Adopting a Decentralized Trial Strategy: Your Questions Answered

Virtual 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 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 answers the following relating to decentralized trial models:

• Key considerations to make when deciding if a trial can be decentralized
• Options if a sponsor isn’t interested in going fully virtual on a study
• How patients are recruited and enrolled to participate through a virtual trial model in comparison to traditional methods
• What the patient journey looks like from consenting to participating in a clinical trial with virtualization technologies
• Challenges sites faced during the COVID-19 pandemic and how virtualizing technologies can ease some of those burdens
• What regulatory bodies are saying about the adoption of these technologies
• What new digital health-care-related technologies are becoming available

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