MedCity News January 25, 2023
The agency’s goal is to spur a macro shift in clinical trials. The FDA is trying to tell these companies what it wants to be different in trials across the board with regards to digital health endpoints, the use of real-world data (RWD) as regulatory-grade data, and diversity in clinical trial inclusion.
As we begin the new year, there is a lot of talk in the drug development world about Federal Drug Administration (FDA) guidance documents for clinical and decentralized clinical trials (DCTs). This chatter is understandable because we’re likely to see some emphasis put into previous documents that have not been rigidly enforced.
Unfortunately, a lot of trial sponsors aren’t thinking about these guidance documents in a holistic manner;...