan Jones is the cofounder and CEO of Florence Healthcare, a leading clinical trial software company.

Clinical research sites have faced unprecedented challenges in 2022. The resignation rate for healthcare workers continued to increase throughout 2021 and early 2022, reducing staff numbers to the lowest levels in recent memory.

At the same time, the number of patients enrolling in studies declined. This decline created additional stress for sites that needed to find diverse patients or patients with highly specific genetic makeups for precision medicine trials.

By automating low-level processes or eliminating duplicate work, technology can provide the boost in output needed to overcome resignation rates and low enrollment. But technology can only help clinical trials if vendors listen to sites’ needs and focus on tools that help the places where the work of research predominantly gets done—trial sites.

Enabling research teams with site-friendly technology can speed up drug development timelines and help new treatments reach the patients waiting for them. This trend ushered in a new category of technology investment in 2022 known as site enablement.

Here’s how the tech industry can build site enablement platforms that address researchers’ needs.

1. Listen to the research sites that will use the platform.

Seeking feedback from customers may seem like an obvious step when building technology. However, tech vendors have historically only asked for input from the sponsors who fund trials—not from the research sites that run them.

As tech vendors, we need to listen to sponsors. But we also need to:

•Talk to staff from local research sites, hospitals and academic medical centers

•Include representatives from sites on customer feedback calls and advisory boards

•Take into account sites’ daily workflows, which are often very different from those of sponsors

Sites manage regulatory documents and data entry while also providing patient care. That means they need streamlined researcher-first workflows that are designed for researchers and that save them from repetitive data entry and manual paperwork—workflows that a site enablement platform should have.

2. Let sites own their technology.

Historically, clinical trial sponsors have chosen a form of tech that worked for them, then handed portals to their sites. Research sites had to manage their documents in a paper binder or a separate platform, then scan and upload them to the sponsor portal. They also had to adapt to new technology for every sponsor they worked with.

Switching between tech platforms can slow down clinical trials, forcing patients to wait longer for new treatments. So how can tech vendors help? Start by letting sites own their technology.

Sites can pick out and buy their own platforms. If sponsors buy the platforms for their sites, they should choose platforms with built-in site workflows and allow sites to control which documents and data the sponsor can view. Either way, it’s time for tech vendors to create platforms with the sites’ needs in mind.

Perhaps it’s simple, but the first way to enable sites to close the capacity gap is for drug companies to fund sites’ own technology selections.

3. Focus on collaboration.

Enablement goes beyond the trial site. Ultimately, clinical research technology needs to make it easier for sponsors and sites to work together. This means giving sponsors and sites the ability to create, edit and sign documents and input data, and exchange those documents and data with each other. It is important that sites can share their data with sponsors before the trial even begins. Sponsors can use that data to determine what sites are the best fit for the trial.

The site and sponsor can then continue collaborating throughout the course of a study. Whether the site is going through study start-up, patient visits and data collection, or study closeout, they’ll be able to immediately show sponsors the documents and data they’re working on. No more waiting on in-person monitor visits or downloading, printing and emailing documents.

4. Embrace integrations.

The average research site uses more than 12 systems to run a single trial. If technology vendors refuse to build integrations between platforms, extra technology will only slow research sites down.

Clinical research technology companies can begin by building software with an open API. Then, robust integrations teams can be built and ensure preparation to build integrations with other industry platforms.

Building a closed platform—a platform that only integrates with software from the same vendor—may seem financially lucrative, but it’s not in the best interest of research sites. There won’t simply be one platform that wins: sites will forever have to enter the same data multiple times in different systems.

Integrations present a practical approach to a research landscape that will continue to feature multiple systems. The vendors that lean into integrations the most may obtain an advantage and help advance cures fastest.

Clinical trial technology should focus on site enablement.

Faced with limited staff and complex protocol and patient requirements, many research sites are struggling to keep up with all of the trials they need to run. And technology that ignores sites’ needs risk making trials less efficient.

Technology vendors have the power to accelerate clinical trials. If we pair awareness of sites’ needs and workflows with site-sponsor collaboration and integrations, we can build platforms that enable research sites instead of holding them back.

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