In the race to develop more drugs, the pharmaceutical industry may actually be wasting a lot of money for clinical trial procedures that are not absolutely necessary. In fact, data gathered from roughly 25 percent of procedures administered to patients are not only unnecessary, but can also be traced to as much as $5 billion in overall trial costs each year, according to a new study.
How can this be? Well, there is little to no data available on the incidence and magnitude of unused and irrelevant protocol data and associated costs, according to Ken Getz, a senior research fellow at the Tufts Center for the Study of Drug Development, who presented the findings at the recent Drug Information Association annual gathering. To be clear, core procedures were defined as those that support study endpoints or safety objectives.
With this in mind, Tufts set out to quantify some of the vagaries. For instance, 18 percent, or $1.1 million, of an average protocol budget is paid to perform non-core procedures, such as those that support secondary and exploratory endpoints. But this does not include staff time to collect, manage and analyze clinical data. The non-core procedures represent roughly 20 percent of a trial budget (here is astatement from Medidata Solutions, which sponsored the study). Read More