Thursday, February 25, 2016 12:54:04 PM
<<Many randomized clinical trials are double blind – no one involved with the trial knows what treatment is to be given to each trial participant. Blinding includes the participant, their doctor, and even the study personnel at the company or organization sponsoring the trial. Blinding is breached and true assignments disclosed only after the trial database is finalized.
Clinical trials may go for years, and there is justifiable concern about enrolling participants and exposing them to an unproven treatment without ongoing oversight of the preliminary results. The DMC is a group (typically 3 to 7 members) who are independent of the entity conducting the trial. At least one DMC member will be a statistician. Clinicians knowledgeable about the disease indication should be represented, as well as clinicians knowledgeable in the fields of any major suspected safety effects. Ethicists or representatives from a patient advocacy group may be included, particularly for research involving vulnerable populations. The DMC will convene at predetermined intervals (three to six months typically) to review unblinded results.[citation needed] The DMC has the power to recommend termination of the study based on the evaluation of these results. There are typically three reasons a DMC might recommend termination of the study: safety concerns, outstanding benefit, and futility.>>
So, given that Sunrise Hospitals were requested to send their Sunrise reports by begining of 2016 (say they were sent / received by end of January)... Also, it is logical to assume that their "predetermined" meeting would take place once the DMC members had had the time to read and analyze the data (2 / 3 weeks at least?) and not before that. Or in other words, regardless how many events might have already taken place, there are reasons to believe that that meeting would not have happened yet or is about to take place.
It is also reasonable to think that the amount of data that those reports should provide will be enough as to determine "green light" or not... also regardless the 155 events needed for the 1st look-in happened or not... which I believe they happened (unless Bavi Arm goes to astronomical MOS)
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