Hybrid clinical trials to generate real-world evidence: design considerations from a sponsor's perspective

Randomized controlled trials have traditionally been the gold standard for evaluating efficacy and safety of medical products and for regulatory decision-making. With the advancement of information technologies, vast amounts of data pertinent to patient health status and health care delivery are becoming available from a variety of real-world sources, including electronic health records, medical claims, patient registries, and patient-generated data. In 2016, the United States Congress passed the 21st Century Cures Act, mandating the U.S.

Source: Contemporary Clinical Trials - October 23, 2019 Category: Radiology Authors: Ming Zhu, Saranya Sridhar, Rosalind Hollingsworth, Ayman Chit, Tammy Kimball, Kerry Murmello, Michael Greenberg, Sanjay Gurunathan, Josh Chen Source Type: research