As with many technological innovations, the pharmaceutical industry was initially slow to embrace virtual trials. But COVID-19 accelerated interest in the use of these tools as a way to keep trials running through the pandemic.

It was an unexpected shift, but it has helped many sponsors and sites see the value of virtual for clinical research and identify where and when virtual trial elements may bring permanent benefits to clinical research, even after the pandemic is over.

Trials in crisis

When the pandemic hit, trial sites rapidly shut down, CRAs faced travel bans, and study participants became unwilling or unable to attend scheduled appointments. Sponsors and their partners scrambled to find ways to keep patients safe and trials on track.

Regulators were quick to step in, and their advice was clear: virtual trials may offer the best solutions for maintaining trial continuity.

Within weeks, virtually every regulatory body in the world published guidance documents or advice suggesting the adoption of virtual trial elements. These included remote monitoring, televisits, homehealth visits, and delivering investigational drugs directly to patients. Even regulators that have been historically opposed to virtual trials allowed for their limited use when appropriate during the pandemic.

Virtual trial solutions gave sponsors a much-needed lifeline to continue their research. The support from regulators indicated that agencies see virtual components and patient-centric technologies as a viable solution in this crisis, giving site leaders a roadmap to keep patients safe and maintain continuity in their trials.

An integrated response

Being told that virtual trial technology was an acceptable alternative was just the first step in the transition for many sponsors from site-based trials to leveraging virtual elements. Trial sites across the globe had to rapidly figure out what tools they could use, how to use them, what laws affected their application, and how to adapt their workflows and communication strategies to accommodate the changes.

Usually, sponsors would have months to plan a virtual trial, carefully selecting each device, platform, and method of data collection to increase patient centricity while meeting the needs of investigators, patients, regulators, and the trial protocol. During the pandemic, these decisions had to be accelerated for in-flight trials that were not designed with virtual elements in mind.

In response, IQVIA established a COVID-19 task force and risk assessment workflow, powered by dedicated teams whose sole focus was to read regulations related to COVID-19, interpret their potential impact on current and future studies, and advise study teams, sponsors and site staff on how to adapt. These workflows helped IQVIA conduct initial risk assessments with the sponsors to determine the appropriateness of televisits, remote monitoring, and other virtual trial elements on a study-by-study basis. Study teams used the risk assessment tool as a framework to determine the best and fastest way forward.

In parallel, trial sites implemented a combination of virtual trial capabilities based on their unique circumstances. The selection process depended on several factors, including:

1. Whether regulators allowed the use of specific virtual trial technologies.
2. The level of urgency needed to accommodate trial patients in need of treatment and oversight.
3. Patient privacy rules that impacted how and where data could be gathered, viewed, and stored.
4. Site leaders’ willingness to embrace these technologies and encourage their use.
5. The technical abilities of CRAs, investigators, site staff, and the patients using these tools.

Maintaining patient safety was the key element of every decision made in the wake of the pandemic. Sites needed to be sure the solution they adopted met patients’ medical needs within a technology-enabled environment that was safe, easily accessible, and user friendly.

IQVIA’s task force determined the best way to deliver a smooth transition was by taking a “one-stop shop” approach, in which all of the tools the site uses are accessible via a single platform. This allows patients to communicate with study teams and investigators, and CRAs can monitor sites and patients in real time, focusing their attention where it is required.

Choosing integrated tools also reduced the time it took investigators and CRAs to monitor data and made it easier to prioritize activities and reduce risks.

Start with the data

One of the first challenges sites needed to tackle was to assess any safety or integrity risks on studies that did not have remote monitoring as part of their strategy. When CRAs can’t physically visit trial sites to monitor patient safety, trial integrity, and data quality, it can put patients and trial data at risk. It also generates a considerable backlog of data management tasks for CRAs once they return.

By shifting to remote monitoring, CRAs could use a central technology platform to access and review data, and to identify signals and monitor safety trends across sites, subjects and regions. Monitoring key risk indicators consistently and identifying signals quickly was critical to risk management, patient safety, and protocol deviations, which are likely to show an uptick during this period.

In some countries, site staff could share the trial data via a secure online platform that CRAs could access remotely to monitor progress and write reports on iPads. However, in some countries such as Germany, data can’t be shared via cloud platforms when servers are located outside of the country of data origin. In response, IQVIA’s data teams located server farms in these locations to accommodate data privacy rules regarding transfer of personal data.

Another key challenge was ensuring site staff was adequately trained and comfortable using the televisit technologies and data platforms required to keep trials moving forward. Where needed, we provided training on how to use the technology, and tips for engaging patients and capturing insights in virtual patient visits.

To ease uncertainty for patients, we also added a study concierge role to each trial. These customer service experts have in-depth knowledge of the clinical research environment and virtual trial technology. They are available to provide guidance and support to patients in real-time. Add this role took the technical support burden off site staff and gives patients an added expert resource to guide them through the trial.

The future could be virtual

When the pandemic is over, likely sites and sponsors won’t completely forgo the use of virtual trial elements. Most virtual trials already take a hybrid approach, leveraging televisits, remote monitoring, and other tools in combination with traditional on-site study activities to ease patient burden, expand the patient pool, and lower the cost of operations.

These benefits won’t go away in a post-COVID-19 world. And now that sites have some experience using virtual technology to run a trial, and can see when and where it adds value, we think it will just expand their ability to meet the needs of patients and sponsors in future trials.