Questioning Medicine4 Nov 2024

Episode 342: 341. Methods Monday! What is the problem with stopping a trial EARLY?

Stopping Trials Early for Benefit: Insights From Recent Pivotal Trials in Chronic Kidney Disease - ScienceDirect

There are 4 major reasons why trials might be stopped early: 1) unequivocal benefit; 2) unacceptable harm; 3) futility; and 4) administrative reasons (enrollment or funding concerns).

trials stopped early for benefit tend to overestimate benefit, a phenomenon referred to as random-high.

trials that stopped early, especially those with <500 events, fail to provide reliable and valid estimates of treatment effect, often overestimating it by nearly 30%

Trials stopped early for harm or futility are less problematic as such data are not used to promote medications.

Published results were based on accrual of 69%, 75%, 93%, and 87% of planned events in CREDENCE, DAPA-CKD, EMPA-KIDNEY, and FLOW, respectively.

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