FDA's DCT draft guidance: A hit or miss?
The FDA's draft guidance on decentralized clinical trials (DCTs) has been released, aiming to reduce regulatory uncertainties and support decentralization in trials. Despite its embrace, challenges remain, including PI oversight, HCP use, data collection scalability, and terminology clarity. The industry seeks more clarity, with the FDA expected to finalize the guidance after considering feedback.
Reference News
The FDA's draft guidance on decentralized clinical trials (DCTs) has been released, aiming to reduce regulatory uncertainties and support decentralization in trials. Despite its embrace, challenges remain, including PI oversight, HCP use, data collection scalability, and terminology clarity. The industry seeks more clarity, with the FDA expected to finalize the guidance after considering feedback.