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Companies seeking to improve global clinical trial timelines have found opportunities through careful assessment of the span from protocol approval to start of randomization in each region. One analysis performed as part of KMR Group's Enrollment Productivity Study assesses how long it takes each company to start in each region.
Although it may vary for certain therapy areas, North America has the shortest start-up cycle time at 4.1 months. Japan is also shorter than average at 5.4 months.
Study start-up cycle time by region.
A major challenge—and a major opportunity—presents itself after the typical first patient is enrolled in the initial region. Some companies have made synchronized start up across regions a priority, yielding improvements in performance for the overall global trials.
Emerging market regions (e.g., Latin America, Eastern Europe, and Asia) require more than twice the time to begin enrollment, compared to the shortest first-region cycle times. This can be due in part to the practice at some companies in the industry to begin enrollment in regions in serial fashion, one after the other. One of the complicating factors in the emerging market regions is that regulatory requirements in certain countries are more difficult to meet.
—KMR Group, https://kmrgroup.com