There is ZERO clinical evidence of that ridiculous statement.
Orange juice has no side effects either! While PFS and OS are both important, changed endpoints, crossover and post hoc external controls render a trial null and void. Period, EOM.
That is exactly what NWBO did, and why the FDA sent them packing!
Randomized double blind trials with PFS as the main endpoint with OS follow up as 2nd endpoint are the GOLD STANDARD.
Why PFS is the Gold StandardDirect Measure of Treatment Effect: PFS evaluates how well a treatment delays disease progression, reflecting the drug’s ability to control tumor growth.
Faster Results: Compared to Overall Survival (OS), PFS provides earlier evidence of efficacy, as progression often occurs before death, allowing trials to conclude more quickly.
Less Confounding: PFS is less influenced by subsequent therapies or crossover treatments compared to OS, which can be affected by post-progression treatments.
Regulatory Acceptance: Regulatory bodies like the FDA and EMA often accept PFS as a primary endpoint for drug approval, especially in diseases where progression is a reliable indicator of clinical benefit (e.g., advanced cancers).
Gary
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