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Trial duration on the rise in oncology
January 2015
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CHICAGO—KMR Group recently reported that the duration of oncology trials has increased steadily within the last 10 years. The group investigated cycle time trends for more than 4,100 oncology trials across 32 companies, with study duration defined as the interval from protocol approval to database lock. Within the last decade, oncology cycle times have risen in both Phase 2 and 3 trials; Phase 2 oncology trials now take approximately one year longer than trials held a decade ago, while Phase 3 trials are taking almost five years, one-and-a-half years longer than trials conducted in 2003 to 2005. The increase can be attributed partially to cancer-specific considerations, such as increasing protocol complexity and longer treatment periods; Linda Martin of KMR Group noted that “the enrollment and treatment processes have expanded by almost six months each (treatment duration nearly doubled since 2003-2005).”

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