Are clinical trial investigators wasting billions of bucks on mission creep?

Ken Getz, assistant professor at Tufts Center for the Study of Drug Development (CSDD), has come out with a new analysis showing that one in 5 procedures performed in "later" stage drug development is done in pursuit of "supplementary secondary, tertiary, and exploratory endpoints." And it isn't cheap, adding an average cost of $1.1 million per trial spent in pursuit of "extraneous data."

Crunch the numbers on how this translates to the entire industry, and Getz concludes that investigators rack up a tab of $4 billion to $6 billion a year in pursuit of non-core objectives.

"The impetus to collect these data is strong, and until now there has been no systematic assessment of this practice," says Getz, a high-profile figure in the world of drug development. "We believe our findings offer a framework that pharmaceutical and biotechnology companies can use to streamline protocol designs, improve clinical research performance, and reduce development costs."  

Three key takeaways from the Tufts CSDD summary:

  • An average 22.3% of all clinical trial procedures are considered to be non-core, including 17.7% of Phase II procedures and 24.7% of Phase III procedures.
  • Half of all procedures--54.3% of Phase II procedures and 47.9% of Phase III--support primary and key secondary endpoints.
  • The typical clinical trial protocol has an average of 13 endpoints, with the number of less essential endpoints per protocol nearly doubling the average level observed 10 years ago.

No doubt there is quite a bit of money wasted on drug studies. But investigators often set out to widen the parameters of a clinical trial in search of data that could help position a new product, better define future studies or discover added reasons for reimbursement. Getz's main point--get serious about distinguishing the real value of non-core objectives--is one everyone in clinical development should take to heart. 

- here's the press release