FDA's Decentralized Clinical Trials Draft Guidance
This is a summary of a blog post in Crowell Health Solution's Trends in Transformation. The full text is available here.
FDA published its draft guidance outlining considerations for decentralized clinical trials. These trials, if done well, have the potential to engage patients from a more diverse background, and lower the burden of participating in trials. While a nascent field, there are many stakeholders with great interest in developing the right tools, data plans and protocols to make DCTs a success.