Inefficient clinical trials are costing pharmaceutical development companies between $4 and $6 billion each year in unnecessary expenses, claims a new study just published by the Tufts Center for the Study of Drug Development (CSDD).
The problem is widespread, the report explains, affecting roughly one in five (22.3%) trials for more than $1 million per trial. A greater percentage of Phase III trials collected extraneous data (24.7) than Phase II trials (17.7%) did.
So what, exactly, is extraneous in each of these trials? Unnecessary endpoints and the expenses associated with collecting data for them, the report says.
"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," it explains.
Other metrics have been equally meteoric rises. Since 2000, for example, the median number of total procedures for Phase II and III trials has increased by 57% (117.1 in the '00-'03 period to 146.6 in the '08 to '11 period).
Any endpoints-usually supplementary, tertiary or exploratory-that fail to bear fruit have a cost, the report explains, even if those costs can represent a hedge against uncertainty. "The impetus to collect these data is strong: sponsors collect more data to interpret findings, guide development decisions, support adherence to protocol authoring templates and design practices, and anticipate requests from regulatory agencies, purchasers, and payors," the study notes.
Those non-core endpoints are responsible for 22.3% of all protocol procedures, the study explains, driving up costs for an uncertain benefit. Further, the study notes that approximately 10% of procedures meet the International Conference on Harmonisation's (ICH) good clinical practice (GCP) guidelines-a potential area for improvement.
So what is to be done? The report doesn't specify, though one of its authors explained in an accompanying statement that just knowing the problem exists is the first step toward solving it.
"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," Ken Getz, assistant professor at Tufts CSDD, said in a statement.
The study looked at 116 Phase II and III studies from 15 mid- and large-sized pharmaceutical and biotechnology companies between November 2011 and May 2012, and more than 25,000 individual protocol procedures were evaluated and classified.