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 a statement from Medidata Solutions, which sponsored the study).

As an example, Tufts identified amendments made to protocols as a problem area, since these can greatly add costs since each change has a ripple effect. To be specific, each amendment adds 61 days and costs more than $450,000 to implement. Overall, Tufts found there 6.9 amendments to each protocol and 52 percent occur in Phase One, and 69 percent of trials had at least one amendment.

In fact, Tufts found that 18 percent of amendments were completely avoidable due to flaws in protocol design, or inconsistencies or errors in protocols. Another 19 percent were deemed somewhat avoidable due to difficulty recruiting patients or issues concerning feedback from investigators or trial sites. More than 115 clinical trial protocols provided by 15 drugmakers and biotechs were analyzed, by the way.

Meanwhile, costs related to physicians associated with non-core procedures total as much as $4 billion annually. Why so much? The non-core procedures require data management, monitoring and statistical analysis, among other activities. And so, if one includes these related trial costs, Tufts estimates that total non-core procedures can eventually represent an estimated $3 billion to $5 billion each year.

What to do? Avoid making so many amendments and limit the identifiable non-core procedures. To improve protocol feasibility, Tufts suggests creating internal, dedicated assessment panels and committees; obtain ‘real-time’ input from primary investigators, study staff, and contract research organizations; use better protocol authoring tools; and match primary and secondary endpoints with procedures to be performed.

“The study not only demonstrates the magnitude of the problem, it also offers a framework that helps companies identify which procedures to consider removing from the protocol,” Getz writes us. “If the procedure is not tied to an essential study objective, then they should be open to further scrutiny and, in some case, removal.”

By Ed Silverman