The instrument in play
IRB modernization proposal for the FDA
Exploring modern approaches to physician-led research, real-world evidence, registries, and other methods of generating evidence in personalized medicine.
What is at stake
IRB modernization proposal for the FDA
Patients whose treatment outcomes never reach the evidence base, and physicians who want to contribute what they learn.
Get involved
If your organization has a stake in how this is decided, we would like to hear from you.
Clinical experience is what makes a regulatory argument land. Tell us what you are seeing.
Access questions are not abstract. Your account of them is evidence.
A small number of partners fund this work and sit in the working groups that shape it.