COVID-19 put virtual trials in the spotlight of clinical research. When stay-at-home orders, travel bans, and social distancing rules began, sites and sponsors had to rapidly shift course, adopting virtual elements on traditional trials to keep their patients safe, and trial data flowing.

It was a chaotic time for everyone, but some sponsors made the transition smoother, particularly when they choose an integrated virtual trials platform that could be adapted to meet their exact needs. Decentralized trials usually are planned long before recruiting even begins. Sponsors carefully select each virtual technology element, from wearable devices and e-consent forms to centralized monitoring tools, investigator portals, and regulatory information management (RIM) systems. In an ideal environment, these tools will all be accessible via a single platform to create a seamless experience for patients, investigators, contract research associates (CRAs), and sponsors.

During the pandemic, when most transitions to virtual occurred mid-trial, choosing an integrated platform made it possible to shift course with fewer disruptions. IQVIA’s Virtual Trials team found most sites that adopted an integrated decentralized trial platform were running smoothly within two weeks of beginning their transition. However, those that adopted a piecemeal approach, choosing a collection of disconnected virtual tools, spent an average of four-to-six weeks adapting.

Why choose an integrated technology platform

When sponsors make their first foray into decentralized research, they often don’t think about the benefits of an integrated solution that can easily adapt to their to needs. They may choose tools independently based on their own experiences, knowledge, or vendor relationships. And while each selection may offer value in isolation, if the choices they make can’t work seamlessly together, it creates unnecessary risks, time delays, and poor user experience.

One of the biggest complaints we hear about these projects is multiple log-ins. When sponsors choose virtual trial tools that each operate independently, investigators and CRAs are forced to log-in to each tool separately, often numerous times a day. This adds time, creates frustration, and forces these professionals to continually capture and transfer data between systems to conduct meaningful analysis and reports. It also increases the risk that critical data will be lost, creating quality and safety risks.

An integrated virtual trial platform eliminates these security issues. Users have a single log-in that leads them to a portal where they can access every tool and data stream with a single click. That data is also automatically shared across the platform via a shared database, which eliminates the manual cut and paste tasks, and ensures investigators and CRAs have access to the latest data. The best platforms incorporate artificial intelligence tools that can conduct advanced analytics and send alerts when adverse events are detected, or protocol compliance steps are missed. These features accelerate the team’s ability to identify trends, deal with missing, or inaccurate information, and improve patient safety. It also provides reassurance to sites that they can continue to conduct trial oversight within this new operational model.

A more engaging experience

Patients also grow frustrated by virtual trials that lack flexibility, interactivity, and ease-of-use. They expect a seamless user experience that mimics the interface of other technology they use in their personal and professional lives.

Patients expect to access consent forms, surveys, and reports via their device-of-choice. They want their data automatically populated so they only have to enter it once, and to receive alerts and access to their data or site staff when appropriate. They also expect telehealth solutions that are safe and easy to use, and that provide instant support from a “concierge” when technical challenges arise.

Positive patient experiences -- whether in-person or virtual -- will directly impact patients’ willingness to participate in clinical trials. Providing a seamless and flexible virtual environment can go a long way toward improving retention and engagement.

Virtual at scale

Finally, ad hoc virtual trial solutions often face unexpected problems as trials scale. Stand-alone tools may be enough to accomplish early phase research with small localized groups of patients. However, when a trial expands across multiple countries or regions, each of which has its regulatory environment, they often can’t adapt. Some tools don’t have the infrastructure or capacity to handle the deluge of data, while others fail to consider global data privacy laws or rules requiring cloud-based platforms to store patient data locally. If sponsors deploy these tools globally without addressing their shortcomings, they can lose patients, and face stiff fines and lost data due to non-compliance.

Lessons learned during COVID-19

The pandemic is giving our industry a crash course in the benefits – and challenges – of running virtual trials. In the future, we can learn from these lessons to make the best technology choices for patients, site staff, and the data itself.

We believe choosing an integrated platform from a vendor with deep expertise in pharma, strong analytics capabilities, and state-of-the art technology will give sponsors the best chance to make virtual trial elements a valuable and permanent part of clinical research in the future.