thanks CD. From page 16: In studies with seriou

thanks CD. From page 16:

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.

So this guideline does anticipate the need for adjudication in the case of a deadly disease, and I think it says that the adjudication is accomplished statistically using pre-specified numbers.