Ryan Jones is the co-founder and CEO of Florence Healthcare, a leading clinical trial software company.
The Covid-19 vaccine studies showed that clinical trials must find more participants, especially diverse participants, and one way that might help is by going multinational. Technology made it possible for research sponsors to communicate and share documents and data with multiple sites around the world, even when travel was restricted.
Holding trials across multiple countries doesn’t just help vaccine trials—it can also help clinical trials that have strict enrollment requirements, like biomarker-driven oncology trials. Additionally, expanding clinical trials benefits patients living in low- or middle-income countries, who often have fewer treatment options.
Going multinational is only possible, however, if sponsors and contract research organizations (CROs) have consistent and always-on remote access to their research sites. This is where technology plays a vital role. Software can help sponsors perform remote monitoring, involve local sites around the world in trials and even follow new regulatory guidance.
How Remote Collaboration And Distributing Expertise Can Help Clinical Trials
Pharmaceutical trial sponsors are responsible for patient safety and the quality of a study. They must monitor and audit the performance of the trial sites that they work with. To do this, they either need to send their own clinical research associates (CRAs) to monitor trials or enlist the support of the CRAs at a CRO.
In the past, monitoring represented a major barrier to expanding trials internationally. CRAs spent roughly 60% to 80% of their working hours traveling to sites via car or plane before the pandemic. When monitors could only monitor sites in person, holding multicountry trials was expensive and time-consuming.
But technology has eliminated many of these barriers. Monitors can now review sites’ data and regulatory documents online with a few clicks. If a CRA notices that a document needs to be updated or added, they can leave a message for the research site and see the updates on the same day.
Remote monitoring also enables sponsors to detect protocol deviations more quickly. Because countries can vary in their drug supply chains and in their ability to transmit samples, images or scans, expanding to new countries could lead to a greater risk of these deviations.
Further, cultural differences in communication styles can create unpredictability and lead to errors—errors that would only surface at the next site visit, which might be six to eight weeks away under a traditional monitoring model.
Remote monitoring lets CRAs detect protocol deviations quickly and prevents other human errors from going unreported. It also allows managers to communicate with sites immediately about how to fix issues, making holding trials in new countries a realistic possibility.
How Underserved Patients Around The World Can Participate In Clinical Trials
Lack of diversity is a major problem for U.S. clinical trials, as the FDA recently highlighted with their new diversity and inclusion guidelines, and around the world. Lack of geographic access to trials causes problems on a micro-level–inside cities or counties—and on a macro-level—inside countries around the globe.
Oncologists from low- and middle-income countries refer to lack of funding as the number one obstacle that prevents them from running clinical trials. High-income countries have approximately 100 times the number of clinical trials per capita that low-income countries do. This creates a worldwide injustice: Patients in high-income countries often have access to the latest treatment options, including treatments still in clinical trials, while patients in low-income countries often do not.
This mirrors our geographic diversity problem at home—high-income U.S. counties have access to superior treatment options that low-income counties do not.
Sponsors have the funding that sites in low-income countries or regions need to run trials. Sponsors, CROs and larger, more experienced sites can also help these smaller sites with studies’ protocol and regulatory requirements. For example, online drives, clinical trial eRegulatory systems and video calls make it possible for sponsors to send sites document templates, protocol guidance and training documents instantly.
This document and data-sharing creates a win-win scenario: Patients in underserved countries receive access to the latest medical treatments, and sponsors diversify their patient pools, leading to more meaningful, accurate clinical trials.
How Pharma Sponsors Can Incorporate Technology Into Their Multinational Trials
If sponsors and CROs want to use technology for their multinational trials, how do they go about it? I suggest the following steps:
1. Find out what technology your sites are already using so that you can decide on a standard for your study.
2. Provide technology if sites do not already have it.
3. Work with your tech vendor to set up training and standard operating procedure (SOP) revisions.
If your sites already have an electronic investigator site file (eISF) in place, for example, they may be able to grant you remote access to view their documents and data. This makes monitoring across countries much easier.
If your sites don’t yet have technology, giving them a secure eISF with remote access will probably be your best option. Why? Sites already have to use an ISF to store their documents. By connecting to their eISF to view documents, you’re working within their existing workflows instead of forcing them to adopt new ones.
Sponsor portals, where sites upload documents once they’re complete, were a popular option for remote access in the past. But they add extra steps for sites that must transfer files from the ISF to the new system.
When providing new technology to sites, you should also look for vendors who offer extensive training—both to you and to sites—and who will help you revise your SOPs. Many clinical operations professionals hesitate to adopt new technology systems, so finding a vendor who understands change management and the needs of clinical research teams is essential.
Technology Can Help Clinical Trials Reach More Patients
Multinational clinical trials can give more participants access to cutting-edge medical treatments and improve health equity around the world. Although technology alone won’t make multi-country trials a reality, it can help by giving research sponsors an instant connection to sites in underserved countries. And with that instant connection, faster and more inclusive clinical trials can become a reality.