|Articles|August 25, 2015

Cycle Time Reduction Remains Elusive

KMR Group reports that the duration of clinical trials continues to hold steady or increase despite ongoing efforts by biopharmaceutical companies to reduce cycle times.

KMR Group reports that the duration of clinical trials continues to hold steady or increase despite ongoing efforts by biopharmaceutical companies to reduce cycle times. KMR Group assessed cycle time trends for more than 6,000 Phase II/III clinical trials using proprietary industry data across 27 companies going back to 2005. The analysis focused on clinical trials across all therapeutic areas. KMR defines total cycle time as the interval from Protocol Approval to Clinical Trial Report (PA-CTR). The analysis reveals that both Phase II and III trials have increased significantly over the last 10 years and continue to rise. Phase III trials took a median 35.7 months for industry in 2005-07 and takes 42.9 months in 2012-14. 

 

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The clinical research industry talks about patient-centeredness constantly but embeds it too late, too narrowly, and without clear ownership, and the cost shows up in enrollment failures, protocol deviations, and outcomes that don't reflect what patients actually care about.