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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