The role of clinical trial technology in creating and managing frontier sites
Historically, clinical trials have been concentrated at academic medical centers, large hospitals, and cancer centers. But under this approach, trials aren’t as inclusive or accessible as they should be. Bringing clinical trials to frontier sites–pharmacies, labs, doctors’ offices, and health clinics–can make clinical trials more accessible to thousands of patients.
70% of the U.S. population lives more than 2 hours away from the closest academic medical center. This distance renders trials inaccessible to people who work strict hours, don’t own a car, or rely on public transportation–and this has devastating effects on clinical trial diversity.
In 2020, African American/Black patients made up just 8% of clinical trial participants, and Hispanic/Latino patients made up just 11%. Patients over 65 and patients with disabilities were also underrepresented.
By partnering with frontier sites, sponsors and coordinating centers can make their trials more accessible and patient-centric. But to do this, we must learn from the successful multicenter trials of the past and employ remote technology that links frontier sites, sponsors, and coordinating centers.
Why frontier sites are important
Frontier sites offer tremendous benefits to patients. The most common reason rare disease patients gave for not joining trials was the inconvenience of travel. Bringing trials to local pharmacies or doctors’ offices eliminates the burden of driving for hours and lets patients who rely on public transit join trials.
As Gunnar Esiason, a patient advocate and participant in multiple clinical trials, told Drug Store News, “The amount of time that people spend to receive clinical trial care is mind-numbing. Clinical trials should be done at a patient’s convenience. I’m certainly enthused that the major pharmacy chains are taking clinical trials on.”
Frontier or community sites can also lead to greater diversity. 81% of Latinx and 74% of African American patients said they would participate in a clinical trial if their local doctor recommended one to them.
Studies like the SPRINT blood pressure trial have also proven that community sites can make trials more inclusive. The SPRINT trial:
- Employed 19 coordinating centers and 102 community sites
- Recruited 15,000 participants, more than their 9,000-participant goal
- Engaged 7,500 patients of color
Challenges of community sites
But using community sites also presents challenges. Patients will still need to visit academic medical centers for advanced treatments and procedures. Many community sites also don’t have experienced regulatory staff to handle all of the documentation clinical trials require.
Sponsors and coordinating centers need to think creatively about how to engage with frontier sites so we can make trials more accessible without sacrificing compliance or data integrity. Fortunately, multicenter trials of the past provide multiple examples for how experienced sites and sponsors can bring new sites into research.
Different methods for working with frontier sites
Sponsors, CROs and coordinating centers have several options for how to engage with frontier sites. Here are just a few of them:
- Sponsors can work directly with frontier sites to help them grow their capabilities
- Sponsors can employ experienced CROs or site management organizations (SMOs) to work with community sites
- Experienced academic medical centers/coordinating centers can guide frontier sites through running a trial
Sponsors going directly to frontier sites work best for trials where patients don’t need the advanced medical procedures AMCs offer. Sponsors have successfully used this method for lower back pain trials, for example.
CROs and SMOs can also work with frontier sites to help them understand the complex protocol requirements of clinical trials. Because these organizations work with a wide variety of sites, they can educate new Principal Investigators (PIs) and frontier site staff on clinical trial regulations and how to compile documents and data.
Finally, academic medical centers like Stanford, the University of Michigan, Johns Hopkins, and the University of Rochester already have coordinating centers that run multicenter trials. These organizations can help bring investigator-initiated or grant-funded studies to frontier sites.
Experienced PIs at coordinating centers can also serve as mentors to new, diverse PIs. Support and mentorship are critically important, because 49% of PIs participate in just one trial. Support from coordinating centers can help prevent this turnover.
But for sponsors, CROs, SMOs, or coordinating centers to support new PIs and new frontier sites, they need immediate, constant connections to those sites. This is where technology comes in.
Technology and collaboration with community sites
Setting up clinical trials is a complex process, and new-to-research sites need support to ensure they complete their regulatory documents and record their data accurately and compliantly. This is why remote site access software is so important.
