Don't Let Summer Obstacles Catch You Off Guard

By Jennifer Dennis-Wall, Ph.D.

In research, anytime variation is introduced and unaccounted for, it can mask the true results of an intervention. Variation can come from seasons, meaning that clinical trials should be accounting for this. The summer season can contribute to variation and can introduce other specific challenges to a clinical trial. Some of these challenges may also appear during the winter months, and fortunately, the same solutions apply.

We humans are different creatures in the summertime. We eat differently, we exercise more (or less) than during other parts of the year, and we spend more time outdoors. Changes in our biochemistry can result. In a clinical study, all of these differences can turn into confounding factors, or factors that are actually responsible for differences in study results that falsely appear to be due to the treatment or intervention.

There are also logistical challenges to running a trial during the summer months. The many holidays and ensuing vacations during the summer months can slow and delay communication between sponsors, investigators, and participants. This in turn can result in missed milestones. Multinational studies may also experience additional holidays from other countries.

There are ways to combat these added challenges when running a clinical trial. Most of these solutions must be implemented during the planning stages of a study, but there are often creative solutions for rescuing a trial failing for seasonal reasons.