Virtualized clinical trials, also known as hybrid trials, decentralized trials, remote trials, and direct-to-patient trials are a relatively new method of conducting clinical trials where parts or all of the trial happen outside of a traditional trial site. These solutions are designed to lower the burden placed on trial subjects to learn new technologies, limit the number of devices to carry with multiple logins, and facilitate access to remote data capturing tools.

This paper covers frequently asked questions relating to trial virtualization, including:

• What are some key considerations to make when deciding if a trial can be virtualized? Can all trials be carried out with a virtual model?
• What if the sponsor isn’t looking to go fully virtual on a study? Does Medidata have a solution for that?
• How are patients recruited and enrolled to participate through a virtual trial model in comparison to traditional methods? What are some key benefits of using virtual methods?
• What does the patient journey look like from consenting to participating in a clinical trial with virtualization technologies?
• What were some challenges sites faced during the COVID-19 pandemic and how can virtualizing technologies ease some of those burdens?
• What are the regulatory bodies saying about the adoption of these technologies?
• There are many new digital health-care-related technologies becoming available through varying vendors. Doesn’t the use of so many different tools increase the site burden with multiple logins and training?