Lay Summary Development—The Oregon Trail Of Regulatory Writing

By Kelsey Brown, Medical Writing Manager, TransPerfect Life Sciences

The Oregon Trail: one of the most iconic and cherished computer games of all time, filled with boxy graphics, heartache, and the occasional bout of dysentery. Players took on the role of wagon party leader, navigating the unchartered frontier of the Wild West in 1848—all the way to Oregon's Willamette Valley. Gamers found themselves thrown into a world where strategy was essential to choosing how to navigate the trail while preserving resources and supplies.

The world of lay summaries is a bit like the Oregon Trail, where authoring and review processes have yet to be navigated by many study sponsors. Impending regulation throws study teams into the Wild West of regulatory documentation, where they are forced to use available resources to keep up with legislation. What happens when resources are limited or the path is unclear?