Originally published March 2015. Updated June 2023.
Somethings never seem to change. Sadly, we are still needing to fight for trials that serve the patients, not the other way around. This can be particularly challenging in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL / SLL) trial design.
Dr. Susan O’Brien eloquently addressed the issue of equipoise in clinical trials a full 10 years ago. This ASCO post article from 2013 should be mandatory reading for all patients and all those who design or conduct clinical trials. Please carefully read what she has to say about the important Resonate trial in CLL that led to the approval of ibrutinib, and how these breakthrough medications have changed how we should design future research. There are lives in the balance. She told me: “They will have to allow crossovers.”
CLL Society is advocating on the patients’ behalf with the FDA and anyone who will listen.