May, 2024
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Bishal Gyawali: Questions to ask when OS has improved
Apr 19, 2024, 18:30

Bishal Gyawali: Questions to ask when OS has improved

Bishal Gyawali, Associate Professor in Medical Oncology and Public Health Sciences in the Division of Cancer Care and Epidemiology, at Queen’s University, shared a post on X:

“Deep down, even the proponents of invalid and untested surrogate endpoints, know that OS matters. That’s why there is (appropriate) celebration when a drug improves OS but I wonder where that acknowledgment of the importance of OS endpoint disappears when cheerleading marginal drugs based on 20% RR in 30 patients.

Also, when the OS has improved, you should ask the following questions:

1. Did the control arm get standard of care?
2. Did the control arm crossover to the experimental arm if the experimental drug is already SOC at relapse?
3. Did the control arm get appropriate post-protocol therapy?
4. What was the impact on QOL?
5. What is the magnitude of benefit? Not just the P-value but the c-value (clinical significance).”

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