Effect of BoM dropouts on trial
posted on
Apr 27, 2018 10:52AM
For G1945V over on Stockhouse in response to an earlier message regarding potential patient drop outs in BoM.
"What happens when patients partaking in the BOM trial should decide to drop out. How does this affect the overall trial in any which way, if at all?"
My opinion is that any 3-point MACE event that occurred while the patient was still in the trial counts. But if the patient drops out, he/she is no longer taking apabetalone/placebo and likely not being followed anymore, so obviously any 3-point MACE event that occurs after leaving the trial won't count. All trials have some patients that opt to leave the trial. That is normal. The obvious effect of a patient leaving is that the accumulation of patient years will decrease and may slow the accumulation of the required endpoint events if enough patients leave. Probably only concerning if a disproportionate number of patients leave from just one sub-group. But like I said, some patients leaving trial is normal and expected. The sample size re-estimation analysis should address this, if a problem exists. Trial is fully enrolled (at least 2400). Come September 2018, ~600 patients will have completed their 2-year dosing, 600 will be at least at 1.5 years dosing, 600 will be at at least 1 year dosing and 600 will be at 1 year or less (unless they died or left the trial, then the number is less ).
BearDownAZ