$SAVA @statnews@adamfeuerstein@MattNachtrab
Adam Feuerstein graduated from Emory University with a bachelor's degree in political science. He got his start in journalism while still in college, interning at an Atlanta business publication.
POLITICAL SCIENCE??? A JOKE!!
In the world of clinical trials, the Institutional Review Board (IRB) is like the watchful guardian of ethical standards. When it comes to open-label extension studies, the IRB's involvement is crucial.
Here's the deal: the IRB's approval is required for any modification to a study protocol, including extending an open-label extension study. The IRB needs to review and approve the extension to ensure that the study continues to meet ethical standards and that the rights and welfare of the participants are protected.
So, to answer your question, yes, the IRB at the FDA (or any other relevant regulatory body) would need to approve an extension to an open-label extension study.
Think of it like a superhero movie: the IRB is the sidekick that keeps the hero (the study) in check, making sure they don't go rogue and start bending the rules.
Hey everyone! I’m considering hosting some spaces on X to cover $sava topics where I bring on an expert or maybe some people from the executive team. X could be good because people that want to protect their identities could come on too. Maybe even bring on some family members or patients on the drug. I’m thinking it could allow me to show you directly what I get to see from my various activities.
If people are willing I could bring on some people that have had challenges with accusations from the fraud hunters.
What do you all think?