Rethinking Quality in Clinical Trials

Author(s): Jim Kremidas

How many times have we heard that there’s a ceiling to the speed of clinical trial delivery? “Move too fast, and we put the fundamentals at risk.”

Now, the concern isn’t about speed per se. Fast, reliable studies are the goal many of us are chasing. The “objections to speed” center on how well trials can be executed at pace: whether sites follow protocol, whether patients are appropriately assessed, and whether data can support confident decisions. Speed is valued, but not at the expense of quality.
Recent analysis suggests that performance doesn’t have to be negatively correlated with speed. If trial performance is supported at an operational level by infrastructure and training, high-quality trials can be delivered safely, consistently, and quickly.