If technology doesn’t allow research sites, it risks slowing down clinical trials

If technology doesn’t allow research sites, it risks slowing down clinical trials

If technology doesn’t allow research sites, it risks slowing down clinical trials

Ryan Jones is the co-founder and CEO of Florence Healthone of the main publishers of clinical trial software.

Clinical research sites faced unprecedented challenges in 2022. The healthcare worker quit rate continued to rise throughout 2021 and into 2022, reducing headcount at the lowest levels of recent memory.

At the same time, the number of patients enrolled in the studies has decreased. This drop created additional stress for sites that needed to find diverse patients or patients with very specific genetic makeups for precision medicine trials.

By automating low-level processes or eliminating duplicate work, technology can provide the increased output needed to overcome quit rates and low enrollment. But technology can only help clinical trials if providers listen to site needs and focus on tools that help where research work is done primarily: trial sites.

Enabling research teams to have site-appropriate technology can speed drug development times and help new treatments reach the patients who expect them. This trend ushered in a new category of technology investment in 2022 known as site activation.

Here’s how the tech industry can create site enablement platforms that meet the needs of searchers.

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

Solicit customer feedback may seem like an obvious step when creating a technology. However, technology providers have historically only asked for the contribution from the sponsors who fund the trials, not the research sites that run them.

As technology providers, we need to listen to sponsors. But we must also:

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

• Include site representatives in customer feedback calls and advisory boards

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

The sites manage regulatory documents and data entry while providing patient care. This means they need streamlined, researcher-centric workflows designed for researchers that free them from repetitive data entry and manual paperwork, workflows that a site enablement platform should have.

2. Let the sites own their technology.

Historically, clinical trial sponsors chose a form of technology 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 them and upload them to the sponsor portal. They also had to adapt to new technologies for each sponsor they worked with.

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

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

It may be simple, but the first way sites can fill the capacity gap is for pharma companies to fund site technology selections.

3. Focus on collaboration.

Activation goes beyond the trial site. Ultimately, clinical research technology must facilitate collaboration between sponsors and sites. This means giving sponsors and venues the ability to create, edit, and sign documents and enter data, and to 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 this data to determine which sites are best suited for the trial.

The site and the sponsor can then continue to collaborate throughout a study. Whether the site is going through study start-up, patient visits and data collection, or study closure, they will be able to immediately show sponsors the documents and data they are working on. No more waiting for in-person review visits or downloading, printing, and emailing documents.

4. Embrace integrations.

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

Clinical research technology companies can start by building software with an open API. Then, robust integration teams can be assembled and ensure readiness for building integrations with other industry platforms.

Building a closed platform — a platform that only integrates with software from the same vendor — might seem financially lucrative, but it’s not in the best interests of search sites. It won’t be just one platform that wins: sites will still need to enter the same data multiple times into different systems.

The integrations present a hands-on approach to a search landscape that will continue to include multiple systems. Vendors that lean the most on integrations can get an edge and help advance treatments faster.

Clinical trial technology should focus on site activation.

Faced with limited staff and complex protocols and patient demands, many research sites struggle to keep up with all the trials they need to conduct. And technology that ignores site needs risks making testing less effective.

Technology providers have the power to accelerate clinical trials. If we pair knowledge of site needs and workflows with site sponsor collaboration and integrations, we can create platforms that enable search sites instead of holding them back.


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