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Compliance In Focus
Posted by John Lehmann on Fri, Nov 9, 2012

Inept Clinical Trial Endpoints Can Cost Billions

Here’s a staggering statistic for you- inefficient clinical trials are costing some companiesInept Clinical Trial Endpoints between $4 and $6 billion each year in unnecessary expenses. This is according to study data published by the Tufts Center for the Study of Drug Development (CSDD).

This report was also covered by an article on RAPS which points to the fact that the problem is widespread. However, in clinical trials the major issue lies in unnecessary endpoints and the expenses associated with collecting data to meet these endpoints. Trial endpoints can be crucial as they can be defined as “results, conditions, or events associated with individual study patients that are use to assess study treatments.” Nevertheless, something seems to be amiss if this becomes a wasteful aspect of the research process.

Other interesting finds noted in the report include:

  • 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 and 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.

While this data is resulting from a study of drug development costs, it sheds an interesting light on the idea of extraneous endpoints in clinical trials. If a study is not stream-lined with a well-written and well-defined protocol, the study is doomed from the start.  Endpoints in a clinical trial can be a challenging and critical study design decision. For more information on this aspect of a trial check out this useful presentation.

Why do you think the trend is for a wasteful increase in endpoints? Is there such a thing as too much information?

Photo Credit: 401(K) 2012

 

Topics: RAPS, Tufts Center for Study of Drug Development, Clinical Research

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