One key issue facing pharmaceutical clinical development organizations has been increasing clinical trial cycle times. Despite substantial effort and attention from the industry on this issue, overall development timelines continue to increase, at both the programme and study levels. Indeed, cycle time continues to be a major area for improvement for drug development, given the current time to market — reported as 13.8 years to go from target identification to first approval in a major market (Pharmaceutical Benchmarking Forum 2016 R&D Performance: Success Rates & Cycle Time, KMR Group, June 2016). Companies that can master the operational challenges and restraints in study design can not only reap rewards of shorter cycle times but can also see first-mover advantages, revenue benefits, longer market protection and improved productivity through reduced expenditure on conducting clinical trials.

In this article, selected results from the Clinical Trial Cycle Time Study, an annual benchmarking initiative conducted by KMR Group, are presented. The study is based on proprietary data, which are collected directly from companies and carefully scrutinized. More than 17,000 interventional studies from 25 sponsors and contract research organizations (including 15 of the top 20 pharmaceutical companies by revenue) that were conducted in 2005–2015 were included in the assessment.

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