Hawthorne Effect more likely in Statin trials ...or your favorite ..the Reduce It trial :--) These patients are in the ICU , most with sepsis and all with at least one critical organ crashing . They may not even aware they are in the trial ...that decision being made by next of kin and their MD.
So the last data from the Pediatric SAVE registry
. These new data are on track to validate or potentially exceed a 50% reduction in loss of life compared to historical data, as reported in Kidney Medicine.
If the interim review is seeing a 50% ( even 40% ) relative risk reduction in mortality for those on ICU's SCD filter ..vs standard of care ...theres a strong case for limiting further enrollment say past 160 patients . A 40% relative risk and an absolute risk reduction of 20% is probably not enough to cross a strict stopping boundary of p<.01...but definitely a good case to reduce further enrollment . ( ie limit to 160 patients ) That would be a huge break for the Co ...and they definitely need one.
ICU is by far the riskiest and 1 of the smaller positions in my portfolio ... JMO