When community sites upload their documents and data to a central electronic Investigator Site File (eISF), the sponsor, CRO, SMO, or coordinating center can instantly view those documents and provide comments within the platform.
The sponsor or coordinating center can also deploy study start-up and regulatory packets to each site. These packets can include defined binder and folder structures, document templates, placeholders, and pending tasks so frontier sites can easily see what they need to do to begin their study.
Although remote site access technology can make trials easier for frontier sites, it’s important to remember that many frontier sites don’t have dedicated IT staff. Frontier sites need software that:
- Has high ratings for ease of use, ease of setup, and quality of support from third-party resources like G2
- Offers an implementation team that can walk them through setting up technology
Sponsors, CROs, SMOs, and coordinating centers should also search for remote access software that combines ease-of-use with advanced features.
How software should help sponsors, coordinating centers, and sites
When discussing the potential of bringing frontier sites into clinical trials, Gunnar Esiason remarked that remote access software, “takes away the operational nightmare of getting a trial up and running at a site that’s not a medical center by deploying the technology that is required.”
Esiason’s quote highlights the most important aspect of remote access software: it makes clinical trial operations easier. Setting up binders and folders full of regulatory documents and source data can be overwhelming for pharmacies, small physicians’ offices, or community health clinics.
By giving frontier sites an eISF with binder and folder structures, document templates, placeholders, and tasks, sponsors or coordinating centers make it easier for those sites to get up and running.
But what abilities do frontier sites and sponsors or coordinating centers need from their tech? Here are just a few:
Frontier sites need:
- An eISF that they have control over
- Different roles and permissions for different users
- Document templates, pending tasks, and placeholders to help them upload and complete documents more quickly
- Integration with their Electronic Health Record or Electronic Medical Record (if they have one)
Sponsors, CROs, SMOs, or coordinating centers need:
- Instant, remote access to the eISF (with set permissions)
- The option to build start-up and regulatory packets with set folder structures and document templates
- Bulk distribution of start-up or regulatory packets to multiple frontier sites
- Continual remote monitoring of documents and data
- Integrations that let them transfer documents to their eTMF
- Dashboards so they can evaluate how sites are performing
With these features, sponsors or coordinating centers can help frontier sites set up and successfully run their trials–and frontier sites can focus on patient care and data collection instead of on figuring out which documents they need to complete.
For more on how remote site access software can help frontier sites, check out our free capabilities checklist.
Using Technology to Increase Compliance
Clinical trial regulations are complex, and it’s difficult for frontier site staff to become experts instantly. Technology can help frontier sites stay compliant with all of these complex regulations during their first study.
For example, frontier sites can benefit from:
- Audit trails that automatically track changes to documents, so site staff don’t have to do so manually
- Electronic signatures that are Part 11-compliant out of the box
- The ability to quickly redact Protected Health Information (PHI)
These tools make it easy for community sites to avoid compliance errors. Remote access software also empowers monitors to catch mistakes sooner and guide frontier sites through how to fix them. 75% of CRAs found they could identify issues with site documents earlier using technology than when they used exclusively in-person monitoring.
No technology can instantly teach a frontier site how to participate in a clinical trial. New Principal Investigators and site staff will always need dedicated training and mentorship from sponsors, coordinating centers, CROs and SMOs.
But an eISF with templates, placeholders, tasks, and built-in compliance features can help frontier sites feel better-prepared and more empowered to run trials.
Clinical trial technology and frontier sites
By bringing clinical trials to pharmacies, doctors’ offices, labs, and clinics, we can make groundbreaking treatments more accessible to all of the patients who need them. But we have to ensure those sites can successfully run trials without an abundance of staff or advanced equipment.
Sponsors, CROs, SMOs and coordinating centers can use technology to collaborate with frontier sites on an ongoing basis. An eISF platform with remote access lets frontier sites communicate with larger organizations and use preset structures, templates, and tasks instead of being abandoned to figure out trials on their own. And this support empowers frontier sites to do their most important job–taking care of patients.
To learn more about the power of frontier sites, check out our article on “How Community Sites Can Improve the Lack of Diversity in Clinical Trials.”
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