13 Aug Where does time go in a clinical trial — and why does it matter more than most sponsors think
Clinical trials take a long time. This is treated as a structural feature of the field rather than a management problem. Development timelines measured in years have become a baseline assumption for sponsors, CROs, and site staff alike. What gets less attention is how much of that time is consumed by work that is not the trial itself.
The Tufts Center for the Study of Drug Development has tracked protocol complexity over two decades and found consistent increases in endpoints, procedures, and eligibility criteria per trial. Between 2001 and 2020, the average number of endpoints per protocol increased by 86%, and the number of procedures per protocol more than doubled. Each addition creates downstream administrative and operational work that falls on site staff, CRO monitors, and sponsor teams.
The labor implications are substantial. A 2020 analysis published in Therapeutic Innovation and Regulatory Science found that staff time is the largest single cost driver in clinical trial operations, accounting for a majority of site costs in Phase II and Phase III studies. Most organizations have limited visibility into how that time is actually distributed across trial activities — which makes it difficult to identify where it accumulates unnecessarily, and harder to model staffing requirements accurately for future studies.
[caption id="attachment_75553" align="aligncenter" width="500"] Photo by Polina Tankilevitch[/caption]