Statistically significant.

It’s not the same as clinically significant. Recent research is boldly asking how many of the statistically significant results of recent immunotherapy trials are actually, well, significant. Since this is not a novel question for Europeans, long standing ESMO standards were used to novely assess >100 randomized trials founding the bases for US FDA-approved oncology drugs over the last decade. In doing so, international (non-US) researchers reported less than half of these trial results met a clinically meaningful threshold. To top it off, last week Israeli researchers reported that only 3 of 23 recently US FDA-approved indications across six immunotherapies met a clinically significant durable survival benefit as defined by none other than ASCO itself. This all brings up two concerns: Resource. Utilization.


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