Stock Watch: A Word To Those Considering Unwrapping Clinical Trials Early

When I worked in one of the world’s biggest CROs, its strict data security and trial integrity policies were all part of the on-boarding process even for those of us working in the drug pricing and market access consultancy. These were echoed by the interactions I had with clinical operations, regulatory and statistical teams. However, a number of company announcements have made me wonder whether every drug sponsor is as stringent.

There are legitimate mechanisms for in-progress trial monitoring that do not divert the usual flow of information from investigators to CRO and finally to the drug sponsor while maintaining clinical trial integrity. These are agreed in advance with regulators and included in the statistical analysis plan (SAP) because there will usually be a penalty for an interim look. In 2012, Sunesis Pharmaceuticals, Inc. announced an increase in study size by 225 to 675 patients in its Phase III VALOR study of Qinprezo (vosaroxin) for the treatment of acute myeloid leukemia (AML). This was at the recommendation of its independent drug safety and monitoring board (DSMB) after a single pre-planned interim review of the unblinded data. Sunesis “remained blinded and had no involvement in the interim data analysis, interpretation, or adaptive design