Does Focus Improve Operational Performance? Lessons from the Management of Clinical Trials

For over three decades, the benefits of operational focus have been touted under the guiding principle that dedicated attention to a subset of linked tasks will improve performance. The empirical evidence on the benefits of focus, however, is mixed. We explore the effect of operational focus by studying the investigative sites in biopharmaceutical clinical trials. Within a given trial, multiple investigative sites recruit eligible volunteers, enroll them into a common clinical protocol, and process them according to the same quality specifications. Because these sites vary substantially in their organizational structure, this setting allows us to examine whether focus is associated with increased operational performance, as measured by patient enrollment across a given trial. After controlling for selection, scale, and learning effects, we find that sites that focus on performing clinical trials significantly outperform those that mix trial activity with the provision of traditional patient care. Diversified sites that separate clinical trial activity and traditional patient care through a quot;plant-within-a-plantquot; structure achieve performance that is statistically equivalent to that of a fully focused site dedicated solely to clinical trials. Finally, we find that sites characterized by focus only at the level of front-line production workers experience similar benefits to those characterized by focus only at the level of management