[BostonCard]

Man, the communication on that is lousy.  Based on the NY Times article, the company says that the trial was being halted "out of an abundance of caution" for a "potential safety concern", but if you look at the text, it really sounds like the study may have met the criteria for futility because patients who were getting the monoclonal antibody appeared to be doing worse than patients getting placebo, a difference that was large enough at this point in the clinical trial that continuing to enroll patients was "futile" because it was very unlikely that, conditional on the data observed by the DSMB to date, it would be highly unlikely that efficacy could be shown even if the trial was fully recruited.  Obviously, if your drug is making patients worse, that is both a safety and efficacy issue, but unlike the problems that were being seen with vaccines, where a single patient had an unsual adverse event which might have been due to the vaccine, this looks to be based on an overall imbalance between the treated and placebo groups.

That being said, there was a recent case of a clinical trial in Alzheimer's disease that was halted early due to "futility", but then later the company sponsoring the trial (Biogen) claimed that after more data came in, that the drug actually worked and that they planned to file with the FDA.  These claims are hard to evaluate because I don't think the data has been publicly released, but it could be a precedent here.

BC

[BostonCard]

Man, the communication on that is lousy.  Based on the NY Times article, the company says that the trial was being halted "out of an abundance of caution" for a "potential safety concern", but if you look at the text, it really sounds like the study may have met the criteria for futility because patients who were getting the monoclonal antibody appeared to be doing worse than patients getting placebo, a difference that was large enough at this point in the clinical trial that continuing to enroll patients was "futile" because it was very unlikely that, conditional on the data observed by the DSMB to date, it would be highly unlikely that efficacy could be shown even if the trial was fully recruited.  Obviously, if your drug is making patients worse, that is both a safety and efficacy issue, but unlike the problems that were being seen with vaccines, where a single patient had an unsual adverse event which might have been due to the vaccine, this looks to be based on an overall imbalance between the treated and placebo groups.

That being said, there was a recent case of a clinical trial in Alzheimer's disease that was halted early due to "futility", but then later the company sponsoring the trial (Biogen) claimed that after more data came in, that the drug actually worked and that they planned to file with the FDA.  These claims are hard to evaluate because I don't think the data has been publicly released, but it could be a precedent here.

BC