Innovation Pharmaceuticals Inc (IPIX)

[baytdr]

"In the setting of the Phase 2b or Phase 3 trials that are described in the Introduction, in order to reduce the risk of misleading conclusions, access to interim results on efficacy and safety of study interventions should be limited to the statistical group preparing the interim reports and to members of an independent DMC who are guided in data interpretation by proper group sequential monitoring guidelines. As asserted by Ellenberg et al. [1],

‘This principle is justified by the need to minimize the risk of widespread prejudgment of unreliable results based on limited data … this prejudgment could adversely impact rates of patient accrual, continued adherence to trial regimens, and ability to obtain unbiased and complete assessment of trial outcome measures. This prejudgment could also result in publications of early results that might be very inconsistent with final study data on the benefit-to-risk profile of the study interventions.’"