A Different Look at Protocol Procedure Complexity

February 5, 2016
Harold E. Glass, PhD

A substantial increase in procedure complexity should be reflected in increasing per patient costs of Phase III clinical trials,which is not true from this data.

Procedure complexity is frequently defined as the number of unique procedures and/or the amount of activity associated with a given procedure. But a substantial increase in procedure complexity should be reflected in increasing per patient costs of Phase III clinical trials, unless sites around the world have decided to perform a rapidly growing number of medical procedures at no additional cost to the commercial companies sponsoring the studies. This is probably not a widespread practice.

According to this article, clinical grant costs are not increasing. But neither has the total average cost-per-patient. We should expect some variation from year to year simply because new studies will reflect a different distribution of therapeutic areas.   

From two clinical grant benchmarking systems in use by sponsor companies and CROs, which use these databases to develop clinical grant cost figures in the United States. Organizations conducting nearly 80% of all Phase III clinical trials submit their clinical grant data to the IMS Health clinical grant database, GrantPlan, from which this data was gathered.

 

Source: University of the Sciences, Mayes College, using IMS Health Data.

Related Content:

News