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; rather, they are treating them in silos. And that’s a mistake