As much as $5 billion in the cost of clinical trials could be saved by eliminating unnecessary procedures, according to a new study.

The study, conducted by researchers at the Center for the Study of Drug Development at Tufts University School of Medicine, found that clinical trial data gathered from as much as 25 percent of the of the procedures administered to patients may be unnecessary because they are not directly tied to the endpoints of clinical trials. The study authors say in aggregate, this represents between $3 billion to $5 billion in overall clinical trial costs annually. The authors presented the study at the Drug Information Association’s annual meeting at the end of June.

At a time of growing pressure to reign in cost in the drug development process, the study suggests that procedures identified as non-core to the protocol may represent opportunities for drug developers to significantly reduce clinical trial costs and improve productivity without sacrificing safety.

“This study is groundbreaking in that it links, for the first time, clinical trial economics to protocol complexity,” says Ken Getz, senior research fellow and research assistant professor at the Center for the Study of Drug Development, who served as principle investigator. “The results have been eye-opening for participating companies and will no doubt serve as a jumping off point for pharmaceutical and biotechnology companies to examine ways to reduce the number of non-core procedures to improve clinical trial efficiency and substantially reduce study budgets.”

The study was conducted over an eight month period and is based on data from 15 international sponsor companies of all sizes. Using software from Medidata, the researchers collected and analyzed more than 115 clinical trial protocols and categorize more than 22,000 medical procedures. About 25 percent of all clinical trial procedures were found not to be directly tied to the trial end-points as agreed upon prior to the study by the U.S. Food and Drug Administration for demonstrating the safety and efficacy of the drug or therapy in question. These procedures represented about 20 percent of the clinical trial’s budget or an estimated $1 million per clinical study.

“By distinguishing between core and non-core procedures early on in the trial process, this research underscores the critical roles study design and protocol development play in overall clinical trial costs,” says Marla Curran, director of clinical statistics and doctor of public health in biostatistics at GlaxoSmithKline. “Even with this study’s conservative estimate of the procedures organizations could potentially eliminate, it’s clear that the industry can take a closer look at trial design to improve efficiencies while still meeting regulatory requirements.”