Applied Clinical Trials
Virtual trials tools are usually selected early in the protocol development stage, however, due to the COVID-19 crisis, regulators are encouraging sponsors to consider integrating virtual elements into clinical trials already in progress.
While the pandemic may be shutting down restaurants, bars and other businesses, many clinical research efforts are moving ahead, thanks in large part to virtual trials.
With shelter in place and travel bans preventing patients and staff from visiting clinical trial sites, sponsors of all sizes across the globe are switching to telemedicine, remote monitoring, and other virtual trial elements as a way to keep patients safe and studies progressing throughout the pandemic.
These decentralized trial models give sponsors a much-needed lifeline to continue their research, with regulators encouraging their use as an urgent measure to maintain patient safety.
Virtual trials models have slowly gained traction in recent years as sponsors realize that these more patient-centric models help quicken recruitment, improve engagement, and deliver verified data more quickly to shorten overall study timelines. These trials integrate wearable devices, telemedicine platforms, e-diaries, e-consent tools, remote monitoring, and other digital elements to treat and monitor study participants remotely. In some cases these trials are entirely virtual, while others take a hybrid approach to minimize the need for in-clinic patient visits.
Typically, virtual trials tools are selected early in the protocol development stage of the clinical research process and incorporated into the trial plan long before recruiting begins. However, due to the COVID-19 crisis, regulators are encouraging sponsors to consider integrating virtual elements into clinical trials already in progress to address urgent patient safety issues. These remote elements also minimize disruption for study participants, sites, and data collection.
On March, 27, 2020, The US Food and Drug Administration (FDA) updated its Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.1 The document specifically notes that FDA regulations allow for changes to be made to any investigational plan or protocol without prior approval if the change is intended to, “eliminate an apparent immediate hazard or to protect the life and well-being of subjects.” The guidance specifically suggests using virtual assessments and monitoring where appropriate.
That same day, the European Medicines Agency (EMA) produced its Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic2, which also lists virtual patient visits and remote monitoring as potential strategies to maintain trial continuity. We’ve seen similar documents from regulatory bodies across the globe as industry leaders seek innovative ways to protect patients and data.
The rapid and specific regulatory support for virtual tools and models is a sign that regulators see decentralized and patient-centric technologies and approaches as a viable solution to this global crisis, and beyond. However, even with their support, many sponsors and sites are still uncertain how to make this transition-especially in a trial already underway-while still ensuring compliance, continuity and patient safety.
There is no one-size-fits-all virtual solution. Every trial setting and patient population has unique needs. But with the right guidance and support, sponsors can customize their operational format to address these needs, ensuring their trials can continue with minimal interruption.
Sponsors seeking to integrate remote monitoring capabilities, telemedicine, or home health nursing support to ensure their trials continue through the COVID-19 quarantines should work with their clinical research partners to evaluate their original study plans and identify which elements can be adopted without compromising data integrity. With sites closing physical locations across the globe, and regulators demonstrating a willingness to accept broader adoption of virtual tools, there are a number of changes they can make to quickly adapt.
Remote Monitoring: For sponsor’s, patient safety is of primary concern during this pandemic. Many sponsors are considering how patient safety can continue to be monitored when site closures and travel bans prohibit CRAs from being on-site. One option is to adopt a remote monitoring model and appropriate technology to maintain data oversight.
When taking this approach, sponsors must ensure their approach complies with data privacy regulations in the countries where their trials are operating. In locations where it is appropriate, they can consider a remote monitoring solution that offers a central repository for data and automated workflows so CRAs can identify signals, and monitor safety trends across sites, participants, or regions within a fully auditable and traceable environment. Such surveillance and early signal detection is critical during this transition to maintain patient safety and to validate any protocol deviations.
They also need to be certain they have enough capacity to support the increase in data sharing and storage at each site.
Remote patient visits: Once the monitoring system is in place, sponsors can rethink how they will engage with patients. Telemedicine platforms can offer a fast and easy solution, allowing investigators to conduct virtual patient assessments. This can keep the cadence of visits on track and prevent loss of vital data.
However, telemedicine is not as simple as hopping on Skype or FaceTime with patients. These platforms must be compliant with all local patient privacy regulations and verified as an acceptable tool for these highly sensitive patient interactions.
To make this transition, sponsors and CROs should work with sites and investigators to assess their current technology as well as their staff capabilities. Depending on location, a site’s existing high-speed internet is often enough to support a telemedicine platform.
They should also consider what peripheral tools they want to add. They may include electronic diaries and questionnaires to collect patient reported outcomes, wearable devices to capture data remotely from patients, and electronic consent forms, which will need to be updated to accommodate any protocol changes.
Training staff: When adopting virtual elements, you have to be sure staff are comfortable using the tools in a clinical setting. They will need to be trained on how to use the technology and data platforms, as well as how to adapt their patient engagement strategies for a virtual environment. That includes learning to maintain eye contact during telemedicine visits, taking advantage of the opportunity to observe a patient in their own home, and recognizing peripheral signs that a patient might need additional support.
Home visits: Once a sponsor determines which technologies sites will need to replace tasks normally completed during patient visits, they can identify the remaining gaps. This can include lab tests, delivery of study drug, in home care needs, and infusions or other treatments that require a healthcare professional.
These gaps will require some face-to-face contact, but don’t have to happen at the trial site. Partnering with home healthcare nurses and phlebotomists can address many of these challenges by administering drugs, testing equipment, and care directly to the patients’ homes. In cases where a patient must go to a lab or hospital, sponsors can coordinate with concierge services that specialize in safely transporting vulnerable patients.
In an ideal scenario, sponsors have months to make decisions about when and where to use virtual trials, and how to incorporate them into their research strategy. COVID-19 has taken that planning time away, forcing sites and sponsors to rapidly shift gears to keep their trials on track. It’s not an easy transition to make, but with the right tools, expertise, and strategies, CROs can help proactively weather this crisis.
At IQVIA, we are working with our customers, who are running trials in more than 40 countries, to help them keep their vital research moving forward. And we will continue to support them throughout their research to ensure the data they collect during this difficult time is compliant with federal regulations, so they can confidently pursue approvals.
We believe that virtual trials will transform the clinical industry by allowing sponsors to engage with more diverse patient populations, accelerate recruiting, and lower the burden of trial participation. COVID-19 is proving that these adaptable, decentralized approaches can also be a powerful solution in a healthcare crisis.
While COVID-19 is having a global impact, it isn’t the first pandemic we’ve seen-or the last. Time will tell how this current crisis will be a catalyst for change, but the move toward a more accessible approach to research and innovation will undoubtedly be a part of it. Virtual Trials not only bring clinical research into the 21stcentury, they equip our industry with the tools needed to quickly and safely respond to disruption to clinical trial continuity, giving us greater resiliency to face these events in the future.
Christopher Varner is a Project Manager at IQVIA Virtual Trial Solutions