The fact that we are allowed to continue is clear indication we are safe And perhaps efficacious than placebo even if not statistically significant yet with the population considered. Connsidering that placebo is probably remdesvir would this not be enough for FDA to make LL the standard of care where remdesvir does not work by day 14 or what happened to the secondry end point?? What if LL improved symptoms at day 14 more than standard of care?? Sounds like FDA could ask LL to be used on certain patients for sure IF they consider that this is a pandemic. I am assuming LL improved symptoms by day 14. We would not know until end of trial.
4.4.1.1. Monitoring for Effectiveness
In studies with serious outcomes, all parties would wish that any major treatment advance be identified and made available as soon as possible. It is critical, however, that the study yield a valid and definitive result. Thus, tensions between ethical and scientific considerations may arise. Consider, for example, a placebo-controlled trial of a new product for a serious illness or condition for which there is no standard treatment. If the emerging data suggest that those receiving the treatment are doing better, one might expect that a DMC would consider whether the study should be terminated earlier than planned. Estimates of treatment effect, however, will be unstable at early points in a study, and the chance is substantial of observing a nominally statistically significant benefit (e.g., p<0.05) at one of multiple interim analyses during a study of an ineffective product (see Section 4.4.2). A DMC, guided by a pre-specified statistical monitoring plan acceptable to both the DMC and the study leadership, will generally be charged with recommending early termination on the basis of a positive result only when the data are truly compelling and the risk of a false positive conclusion is acceptably low.
A second type of consideration is whether the hypothesized benefit is likely ultimately to be achieved. If the interim data suggest that the new product is of no benefit—that is, there is no trend indicating superiority of the new product—or that accrual rates are too low or noncompliance too great to provide adequate power for identifying the specified benefit, a DMC may consider whether continuation of the study is futile and may recommend early termination on this basis. In this case, false negative conclusions are of concern; statistical procedures are available to guid
