Innovation Pharmaceuticals Inc (IPIX)

[F1ash]

A Data Monitoring Committee is a group of independent experts external to a study assessing the progress, safety data and, if needed critical efficacy endpoints of a clinical study. In order to do so a DMC may review unblinded study information (on a patient level or treatment group level) during the conduct of the study."

"In most cases, safety monitoring will be the major task for a DMC. Even if the safety parameters monitored are not directly related to efficacy, a DMC might need access to unblinded efficacy information to perform a risk/benefit assessment in order to weigh possible safety disadvantages against a possible gain in efficacy. Other reasons for monitoring efficacy might be for futility, checking the assumptions for sample size calculation or whether criteria for early stopping are met. Regardless the kind of monitoring performed, the possible impact on the Type I error has to be taken into consideration when setting up the monitoring guidelines used by the DMC. It is also a responsibility of a DMC to apply appropriate statistical methods (e.g. group sequential methods). Consistency between monitoring guidelines related to efficacy and the statistical methods used for efficacy evaluation as outlined in the study protocol has to be ensured. Thus, if DMC monitoring activities are expected to have relevant impact on the conduct of a clinical trial (e.g. stopping the trial for efficacy, sample size adjustment) the circumstances under which a DMC is expected to consider such recommendations have to be pre-specified not only in the working procedures of the DMC, but also in the study protocol."


So the DMC has the ability to look at unblinded data. They likely also have the ability to recommend stopping the trial for futility if they believed it necessary.

http://osp.od.nih.gov/sites/default/files/resources/WC500003635.pdf