Benchmarking Phase 4 clinical trial costs is difficult because the data is almost always “positively skewed.” This means a few extremely expensive trials pull the average up.
We have been able to collect clinical trial cost data from a number of sources, such as US funding databases.
The median cost of trials in our dataset was $1,766,000 and the mean cost was $2,391,000. The standard deviation was $2,787,000. The fact that the standard deviation is greater than the mean, shows just how tricky it is to model trial costs.
Above: histogram of Phase 4 clinical trial costs.
In Phase 4 (Post-Market Surveillance), the scope of a trial can range from a small observational study to a massive, multi-year safety registry involving tens of thousands of patients. A single “mega-trial” for a blockbuster drug (e.g., a cardiovascular safety study) can cost $50M+, which heavily inflates the mean.
Because the mean is so sensitive to these outliers, it often overstates the “expected” cost for a standard trial. The median is a better representation of a “typical” study, but even that misses the massive financial risk of the high-end trials.
A better way to visualise the distribution of the trial costs is to use a log 10 scale on the x axis.
Above: histogram of Phase 4 clinical trial costs using a log 10 scale. You can use the button to toggle through the other phases.
At Fast Data Science, we are working on the next level of clinical trial cost benchmarking: reference class forecasting. For the trial that you want to benchmark for, we can use transformers and vector embeddings to identify similar trials from our database, and apply a correction for inflation.
The tool will display the estimated cost, a lower and upper bound, and the past trials that the cost estimate was based on.
Find out about trial cost benchmarking
As an alternative to cost benchmarking, you can model a trial cost, by identifying all activities associated with the trial (such as the assessments in the schedule of events), and sum these items to create a budget. This is complex and time consuming, but creates an itemised budget. The Clinical Trial Risk Tool allows you to build a site budget directly from the protocol PDF.
Above: the Clinical Trial Risk Tool lets you upload a protocol and will automatically check the protocol design against its checklist, as well as generating a site budget for you.
Upload your clinical trial protocol and create a budget with AI
