Virtual Trials and Real-World Evidence Data Collection: Identifying Core Needs and Defining “Virtual Trials”

Mar 26, 2020

Posted by Evidera, Inc.

There is increasing recognition of the need for more fit-for-purpose evidence in development of therapeutics (drug, device, and digital). In the US, in response to the 21st Century Cures Act, the US Food and Drug Administration (FDA) has developed a framework for evaluating real-world evidence (RWE) to support approvals of new indications for previously approved therapeutics and address post-approval study requirements. The collection of RWE is enabled by virtual trials, or decentralized approaches to patient identification and data collection. To inform this approach, we must first understand who the stakeholders are and what their needs are as well as begin speaking the same language around virtual trials; there is no widespread consensus on terminology. Understanding these foundational needs and aligning on definition enables early planning to incorporate such strategies.

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