By Amy Ripston
Managing protocol versions at the site level and the broader protocol amendment at the sponsor level go hand-in-hand. Neither is simple, but both sides of the equation must be taken into consideration when designing the study.
Let’s take a Master Protocol Trial as an example. The design of the study allows for changes to either the disease sub-types included or to the treatments explored. By keeping the options open, sponsors can follow any positive signals and refine the treatment as data is collected over the course of the study.
The challenge? These changes are usually rolled out via protocol amendments. So not only does the sponsor need to handle challenges resulting from the amendments including supply chains, quality, and timelines, but they also need to have a process for individually applying those amendments to sites that are currently enrolling patients.