Facing protocol amendments head-on

The unplanned costs and delays as­sociated with protocol amendments have prompted many sponsor com­panies to identify new approaches to simplify protocol designs and reduce the frequency of protocol amendments over the course of the past few years. Yet a new Tufts Center for the Study of Drug Devel­opment (CSDD) analysis found that the majority of protocols still require sub­stantial amendments, which led to signifi­cantly longer clinical trial cycle times and higher costs. The new analysis builds on a 2010 Tufts CSDD study that, for the first time, quantified the prevalence and causes of protocol amendments. It found that 57% of protocols had at least one substantial amendment and nearly half (45%) of these amendments could have been avoided, compared to 33% in 2010. About one in four (23%) amendments were implement­ed before the first patient was dosed.

The long wave goodbye to phantom PIs

Efforts to reduce the number of phan­tom investigators—principal inves­tigators (PIs) who are not adequately supervising their staff and clinical trials—appear to be having a measurable impact. But problems associated with phantom PIs and their causes linger. “We are still suffering from huge issues of PI disengagement,” said industry veter­an Beth Harper, president of Clinical Per­formance Partners, a company that helps get sites back on track following large errors in their data or processes. “And I think, in part, we’ve created this problem."

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