Broadening the Scope of Clinical Trials: The Changing Role of Real-World Evidence

The role that real-world evidence, and the data that feeds into it, play in the clinical trials arena is changing. For many years, drug developers and regulators have collected real-world data (RWD) on adverse events linked to newly approved medicines. However, this data has not played a significant role in developing or executing pre-approval clinical trials.

The situation is now changing. “There’s always been a need to look at how drugs that are coming out of clinical trials behave in the real world,” Gracy Crane, International Regulatory Policy Lead for RWD at Roche in the U.K., told Inside Precision Medicine.

“A lot of the safety monitoring has actually been done using RWD. But recently, there’s been...